Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Lung Neoplasms

Fatigue

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

All Drugs and Chemicals

Nicotine

Participants in the intervention group will receive ACT intervention, consisting of four individual sessions (First session by face to face, the last three sessions by Wechat) of 60-90 min each (once/week), in addition to usual care.

Participants randomized to the control group will receive usual care, including treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge.

Session 1:

This session aims to let the participants get familiar with the interventionist. The interventionist will tell them the purpose of the program and basic rules. And the interventionist will promise their privacy protection.

Session 2:

This session includes how to separate thoughts/feelings/sensations related to diagnose with advanced lung cancer and experience of fatigue with facts and see these feelings in an objective way with observing self.

Session 3:

This session mainly aims to help participants understand the importance of values, differentiate values from goals and clarify their personal values.

Session 4:

This session aims at helping patients practice to engaging in committed action based on chosen values, motivated to change behavior in consistency with life direction and health goal.

Acceptance and Commitment Therapy (ACT)

The usual care mainly includes treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge

Usual care

Huiyuan LI

Cho Lee Wong, PhD

Lung cancer is a malignant tumor that has transformed from a single cancer disease into one of the most striking global health problems. Lung cancer has an insidious onset, and most patients are first diagnosed with the middle and advanced stage. Cancer related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has lasting impact on physical, psychological and social functions, interferes with activities and participating in life events, thereby worsening the health-related quality of life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioral therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer.

A two-arm, assessor-blind randomized controlled trial will be conducted to investigate the effects of ACT on advanced lung cancer patients compared to usual care. Participants in the same ward will be randomized at a 1:1 ratio to the intervention group or control group. Block randomization will be conducted by an independent research assistant using randomly varying block size of 4, 6 to avoid selection bias. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer. The Specific objectives are: 1) To investigate the effects of ACT on primary outcomes: fatigue interference and health-related quality of life compared to control group at post-intervention and three months follow-up. 2) To investigate the effects of ACT on the secondary outcomes: cancer-related fatigue, depressive symptoms, anxiety, distress and exercise capacity and process outcomes including psychological flexibility, ACT related variables (acceptance and cognitive defusion) at post-intervention and three months follow-up.

Participants are assigned to two groups in parallel for the duration of the study. Participants in Group A receive Acceptance and Commitment Therapy based on usual care. Participants in Group B receive usual care.

The outcomes assessors who are independent with the research will be trained before formally conducting data collecting.

Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer

Effectiveness of Acceptance and Commitment Therapy on Fatigue Interference and Health-related Quality of Life Among Patients With Advanced Lung Cancer: A Randomized Controlled Trial

A 13-item instrument that measures the intensity and interference of fatigue over the previous 7 days. The first four items are used to assess the intensity of fatigue, Item 5 - Item 11 are to assess the degree to which fatigue in the past week was judged to interfere with different aspects, such as general activity, bathe and dress ability, work activity, concentration ability, relation with others, enjoyment of life and mood, using a 11-point Likert scale ranging from 0 (no interference) to 10 (extreme interference). 0 indicates no fatigue and 127 indicates the worst fatigue intensity and interference.

Change= (One week after the intervention score - Baseline score)

A 13-item instrument that measures the intensity and interference of fatigue over the previous 7 days. The first four items are used to assess the intensity of fatigue, Item 5 - Item 11 are to assess the degree to which fatigue in the past week was judged to interfere with different aspects, such as general activity, bathe and dress ability, work activity, concentration ability, relation with others, enjoyment of life and mood, using a 11-point Likert scale ranging from 0 (no interference) to 10 (extreme interference). 0 indicates no fatigue and 127 indicates the worst fatigue intensity and interference.

Change= (Three months after the intervention score - Baseline score)

36 items scored from 0 (not at all) to 4 (very much) to assess QoL of lung cancer patients, including 5 domains: physical, social/family, emotional, and functional well-being, and additional concerns about lung cancer. The overall score can be obtained by adding all subscale scores. 0 indicates no quality of life and 144 indicates the highest quality of life.

Change= (One week after the intervention score - Baseline score)

36 items scored from 0 (not at all) to 4 (very much) to assess QoL of lung cancer patients, including 5 domains: physical, social/family, emotional, and functional well-being, and additional concerns about lung cancer. The overall score can be obtained by adding all subscale scores. 0 indicates no quality of life and 144 indicates the highest quality of life.

Change= (Three months after the intervention score - Baseline score)

20-item self-reported instrument testing the subjective experience of fatigue. 20 indicates the low level of fatigue and 80 indicates the high level of fatigue. 20 indicates low level of fatigue and 80 indicates the high level of fatigue.

Change= (One week after the intervention score - Baseline score)

20-item self-reported instrument testing the subjective experience of fatigue. 20 indicates the low level of fatigue and 80 indicates the high level of fatigue. 20 indicates low level of fatigue and 80 indicates the high level of fatigue.

Change= (Three months after the intervention score - Baseline score)

A 9-item scale to measure the severity of depressive symptom ranged from 0 to 27, in which each item can be score from 0 (not at all) to 3 (nearly every day). 0 indicates no depression and 27 indicates severe depression.

Change= (One week after the intervention score - Baseline score)

A 9-item scale to measure the severity of depressive symptom ranged from 0 to 27, in which each item can be score from 0 (not at all) to 3 (nearly every day). 0 indicates no depression and 27 indicates severe depression.

Change= (Three months after the intervention score - Baseline score)

A brief self-report instrument to measure severity of anxiety with 7 items ranged from 0 to 21. 0 indicates no anxiety and 21 indicates severe anxiety.

Change= (One week after the intervention score - Baseline score)

A brief self-report instrument to measure severity of anxiety with 7 items ranged from 0 to 21. 0 indicates no anxiety and 21 indicates severe anxiety.

Change= (Three months after the intervention score - Baseline score)

It has 22 items containing three domains: Intrusion, Avoidance, and Hyperarousal subscales using a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely) ranged from 0 to 88. 0 indicates low level of distress and 88 indicates severe distress.

Change= (One week after the intervention score - Baseline score)

It has 22 items containing three domains: Intrusion, Avoidance, and Hyperarousal subscales using a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely) ranged from 0 to 88. 0 indicates low level of distress and 88 indicates severe distress.

Change= (Three months after the intervention score - Baseline score)

Including the type of exercise (What kind of exercise do you usually do?); the intensity of exercise (What intensity of exercise do you usually do? Low/moderate/high?); frequency of exercise per week (How many times do you exercise on average a week?); and the duration of exercise each time (min) (How long will you take each exercise?) Change= (One week after the intervention score - Baseline score)

Including the type of exercise (What kind of exercise do you usually do?); the intensity of exercise (What intensity of exercise do you usually do? Low/moderate/high?); frequency of exercise per week (How many times do you exercise on average a week?); and the duration of exercise each time (min) (How long will you take each exercise?) Change= (Three months after the intervention score - Baseline score)

A comprehensive ACT process measure to evaluate the level of psychological flexibility (and constituent sub-process) within the ACT model with 18 items ranged from 18 to 90. 18 indicates low level of psychological flexibility and 90 indicates the high level of psychological flexibility.

Change= (One week after the intervention score - Baseline score)

A comprehensive ACT process measure to evaluate the level of psychological flexibility (and constituent sub-process) within the ACT model with 18 items ranged from 18 to 90. 18 indicates low level of psychological flexibility and 90 indicates the high level of psychological flexibility.

Change= (Three months after the intervention score - Baseline score)

18-item questionnaire to measure experiential avoidance, in which participants response the possibility that they accept or avoid repulsive thoughts and feelings to each item using a 7-point Likert scale (1 = never true to 7 = always true) ranged from 18 to 126. The higher the overall score, the greater level of experiential avoidance or low level of acceptance. 18 indicates low level of acceptance and 90 indicates the high level of acceptance.

Change= (One week after the intervention score - Baseline score)

18-item questionnaire to measure experiential avoidance, in which participants response the possibility that they accept or avoid repulsive thoughts and feelings to each item using a 7-point Likert scale (1 = never true to 7 = always true) ranged from 18 to 126. The higher the overall score, the greater level of experiential avoidance or low level of acceptance. 18 indicates low level of acceptance and 90 indicates the high level of acceptance.

Change= (Three months after the intervention score - Baseline score)

An instrument to measure cognitive fusion, one of the components in the model of psychopathology of ACT. It has 9 items scored by 7-point Liker scale (1 = never true to 7 = always true) ranged from 9 to 63. 9 indicates low level of cognitive fusion and 63 indicates the high level of cognitive fusion.

Change= (One week after the intervention score - Baseline score)

An instrument to measure cognitive fusion, one of the components in the model of psychopathology of ACT. It has 9 items scored by 7-point Liker scale (1 = never true to 7 = always true) ranged from 9 to 63. 9 indicates low level of cognitive fusion and 63 indicates the high level of cognitive fusion.

Change= (Three months after the intervention score - Baseline score)

Chinese University of Hong Kong

Principal Investigator

Anxiety Disorders

Depressive Disorder

Depression

Head and Neck Neoplasms

ACT will be conducted in a group of 10 for each session. The ACT modules covered over 8 sessions, 1 hour in each session. The sessions will be held every week according to the patient's appointment date for chemotherapy treatment.

MBSR will be conducted in a group of 10 for each session. The MBSR modules covered over 8 sessions, 1 hour in each session. The sessions will be held every week according to the patient's appointment date for chemotherapy treatment.

The subjects in the control group will be assigned in the wait-list where either ACT or MBSR will be provided after the study has been completed.

ACT is a third generation cognitive behavioral approach which uses acceptance and mindfulness processes, and commitment and behavior change processes to produce psychological flexibility. ACT increase adaptive coping through acceptance, cognitive defusion, mindfulness, and perspective-taking exercises while supporting cancer survivors in aligning behavior with their personal values. The objectives of the therapy are for client to learn to focus on behaviors and actions that are in line with their individual values - the things they care about most. ACT facilitates development and maintenance of health behavioral improvements by targeting internal barriers, such as emotional discomfort and self-defeating thoughts, and by fostering connection and commitment to personal values associated with self-management of positive health behaviors. ACT is useful in cancer patients, because it can help them to deal with the negative emotions caused by cancer instead of avoiding these.

The term 'mindfulness' refers to mindful awareness as a way of being - a knowing and experiencing of feelings, thoughts, and perceptions as they arise and pass away each moment. It is a way of relating to all experiences in an open, receptive way, without judging experiences as good or bad (grasping at them or pushing them away). Mindfulness employed two styles of meditations: concentrative meditation involves intentionally focusing attention on a chosen object (e.g. the sensations of breathing) in a sustained way, while receptive meditation involves monitoring the content of experience (e.g. sensations, emotions, thoughts, sounds, etc.) in a non-reactive and non-judgmental way, from moment to moment, with the goal being to recognize the nature of emotional and cognitive patterns. Mindfulness-based stress reduction (MBSR) is an 8-week, standardized group intervention consisting of mindfulness meditation and gentle yoga that is designed to have applications for stress, pain, and illness

Mindfulness-based Stress Reduction (MBSR)

Mohammad Farris Iman Leong Bin Abdullah, Dr Psych

Nurul Izzah Shari, PhD

Head and neck cancer is a group of biologically similar cancers which cause deleterious impact, such as the complication of facial disfigurement which may increase the psychological vulnerability of patients due to the society's emphasis on physical attractiveness. The appearance of facial disfigurement can increase depression and reduced quality of life (QoL) in head and neck cancer patients. Among the positive psychology developed in cancer patients despite their negative experience of cancer and the adverse effects of its treatment are posttraumatic growth (PTG) and hope which may enhance the QoL of cancer patients. Several psychosocial interventions have been suggested to enhance positive psychology in cancer patients and increase in their QoL. Among the psychosocial interventions shown to be promising include mindfulness-based intervention and newer psychosocial intervention, such as acceptance and commitment therapy (ACT). Data is lacking on the efficacy of mindfulness-based stress reduction (MBSR) and acceptance and commitment therapy (ACT) on enhancing positive psychology (such as PTG, optimism and hope) and QoL, while reducing depression and anxiety among head and neck cancer patients. This is a multicentre 3-armed longitudinal double blind randomized control trial aimed to test the study hypotheses of:

1. Head and neck cancer patients in the acceptance and commitment therapy (ACT) group reported significantly increase in posttraumatic growth (PTG), hope, optimism, and quality of life as well as significantly reduced depression, anxiety, and experiential avoidance compared with those in the control group at post-intervention and 6 months after intervention when compared with pre-intervention.
2. Head and neck cancer patients in the mindfulness-based stress reduction (MBSR) group reported significantly increase in posttraumatic growth (PTG), hope, optimism, and quality of life as well as significantly reduced depression, anxiety, and experiential avoidance compared with those in the control group at post-intervention and 6 months after intervention when compared with pre-intervention.
3. There are no difference in the increase in posttraumatic growth (PTG), hope, optimism and quality of life, and decrease in depression, anxiety, and experiential avoidance between the MBSR and ACT groups at post-intervention and 6 months after intervention.

As head and neck cancer differ from other types of cancer due to the complication of facial disfigurement which may increase the psychological vulnerability of patients due to the society's emphasis on physical attractiveness. Moreover, a number of devastating complications of the cancer itself and the side effects of its treatment such as fatigue, pain, problem with speech and swallowing, breathing problem, mucositis, xerostomia, and trismus which further exerts detrimental effects on many functions and activities of daily living which causes further psychological distress and decreasing quality of life. Hence, it is of utmost importance to investigate on psychosocial interventions which could enhance PTG, hope, optimism and QoL as well as reducing internalized stigma and experiential avoidance of head and neck cancer patients which in turn bring about the ultimate outcome of restoring mental and physical well-being of the cancer survivors. Acceptance and commitment therapy (ACT) and mindfulness-based stress reduction (MBSR) have been reported to enhance positive psychology and alleviate psychological distress in cancer patients. But the effect of ACT and MBSR on PTG, hope, optimism, QoL, depression, anxiety and experiential avoidance among head and neck cancer patients have not been studied. Hence, there is a need to conduct a 3-armed randomized control trial to evaluate the effects of ACT and MBSR on PTG, hope, optimism, QoL, internalized stigma and experiential avoidance compared with control group with no intervention across time.

Below are the objectives of this study:

General objective:

To examine the effects of acceptance and commitment therapy (ACT) and mindfulness-based stress reduction (MBSR) on posttraumatic growth (PTG), hope, optimism, quality of life, depression, anxiety, and experiential avoidance among head and neck cancer patients.

Specific objectives:

1. To examine the changes in the degree of posttraumatic growth (PTG), hope, optimism, quality of life, depression, anxiety, and experiential avoidance of head and neck cancer patients in the acceptance and commitment therapy (ACT) group compared with those in the control group at post-intervention, 6 months and 12 months after intervention compared with pre-intervention.
2. To examine the changes in the degree of posttraumatic growth (PTG), hope, optimism, quality of life, depression, anxiety, and experiential avoidance of head and neck cancer patients in the mindfulness-based stress reduction (MBSR) group compared with those in the control group at post-intervention, 6 months and 12 months after intervention compared with pre-intervention.
3. To determine whether there are any difference in the changes in the degree of posttraumatic growth (PTG), hope, optimism, quality of life, depression, anxiety, and experiential avoidance between those in the acceptance and commitment therapy (ACT) group and mindfulness-based stress reduction (MBSR) group at post-intervention, 6 months and 12 months after intervention.

Study Setting:

The study will be conducted the Oncology and Otorhinolaryngology unit of Advanced Medical and Dental Institute, Universiti Sains Malaysia and Oncology and Otorhinolaryngology unit of Universiti Kebangsaan Malaysia Medical Centre. The Oncological and Otorhinolaryngology units of AMDI, USM have about 200-250 registered head and neck cancer patients currently under follow up. These units receive new cases of head and neck cancer every week. While the Department of Otorhinolaryngology and Department of Oncology of UKMMC have an estimated 350-400 registered head and neck cancer patients while the Department of Oral and Maxillofacial Surgery of UKMMC has an estimated 100-150 registered oral cancer patients under follow up (oral cancer is grouped under head and neck cancer).

Study design:

This is a multicentre 3-armed longitudinal double blind randomized control trial which is expected to run for a duration of 3 years (from July 2021 to June 2024).

Sample size:

The sample size is determined based on G-Power 3.1.9.2 for repeated measures, between-within interaction ANOVA. Based on the previous study, the sample size was calculated based on the continuous response, Post-traumatic growth inventory from the study conducted by Labelle et al. (2014), with medium effect size (0.23), an alpha of 0.05, two-tailed. The results indicated that the total sample of 63 for three equal-sized groups is needed to achieve a power of 0.95. In anticipation of a drop-out rate of 30%, the estimation for sample size is 90 respondents for total respondents and 30 respondents for each group.

Sampling method:

Sampling method use in this study is by consecutive sampling.

Recruitment of subjects:

The participants were recruited from the source population which included all newly diagnosed head and neck cancer patients who has been treated only with surgery or still remain untreated registered under the Oncology and Otorhinolaryngology unit of Advanced Medical and Dental Institute, Universiti Sains Malaysia and Oncology and Otorhinolaryngology unit of Universiti Kebangsaan Malaysia Medical Centre. These patients will be approached by the research team and explained on the study objectives and procedures.

Randomization:

Participants will be randomized into three groups, such as acceptance and commitment therapy (ACT) group, mindfulness-based stress reduction (MBSR) group and control group on waiting list. The participants will be randomized into one of the three groups in a 1:1:1 allocation ratio by block randomization. The allocation sequence is concealed in opaque, sequential numbered envelope.

Data collection:

Data collection is carried out by a research assistant who is not involved in conduct of the study and data analysis. In the pre-intervention phase (T1), the participants in all three groups are administered the following questionnaires:

(i) Socio-demographic and clinical questionnaire which includes age, gender, marital status, employment, education, monthly income, religion, stage of cancer and type of head and neck cancer.

(ii) The Posttraumatic Growth Inventory-Short Form (PTGI-SF) to assess the degree of PTG of the participants (iii) The Dispositional Hope Scale to assess the degree of hope of the participants (iv) The Hospital Anxiety and Depression Scale (HADS) to assess the severity of depressive and anxiety symptoms (v) The Life Orientation Test-Revised (LOT-R) to assess the degree of optimism (vi) The Acceptance and Action Questionnaire (AAQ-II) to assess the degree of experiential avoidance (vii) The Functional Assessment of Cancer Therapy - Head \& Neck (FACT-H \& N) to assess the degree of quality of life

Then the assessments with the following questionnaires are repeated immediately post-intervention (T2) and 6 months after intervention (T3) among participants in all the three groups:

(i) The Posttraumatic Growth Inventory-Short Form (PTGI-SF) to assess the degree of PTG of the participants (ii) The Dispositional Hope Scale to assess the degree of hope of the participants (iii) The Hospital Anxiety and Depression Scale (HADS) to assess the severity of depressive and anxiety symptoms (iv) The Life Orientation Test-Revised (LOT-R) to assess the degree of optimism (v) The Acceptance and Action Questionnaire (AAQ-II) to assess the degree of experiential avoidance (vi) The Functional Assessment of Cancer Therapy - Head \& Neck (FACT-H \& N) to assess the degree of quality of life

Blinding:

The participants will be blinded for the study as randomization into designated groups are conducted by a research assistant not involved in the study and the allocation is concealed in opaque, sequential numbered envelope. Therefore, the participants will not know which group they are allocated to. Although participants in the ACT and MBSR groups undergo psychosocial intervention earlier, the participants in the control group (who are assigned in the waitlist) will also undergo ACT once they have completed assessments at three-time frames (T1, T2, and T3). All the participants will also be blinded regarding the hypotheses of the study.

The researchers will be blinded for the study as randomization of participants into designated groups are conducted by a research assistant not involved in the conducting the study and data analysis. Data collection will also be caried out by the research assistant who is not involved in conducting the study and data analysis and blinded regarding the hypotheses of the study. Moreover, the data analysis will be performed out by statisticians who are not involved in conducting the study and blinded regarding the hypotheses of the study.

Interventions:

Both ACT and MBSR intervention will be conducted in a group of 10 for each session. The ACT and MBSR modules covered over 8 sessions, 1 hour in each session. The sessions will be held every week according to the patient's appointment date for chemotherapy treatment.

Therapists:

The trainee therapists are two post-graduate students who enrolled in their Doctor of Philosophy (Ph.D.) in psychology. They received training approximately 16 hours of ACT intervention and 16 hours of MBSR intervention. In ACT intervention training, trainee therapists will learn about general core concepts of ACT, principals, model, framework, and philosophy. Besides, they also will learn how to apply ACT therapy including engagement with each element in hexaflex, integrating exercises, metaphors, techniques, and mindfulness in ACT sessions and clinical practices. In the MBSR training, the trainee therapists will learn the basic overview and concepts of MBSR including mindfulness, body scan and yoga. Besides, they also will experiential learning about formal and informal practices, recording and home practices.

Data analysis:

Data analysis will be performed using SPSS version 26 software. Descriptive statistics will be used to analyze demographic data while inference analyses will be used to evaluate the significant difference between intervention and waitlist groups. In order to identify the efficacy of acceptance and commitment therapy (ACT) and mindfulness-based stress reduction (MBSR) on the measured variables, several tests will be carried out. The comparison of mean differences pre-intervention (T1), post-treatment (T2) and 6 months after intervention (T3) will be examined to determine whether any changes in the measured variables (PTG, hope, optimism, QoL, depression, anxiety, and experiential avoidance) in the ACT, MBSR and control groups across the three timelines by using repeated measure ANOVA. Then, the mean differences of measured variables (PTG, hope, optimism, QoL, depression, anxiety, and experiential avoidance) between ACT, MBSR and control groups at each timeline will be determined by using the one-way ANOVA. The effect sizes will be calculated to determine how substantially patients' perception towards measured variables changed with and without ACT and MBSR interventions. Statistical significance is set at p \< 0.05 and two-tailed.

RCT of Acceptance and Commitment Therapy Versus Mindfulness-based Stress Reduction in Head and Neck Cancer

Randomized Controlled Trial of Acceptance and Commitment Therapy Versus Mindfulness-based Stress Reduction in Newly Diagnosed Head and Neck Cancer: Assessing Their Effect on Positive Psychology, Depression, Anxiety, and Quality of Life

Posttraumatic Growth Inventory-Short Form (PTGI-SF) is the shorter version of the original Posttraumatic Growth Inventory and consists of 10 items where each of the 5 factors in posttraumatic growth is measured by 2 items. The higher the PTGI-SF score, the higher the level of posttraumatic growth in the individual being assessed. PTGI could be substituted by PTGI-SF with little loss of information. The PTGI-SF Malay version has good internal consistency which demonstrated Cronbach's alpha of 0.887 with the Cronbach's alpha of the 5 factors ranging from 0.700 to 0.813. Intraclass correlation coefficient (ICC) gave a good score of 0.75 (95% CI: 0.67-0.81). Confirmatory factor analysis demonstrated 5 factors in which there are 2 items for each factor as in the original version of PTGI-SF. In this study, it is used to assess level of posttraumatic growth among the participants.

Functional Assessment of Cancer Therapy - Head \& Neck (FACT-H \& N) is a self-reported tool which measures quality of life in patients with head and neck cancer. FACT-HN consists of 39 items and consists of 5 subscales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items) and head \& neck cancer additional concerns (12 items). Each item is scored in a 5-point Likert scale ranging from 0= Not at all to 4= Very much. The higher the score, the greater is the degree of QoL. The tool also registered excellent psychometric properties. The FACT-H \& N has been translated and validated in the Malaysian cancer population. All the subscales have moderate to good internal consistency with Cronbach's α ranging from 0.65 to 0.87. In this study, it is used to assess level of QoL among the participants.

Acceptance and Action Questionnaire (AAQ-II) measured experiential avoidance or psychological inflexibility. AAQ II is the second version and revised from the original version which consists of a shorter version (7 items) with better psychometric consistency. The scores were calculated by summing up the seven items. Higher scores indicated higher levels of psychological inflexibility. Validation of the Malay version of the AAQ-II indicated that the tool had excellent internal consistency with Cronbach's α of 0.91 and was a unidimensional scale that measured psychological inflexibility/experiential avoidance. In this study, it is used to assess the degree experiential avoidance in the participants.

The Hospital Anxiety and Depression Scale (HADS) is a self-rated questionnaire that assesses patients' severity of anxiety and depression using seven items designated for depression subscale and seven items for anxiety subscale. Each item scores from 0 to 3, and the range of total score for both depressive and anxiety subscales ranged from 0 to 21 per subscale. The cut-off for caseness of depression is 8/21 and the cut-off for caseness of anxiety is also 8/21. The anxiety subscale has a sensitivity of 0.9 and specificity of 0.78 and the depression subscale has a sensitivity of 0.83 and specificity of 0.79. The Malay version of HADS has been validated in Malaysian breast cancer patients and exhibited acceptable to good internal consistency for its total score and subscales with Cronbach's α ranging from 0.73 to 0.87.

Dispositional Hope Scale is a self-rated 12 items scale which assesses the responder's level of hope. It comprised of 2 subscales which incorporates Snyder's cognitive model of hope i.e. (a) Agency (goal-directed energy) and (b) Pathways (planning to accomplish goals). 4 of the 12 items assess agency while another 4 items assess pathways. The other 4 items are fillers. Each item is scored using Likert-point scale from Definitely False to Definitely True. The Malay version of Hope Scale demonstrated Cronbach's alpha of 0.716. Intraclass correlation coefficient (ICC) gave a good score of 0.67 (95% CI: 0.57-0.75). Confirmatory factor analysis demonstrated 2 factors in which there are 4 items for each factor as in the original version of Hope Scale. In this study, it is used to assess level of hope among the participants.

The Life Orientation Test-Revised (LOT-R) has 6 coded items with 3 framed in each direction, which are optimism and pessimism. The revision omitted or rewrote items that did not focus on explicit expectations. It has good internal consistency and stable over time. The positive and negative subsets are more strongly related to each other than those in the original Life Orientation Test. The Malay version of LOT-R demonstrated intraclass correlation coefficient (ICC) gave a good score of 0.62 (95% CI: 0.50-0.71). Confirmatory factor analysis demonstrated 2 factors in which there are 3 items for each factor as in the original version of LOT-R with factor loading ranging from 0.46 to 0.72. In this study, it is used to assess the level of optimism of the participants.

Xinxiang medical university

Universiti Sains Malaysia

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Weekly video conference groups led by a trained facilitator introducing key concepts of ACT

Weekly video conference groups led by a trained facilitator introducing key concepts of CBSM

Patients' usual health care as received over the duration of the pilot trial

This intervention consists of 8, 90-minute online group sessions delivered via video conference. Content will be developed by tailoring an ACT intervention to the specific needs of women with MBC, by using qualitative data gathered in patient focus groups. The intervention will incorporate key concepts of ACT (i.e., creating meaning and purpose in life via coping skills, activities in line with patients' values, and mindfulness meditation).

This intervention consists of 8, 90-minute online group sessions delivered via videoconference. Content is drawn from a standard published CBSM intervention previously tested in other studies. The intervention incorporates key concepts of CBSM (i.e., managing stress via deep breathing and relaxation, identifying distorted thoughts,cognitive restructuring, and effective interpersonal communication).

Cognitive Behavioral Stress Management (CBSM)

The purpose of this study is to develop and tailor an intervention program to improve the quality of life in women living with metastatic breast cancer. In the first phase of this study, we conducted patient focus groups to gather information about the unique challenges of living with MBC and what kinds of support women would like to receive in a tailored Acceptance and Commitment Therapy (ACT) intervention. In the second phase of the study, we will conduct a three-arm randomized controlled trial to the tailored ACT intervention with both a Cognitive Behavioral Stress Management (CBSM) intervention and usual care. The CBSM and ACT intervention groups will meet with a trained facilitator and 8-9 other patients, once per week via videoconference for 90 minute sessions over the course of 8 weeks.

Patients participating in the online pilot will be randomized to 1 of 3 study arms: 1) a usual care control, 2) CBSM, and 3) ACT. Women taking part in the intervention trial (i.e. women living with Stage IV \[M1\] breast cancer) will complete self-report psychosocial measures online at four assessments. Change across time will be assessed from baseline to mid-intervention (Week 4 of 8), immediately post-intervention (Week 8), and a one month follow-up.

Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

Optimizing Quality of Life in Women Living With Metastatic Breast Cancer: Feasibility and Preliminary Efficacy of a Tailored, eHealth Supportive Oncology Intervention

Using the previously validated Measure of Current Status (MOCS) Self-Efficacy Scale, change in coping self-efficacy will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

Using the previously validated Acceptance and Action Questionnaire-II, change in acceptance will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

Using the previously validated Open and Engaged State Questionnaire, change in open and engaged state will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

Using the previously validated NIH PROMIS profile, change in HRQoL will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

Using the previously validated Functional Assessment of Cancer-Therapy-Breast (FACT-B), change in wellbeing and symptom bother will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

Using the previously validated PROMIS Short Forms for Meaning and Purpose and Positive Affect, change in meaning and purpose in life and positive affect will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

Using the previously validated PROMIS Short Forms for Social Isolation, Emotional Support, and Informational Support, change in social support will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

American Cancer Society, Inc.

Northwestern University

Assistant Professor

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Sclerosis

Tuberous Sclerosis

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

Patients randomly allocated to this arm will receive treatment immediately. They will receive 6-12 sessions of ACT while patients allocated to the waitlist control arm do no receive any treatment.

Patients randomly allocated to this arm will receive a delay in the treatment they receive. After a 12-week wait they will receive 6-12 sessions of ACT, while patients allocated to the immediate treatment arm receive no treatment for an equal duration.

Acceptance and commitment therapy (ACT) is an evidence-based psychological therapy that has been successfully used to improve physical and mental health among children and adults with chronic conditions. It is a "third wave" cognitive behavioural therapy that encourages openness to and awareness of the present moment in order to help participants maintain behaviours consistent with their life goals. ACT fosters engagement with, rather than avoidance of, painful experiences to move towards acceptance of unchangeable difficulties alongside building a rich and meaningful life despite the presence of ongoing difficulties. This gives ACT strong face validity for application to TCS patients where there can be permanent cognitive impairment and unavoidable ongoing physical symptoms and functional limitations.

Sam Amin, MBCHB MSc PhD

The study will assess the acceptability and feasibility of a randomised controlled trial of 6-12 sessions of remotely-delivered Acceptance and Commitment Therapy (ACT) versus waitlist control. Waitlist control will involve a delay in the offer of ACT sessions for 12 weeks. Participants may access all services as usual in this time. Follow-up assessments will be conducted at 12-, 24 and 48 weeks post-randomisation to measure effectiveness.

Tuberous Sclerosis Complex (TSC) is a genetic disease caused by mutations in the tumour suppressor genes TSC1 and TSC2. The clinical hallmarks of the disease are the growth of benign tumours in various organs such as the brain, kidneys and skin. Seizures are present in around 60% of the population and neurodevelopmental problems such as attention deficit disorder and autism are common. Anxiety and depressive disorders are similarly linked and at the psychosocial level, there is increasing evidence of the effect of TSC on self-esteem, family functioning and peer relationships resulting in poorer quality of life. Despite these difficulties, no unique treatments, and almost no effective evidenced psychological treatments for TSC are available.

This trial aims to assess the feasibility and acceptability of Acceptance and Commitment Therapy (ACT) as a psychological treatment to improve quality of life among adolescents and young adults with TSC. ACT is a cognitive behavioural therapy that helps participants accept difficulties that they are unable to change. There is strong evidence for ACT's clinical effectiveness amongst patients with chronic diseases. The intervention will be delivered to participants aged 11-24 with TSC and sufficient cognitive and speech capabilities to take part. This will be delivered remotely via secure video-conferencing software. Our primary hypothesis is that ACT will be acceptable and feasible delivered remotely and may yield clinical improvements in health and quality of life.

The study will be a 12-week, waitlist controlled randomised clinical trial. Participants will be randomised to receive 12-weeks treatment either immediately or following a 12-week wait. The treatment will be ACT adapted for 11-24-year olds who have TSC. Treatment will involve 6 to 12 weekly sessions of ACT of up to one hour each in length. Clinical outcomes will be assessed unblinded at baseline, 12, 24 and 48 weeks from randomisation. As a feasibility and acceptability study a range of physical and mental health outcomes are assessed. All clinical outcomes focus on health, wellbeing and quality of life from baseline to 12 week (3-month) follow-up amongst those offered ACT immediately versus waitlist controls.

Randomised controlled trial of 6-12 sessions of ACT versus waitlist control. Waitlist control will involve a delay in the offer of ACT sessions for 12 weeks.

The study design is an unblinded, waitlist-controlled, randomised controlled trial (RCT). Randomisation will be conducted using established randomisation software RedCap. Researchers will not be blind to trial arm allocation.

Acceptance and Commitment Therapy in Tuberous Sclerosis Complex

Randomised Controlled Trial of Acceptance and Commitment Therapy in Tuberous Sclerosis Complex

The proportion of patients showing interest who then consent to the trial and complete the intervention.

The session attendance rate compared to feasibility benchmarks.

Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.

A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.

A brief 7-item self-report measure assessing psychological inflexibility, which is the central treatment target for ACT. Validated for use among patients aged 16 and over. Minimum score = 7; maximum score = 49. Higher scores indicate worse outcome.

A brief self-report measure of psychological inflexibility, for children (11 to 15 year old participants). Minimum score = 0; maximum score = 32. Higher scores indicate worse outcome.

A brief self-reported assessment of wellbeing and mental health. Minimum score = 7 score; maximum = 49. Higher scores indicate worse outcome. Minimum score = 0; maximum score = 49. Higher scores indicate worse outcome.

A brief self-reported measure of generalised anxiety symptoms using 4-point Likert scales based on diagnostic criteria. Minimum score = 0; maximum score = 21. Higher scores indicate worse outcome.

Assesses symptoms of depression using self-reported 4-point Likert scales based on diagnostic criteria for major depression. Minimum score = 0; maximum score = 27. Higher scores indicate worse outcome.

A research instrument developed to collect information on service receipt, service-related issues and income. In addition, the Client Service Receipt Inventory collects information on school attendance in the 3-months prior to assessment.

Assesses behavioural, intellectual, learning and psychiatric impact of TSC.

A 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents

Participant experiences of treatment as described in semi-structured qualitative interviews

The Tuberous Sclerosis Association

University College, London

University Hospitals Bristol and Weston NHS Foundation Trust

Chronic Pain

Pain

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurofibroma, Plexiform

Neurologic Manifestations

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Chronic Graft Versus Host Disease

Neurofibromatosis

Neurofibromatosis Type 1

2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats.

Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)

Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain.

Staci M Peron, Ph.D.

Background:

- People with neurofibromatosis type I (NF1) and plexiform neurofibroma (PN) tumors often have chronic pain that his hard to control. People usually take medicines for the pain, but they may not work well and might cause side effects. A new strategy called Acceptance and Commitment Training (ACT) may help these people cope with chronic pain. ACT focuses on things like values and living in the moment.

Objective:

- To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain.

Eligibility:

- People age 16-34 who have NF1, 1 or more PN tumors, and pain that interferes with their daily functioning.

Design:

* Participants will be screened with a physical exam, medical history, and questions about their pain.
* Participants will fill out questionnaires about their pain and feelings. Their heart rate will be measured via electrocardiogram (ECG).
* Participants will be divided into 2 groups randomly. One will wait 8 weeks.
* The other will start training right away.
* Participants will have 2 two-hour sessions with an ACT trainer. They will learn techniques for setting goals based on personal values and other ways to cope with pain. They will get a workbook and a compact disc (CD) to take home for practice.
* Participants will do practice exercises at home between sessions. They will get weekly emails with a practice exercise. They will join video chat sessions via home computer with their trainer.
* All participants will return to National Institutes of Health (NIH) after 8 weeks for questionnaires and an ECG. The wait group will then start training. They will return 8 weeks later for questionnaires and an ECG.
* Six months later, they will complete questionnaires from home by computer.

BACKGROUND:

* Neurofibromatosis type 1 (NF1) is a genetic disorder that affects approximately 1 in 3,500 individuals.
* A number of common clinical manifestations, including plexiform neurofibromas, can cause frequent and significant pain and impact quality of life.
* Often, NF1-related pain is not well-controlled with medication and many of the medications cause significant side effects.
* To our knowledge, only one prior study (by our group) has examined the effectiveness of a psychological intervention for chronic pain in adolescents and young adults (AYA) with NF1.
* Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain.
* The goal of ACT is not to eliminate the person's pain, but to optimize the person's functioning despite their pain

OBJECTIVES:

-To compare pain interference mean score changes from baseline to 8 weeks between the ACT intervention group and the waitlist (WL) group.

ELIGIBILITY:

* Patients 16 - 59 years of age with a confirmed diagnosis of NF1 and greater than or equal to 1 plexiform neurofibroma (PN).
* The patient must obtain a mean score of 2.0 or higher or a score of 3 on three or more items on the Pain Interference Index, and report having pain that interferes with functioning for at least three months.
* The patient must have regular access to a computer or tablet with internet access.

DESIGN:

* This is a psychological intervention study to determine the potential benefit of ACT on pain interference, with patients randomized to the ACT intervention or a wait-list control group.
* Patients will come to the National Institutes of Health (NIH) for a 2-day visit (Time 1). After baseline assessments (questionnaires and ECG) are completed, participants in the ACT group will take part in two 2-hour ACT training sessions. At home, this group will receive weekly emails through week 8, and will participate in further ACT training/educational sessions via video chat at weeks 2, 4, and 6.
* All patients will return to the NIH at week 8 (Time 2) to complete follow-up questionnaires and ECG. At this time, the WL group will cross over and receive the ACT intervention (in-person sessions, weekly emails, and video chat sessions). All patients will complete questionnaires again from home six months following the completion of the intervention.
* To detect a change of .68 standard deviation on the primary outcome measure between the two groups at .80 power, 41 patients per group are needed.

Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain

Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain: A Phase III Clinical Trial

The authors will make the data, protocol, and statistical plan available upon request. Also share raw data per researchers request to access the IPD via the online platform Yale University Open Data Access (YODA).

Here is the number of participants with serious and non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Pain interference mean score changes were compared between the two groups from baseline to 8 weeks using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale.T-scores typically can range from 0 to 100, with "average" scores ranging from 41-59. No subscales are included in this measure. Higher scores indicate more pain interference (worse).

A two-way repeated-measures analysis of covariance (ANCOVA) was used to examine changes between groups from baseline to the 8-week follow-up.

Baseline to post-treatment changes in disease-related quality of life was assessed various aspects of quality of life using a subscale from the Pediatric Quality of Life Inventory (PedsQL) Neurofibromatosis Type 1 (NF) Module adult questionnaire which uses a 0-4 Likert scale (0= never, 4 = almost always). Physical Functioning (7 items; possible range 0-28) subscale was administered. Higher scores are worse. Mean scores are linearly transformed to a 0-100 scale, and then were compared to means and standard deviations of a normative group of patients with Neurofibromatosis Type 1.

Measure of Pain Acceptance pre- and post-treatment was assessed by the Chronic Pain Acceptance Questionnaire (CPAQ) to determine if participants can accept his or her pain. Participants answer 20 questions on a 0 (never true) to 6 (always true) rating scale, with higher scores indicating higher levels of acceptance. Scores are obtained on two subscales (Activities Engagement and Pain Willingness) and an Acceptance Total scale. Only the total score was analyzed for this study. Scores can range from 0 to 120, with higher scores indicating more acceptance (better).

Pre and post changes in disease-related pain severity and overall tumor pain was assessed using the Numeric Rating Scale - 11 (NRS-11). Two questions rate pain severity on a scale of 0 (no pain) to 10 (worst pain imaginable). For both questions, higher scores = more pain. The two questions are examined separately, there is no total score across items.

Baseline to post-treatment changes in disease-related quality of life, including Daily Activities was assessed using a subscale from the Pediatric Quality of Life Inventory (PedsQL) Neurofibromatosis Type 1 (NF) Module adult questionnaire which uses a 0-4 Likert scale (0= never, 4 = almost always). Daily Activities (12 items; possible range 0-48) subscale was administered. Higher scores are worse. Mean scores are linearly transformed to a 0-100 scale, and then were compared to means and standard deviations of a normative group of patients with Neurofibromatosis Type 1.

Pre and post changes in disease-related depression was assessed using the 20-item Center for Epidemiological Studies - Depression scale (CES-D). Participants rate symptoms they have experienced in the past week and items are scored on a 0 (rare or none of the time) to 3 (most of all of the time) scale. Individual responses yield scores on four subscales: depressive affect, positive affect, somatic activity, and interpersonal. A total depression score is obtained that can range from 0 to 60, with higher scores representing worse depressive symptoms.

Pre and post changes in disease-related pain-related anxiety was assessed by the Pain Anxiety Assessment Scale - 20 (PASS-20). Items are answered on a 6-point Likert scale with anchors of "never" and "always" which provides a total score and scores on four subscales for Cognitive Anxiety, Pain-related Fear, Escape and Avoidance, and Physiological Anxiety. We only examined the total score on this measure, which can range from 0 to 100; higher scores indicate more anxiety.

Pre and post changes in disease-related HRV was assessed using an electrocardiogram (EKG). An EKG records electrical signals from your heart. The EKG reading will occur for 5 minutes while the patient is lying down and measurements, including the standard deviation of the average NN (normal-to-normal) interval (SDANN) and the square root of the mean squared differences of successive NN intervals is recorded, resulting in a metric of parasympathetically mediated (high frequency) HRV in milliseconds.

The psychometric properties of the pain interference measure PROMIS was administered to assess pain interference. And adult (18-59 years) and pediatric (16 -17 years) questionnaire was administered to assess how pain interferes with sleep, mood, and leisure activities for instance. Items were formatted on 0-4 Likert scales (0 = Never, 4 = Almost Always) and transformed to T-scores. The PROMIS Pain Interference Scale takes less than 5 minutes to complete and is required of all participants. T-scores typically range from the 20s to 80s with a mean of 50 and standard deviation of 10 ("average" scores range from 40 - 60). No subscales are included in this measure. Higher scores indicate more pain interference (worse). The pediatric and adult versions are made to be parallel so we analyzed all participants together across ages. A two-way repeated-measures analysis of variance (ANOVA) was used to examine changes between groups from baseline to the 8-week follow-up.

Pre- and post-treatment pain interference was assessed using the 12-item Psychological Inflexibility in Pain Scale (PIPS). Participants rate their avoidance of activities because of their pain on a Likert scale of 1 (never true) to 7 (always true). Eight of the items are summed to yield a score on the Avoidance subscale, and four of the items are summed for the Fusion subscale. A total score also is obtained by summing all 12 items. We analyzed only the total score in this study, which can range from 12-84, with higher scores indicating more inflexibility (worse).

National Cancer Institute (NCI)

Per protocol - "adverse events occurring as a result of treatment for the underlying condition or medical treatment for pain will NOT be recorded or reported on this study."

2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats.

Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain.

1/Acceptance and Commitment Therapy (ACT) Group

Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)

Acceptance and Commitment Therapy (ACT): Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain.

2/Waitlist (WL) Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Staci M. Peron, Ph.D.

Analysis of covariance. Analyses for primary and secondary outcomes were two-tailed and alpha was set to 0.05. An a priori analysis suggested that, to detect a change of .68 standard deviation on the primary outcome measure between the two groups at .80 power, 41 patients per group would be needed.

Baseline

8 weeks

30/34 were analyzed in the Waitlist group because 2 participants were withdrawn from final analyses due to medical contraindications identified immediately after the post-intervention follow-up.

Mean Pain Interference Mean Score Change From Baseline to 8 Weeks Between the Acceptance and Commitment Therapy Intervention Group and the Waitlist Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer	NCT04869267	Lung Cancer Advanced Cancer	Acceptance and ... Usual care	18 Years -	Chinese University of Hong Kong
RCT of Acceptance and Commitment Therapy Versus Mindfulness-based Stress Reduction in Head and Neck Cancer	NCT04800419	Cancer of Head ...	Acceptance and ... Mindfulness-bas...	18 Years -	Universiti Sains Malaysia
Optimizing Quality of Life in Women Living With Metastatic Breast Cancer	NCT04374825	Metastatic Brea...	Acceptance and ... Cognitive Behav...	18 Years -	Northwestern University
Acceptance and Commitment Therapy in Tuberous Sclerosis Complex	NCT05867576	Tuberous Sclero...	Acceptance and ...	11 Years - 24 Years	University Hospitals Bristol and Weston NHS Foundation Trust
Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain	NCT02471339	Neurofibromatos... Plexiform Neuro...	Acceptance and ...	16 Years - 59 Years	National Institutes of Health Clinical Center (CC)
A Guided Internet-delivered Individually-tailored ACT-influenced CBT Intervention to Improve Psychosocial Outcomes in Breast Cancer	NCT03275727	Breast Neoplasm	iACT-BC	18 Years -	Linkoeping University
Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain	NCT02471339	Neurofibromatos... Plexiform Neuro...	Acceptance and ...	16 Years - 59 Years	National Institutes of Health Clinical Center (CC)
A Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients - a Randomised Clinical Trial	NCT05161312	Cancer, Breast Quality of Life Distress, Emoti...	iACT-BC: Oncovo...	18 Years - 80 Years	Babes-Bolyai University
Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer	NCT04869267	Lung Cancer Advanced Cancer	Acceptance and ... Usual care	18 Years -	Chinese University of Hong Kong
Optimizing Quality of Life in Women Living With Metastatic Breast Cancer	NCT04374825	Metastatic Brea...	Acceptance and ... Cognitive Behav...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for acceptance and commitment therapy (act)