Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

10 mg lenvatinib (1x10 mg lenvatinib capsule) with food

10 mg lenvatinib (1x10 mg lenvatinib capsule) without food

HOPE

Study Director

This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization. The Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and fasted/fed). In each period, subjects will receive a single capsule containing 10 mg lenvatinib either with or without a standard breakfast. There will be a 2-week washout between treatments.

E7080 Food Effect Study in Healthy Subjects

Eisai Inc.

Behaviors and Mental Disorders

All Conditions

Quality of Life

The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

Living with Hope Program

Wendy D Duggleby, PhD

Family caregivers of terminally ill persons describe hope as inner strength that will help them continue caregiving. Our research team has developed and pilot tested a Living with Hope Program (LWHP) for caregivers of family members with advanced cancer, with the goal of fostering hope and improving quality of life (www.usask.ca/nursing /research/livingwithhope). The caregivers involved in our pilot test found the LWHP easy to use and we found some evidence to suggest that the program may have increased their hope and improved their quality of life. We would like to further develop and test the LWHP by finding out more about how and how long it might work. We believe it will improve the quality of life of active and bereaved older rural women of persons with advanced cancer and may decrease the number of prescriptions and doctor visits over one year. Since rural women caring for persons with advanced cancer seem to have the least hope, we want to focus on them first before including other caregivers in our research. Two hundred rural women caring for a person with advanced cancer will be asked to take part in this study. Their feelings of control, loss and grief, quality of life and hope will be measured over a year. The numbers of time they visit their physician and how many prescriptions they have over the year will also be collected. This study will contribute to the refinement of a Living with Hope Program that may improve quality of life and personal health of older rural women caring for their spouse with advanced cancer and those who subsequently become bereaved.

1. Background: The research team has developed and pilot tested a Living with Hope Program (LWHP) for caregivers of family members with advanced cancer. The LWHP includes viewing an award winning Living with Hope video followed by writing a daily journal for two weeks. The pilot test findings suggested that the LWHP is an acceptable and feasible intervention for use by family caregivers. Although the LWHP shows promise in potentially increasing hope and quality of life, further testing and development is needed. Questions remain as to: a) what are the mechanisms through which the LWHP affects outcomes and b) how long it is effective?
2. Purpose: The overall purpose of this time series mixed method study is the further development and testing of the LWHP by:

   1. Determining the mechanisms of the LWHP by testing the LWHP conceptual model in which self-efficacy and loss and grief are hypothesized intervening variables for changes in hope, and subsequently quality of life among rural women caring for persons with advanced cancer. In the LWHP model we hypothesize that administration of the LWHP will improve self-efficacy and decrease feelings of loss and grief. This will lead to a positive influence on the proximal outcome of hope and the distal outcome of quality of life.
   2. Exploring the longitudinal effects of the LWHP on hope, quality of life and health services utilization among older rural women caring for spouses with advanced cancer. We want to determine if the LWHP has benefits beyond what was found in the pilot. The team will compare baseline scores of hope and quality of life to scores after the LWHP over time and health services utilization (one year prospective number of physician visits and prescriptions compared to the year before the LWHP). This study is unique, as it will follow caregivers over a one-year period. As approximately 50% of these caregivers will become bereaved one month after study enrolment; rather than dropping these caregivers from the study, the team felt that retaining these subjects would add to the understanding of hope, quality of life and health care utilization among caregivers by continuing to follow them through bereavement. Thus, patterns of hope, quality of life and health care services utilization will be delineated over time for active and bereaved caregivers.
3. Research Plan: Using a time-series embedded mixed method design, baseline measures were collected from 122 rural women caring for a person who has advanced cancer. Data collection began January 2009 in 4 sites: Saskatoon Cancer Agency, Alan Blair Cancer Agency, Sunrise Health Region and Regina/Qu'Appelle Health Region. Data collection in Alberta started July 2010 through Alberta Health Services Community Cancer Clinics, and in September 2010 through a mail out through the Alberta Cancer Registry. In January 2011 subjects were enrolled through a mail out through the Saskatchewan Cancer Registry. Subjects who consented to participate in the full study received the LWHP. Subjects were then post tested on the variables at 1 and 2 weeks, 3, 6 and 12 months. Journal entries were copied and transcribed.
4. Data Analysis: Path Analysis will be used to test the model post LWHP at 1 and 2 weeks. Two-factor ANCOVA will determine patterns over time and Cortazzi's narrative analysis will be used to analyze the subjects journals completed as part of the LWHP.
5. Significance: This study will contribute to the refinement of the Living with Hope Program that may improve quality of life and personal health of older rural women caring for their spouse with advanced cancer and those who subsequently become bereaved. The findings will also increase our understanding of the factors influencing hope, quality of life and health in a vulnerable, understudied population that is increasing in numbers with the aging of Canada's population. Family care giving is what sustains patients at the end of life, and with changing demographics and diminishing resources there is a potential that every Canadian will be an informal caregiver at some time. Effective psychosocial supportive interventions, such as the LWHP are critical for their support and well-being.

Living With Hope Program for Rural Women Caregivers

Living With Hope: Developing a Psychosocial Supportive Program for Rural Older Women Caregivers of Spouses With Advanced Cancer

The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. These three subscales are consistent with descriptions of hope by caregivers in the preliminary work completed by the research team. The subscales also include measures of relationships and spirituality that are considered factors that influence hope. Summative scores range from 12-48, with a higher score denoting greater hope.

The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).

The scale consists of 10 items with responses from 1-4. The higher the Scores on the General Self Efficacy Scale (which has a range from 10 - 40), indicate higher participant feelings of self-efficacy. The General Self Efficacy Scale was chosen as a measure for this study because it has been found to be a reliable and valid measure in many populations.

The Non-Death Revised Grief Experience Inventory measures grief that is not associated with the death of a person. It is a 22-item scale measuring four domains (existential concerns, depression, tension and guilt, and physical distress) of the grief experience. Responses are scored on a 6-point scale, ranging from slight disagreement to strong agreement, with higher total score indicating more grief and loss. The Non-Death Revised Grief Experience Inventory has a minimum score of 22 and a maximum score of 132.

University of Saskatchewan

Professor

Living With Hope Program [Baseline]

Living With Hope Program [Day 7]

Living With Hope Program [Day 14]

Living With Hope Program [3 Months]

Living With Hope Program [6 Months]

Living With Hope Program [12 Months]

Living With Hope Program

Age, Continuous

Sex: Female, Male

Canada

Region of Enrollment

The Herth Hope Index provides a summative hope score and scores for three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. It is a 12 item likert response scale (1-4) with summative scores ranging from 12-48, with a higher score denoting greater hope. It has reported reliability (test-retest r=0. 91, p\<0. 05) and validity (concurrent validity, r=0. 84, p\<.0 05; criterion, r=. 92, p\< 0.05; divergent, r=-.73, p\<0. 05).

Herth Hope Index

This likert type scale has 10 items which produces a total perceived general self-efficacy score. Responses are made on a 4 point scale. Scores range from 10 to a maximum score of 40; the higher scores the higher participant feelings of self-efficacy. The GSES has been found to be a reliable and valid measure in many populations and countries and has been used in a study of hope and family caregivers of women with breast cancer. Reliability ranges from r=0.76 to r=0.90 and criterion related reliability was r=0.80, p\<0.05.

General Self-Efficacy Scale

The SF-12v2 was developed as a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF-12v2 produces a physical health component summary score (PCS), and a mental health component summary score (MCS), but not a total summary score. Scores range from 0 (poor health) to 100 (perfect health). The SF-12v2 physical summary and mental health summary scores correlate very highly (r=0.95 and 0.96 respectively) with the SF-36 and have reported test-retest reliability of r=0.89 and 0.76 respectively.

Short Form Health Survey Version 2 - Mental Health

Short Form Health Survey Version 2 - Physical Health

The NDRGEI is a 22-item scale measuring four domains of the grief experience for people who are not bereaved (item examples are in brackets): 1) existential concerns (e.g. "I feel lost and helpless"), 2) depression (e.g. "I cry easily"), 3) guilt (e.g. "I have feelings of guilt"), and 4) distress (e.g. "My arms and legs feel very heavy"). Responses are scored on a 6-point scale, ranging from slight disagreement to strong agreement, with a higher total score indicating more grief and loss. The Non-Death Revised Grief Experience Inventory has a minimum score of 22 and a maximum score of 132.

Non-Death Revised Grief Experience Inventory

Dr. Wendy Duggleby

Generalized estimating equations were used to determine change in patterns of the Herth Hope Index over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.

Generalized estimating equations were used to determine change in patterns of SF-12v2 Mental health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.

Day 7 Receive Living with Hope Program

Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

Day 14 Receive Living with Hope Program

Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

3 months Receive Living with Hope Program

Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

6 months Receive Living with Hope Program

Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

12 months Receive Living with Hope Program

Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

SF12 Mental Health

Generalized estimating equations were used to determine change in patterns of General Self Efficacy Scale scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.

Receive Living with Hope Program

Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

General Self-Efficacy Score (GSES)

Generalized estimating equations were used to determine change in patterns of Non Death Revised Grief Experience Inventory scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.

Generalized estimating equations were used to determine change in patterns of SF-12v2 Physical health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.

SF12: Physical Health

Overall Study

This group will receive the writing intervention.

Writing Intervention

The overall purpose of this study is to develop and pilot-test a theory-based psychosocial supportive "finding balance" intervention for older, bereaved spousal caregivers of a palliative cancer patient.

Research devoted to determining the efficacy of bereavement interventions remains a top priority. The development of theory-based, acceptable and feasible psychosocial interventions would begin to address the needs of family caregivers. A prominent theory of coping with bereavement, Stroebe and Schut's Dual Process Model, describes oscillation between loss-oriented and restoration-oriented coping; having a balance between these processes predicted more positive outcomes for older bereaved spouses. Similarly, the process of "finding balance" emerged as a first step in the search for new hope in the PI's grounded theory research with older bereaved family caregivers. They described the importance and difficulty of "finding balance" as they recovered from caregiving and struggled to find a new meaning and purpose for their lives after the loss of a spouse to cancer. An intervention focused on "finding balance" provides an innovative and promising approach to guiding the development of a theory-based psychosocial intervention for family caregivers who become bereaved. In clinical work a highly focused writing intervention has shown important benefits (personal communication, Dr. Robert Neimeyer, March 4, 2009). A validated tool to measure the effectiveness of an intervention to find balance does not exist, however valid existing measures of hope, grief, and an inventory of balance based on the Dual Process Model will be used as proxies. Therefore, the overall purpose of this study is to develop and pilot-test a theory-based psychosocial supportive "finding balance" intervention for older, bereaved spousal caregivers of a palliative cancer patient.

A Finding Balance Writing Intervention for Older Bereaved Caregivers

Finding Balance: The Experience of Hope for Bereaved Caregivers of Palliative Cancer Patients

Herth Hope Index, Hogan Grief Scale, Inventory of Daily Widowed Life, Finding Balance Scale

Saskatchewan Health Research Foundation

Associate Professor

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

None (observational study)

This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.

An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.

The Christie NHS Foundation Trust

University of Manchester

Honorary Consultant in Medical Oncology

Caregiver Burden

Explore Factors related to Truth Telling in Primary Caregivers of Children Newly Diagnosed with Cancer

Chen-Ni Li

SHIANN-TARNG JOU, PhD

The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.

Background: Over the last 50 years, telling truth in adult with cancer was direct. However, studies of truth telling in newly diagnosed children with cancer were seldom. Explore the factors and experiences related to truth telling in primary caregivers of children newly diagnosis with cancer were seldom too. Therefore, we could not estimate the current status of truth telling in primary caregivers of newly diagnosed children with cancer.

Purpose: The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.

Method: Purposive sampling structured questionnaire, used longitudinal resistance, repeated measurements, correlational design. SAS 9.3 for Windows was used for data entry and analyze. By using the frequency, percentage, mean, and standard deviation to describe demographic information and current status of truth telling. By using the mean, standard deviation, maximum and minimum to analyze hope, care burden, and quality of life. Demographic information, medical information data, truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Pearson correlation coefficients; the change and predictors about truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Generalized estimating equation.

Limitation: Studying in one medical center in Taipei, it could not estimate the country's primary caregivers of newly diagnosed children with cancer in conclusions. Because of the limitation of the manpower, time and case numbers, study tracked only six month, could not be assessed the long-term change of the Herth Hope Index, caregiver burden scale, truth telling and quality of life in primary caregivers of newly diagnosed children with cancer.

Factors Related to Truth Telling in Primary Caregivers

Explore Factors Related to Truth Telling in Primary Caregivers of Children Newly Diagnosed With Cancer

The scores of primary caregivers' Herth Hope Index change from baseline at family meeting at 3 months, and at 6 months.

We use Herth Hope Index(HHI) to evaluate the hope that the primary caregivers' care their child during treatment.

There are twelve questions in the Herth Hope Index. The total score is from 12 to 48. Cronbach's α is .89. Retest is .80. Two weeks retest is .86.

The higher the score is, the greater the hope is.

The scores of primary caregivers' quality of life index change from baseline at family meeting at 3 months, and at 6 months.

We use quality of life index(Q.L.I) to evaluate the quality of life that the primary caregivers' care their child during treatment.

There are 66 questions in the quality of life index. The total score is from 66 to 264. Cronbach's α is .95. Two weeks retest is .87.

The primary caregivers' truth telling change from baseline at family meeting at 3 months, and at 6 months.

Asking the primary caregivers' about that if you tell your child that he/she got the cancer, if you tell your child that he/she the treatment in future, and if you tell your child that he/she the rate of survival.

The scores of primary caregivers' care burden change from baseline at family meeting at 3 months, and at 6 months.

We use Questionnaire of care burden to evaluate the care burde that the primary caregivers' care their child during treatment.

There are 20 questions in the quality of life index. The total score is from 0 to 60. Cronbach's α is .91.

The higher the score is, the heavier the care burden is.

National Taiwan University Hospital

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

patients who will be under routine hospital care as well as Mindfulness-Based Stress Reduction (MBSR) program The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.

Female cancer patients who will be under routine hospital care

The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.

Mindfulness-based stress reduction intervention

Breast cancer is a significant issue in Egypt, affecting a large number of women and impacting their psychological well-being. Younger patients and those undergoing adjuvant therapy or radiotherapy are particularly susceptible to psychological distress. Psychological counseling and support groups can help improve patients' quality of life and social functioning. Hope plays a crucial role in the treatment process, as it is associated with positive outcomes and serves as a protective mechanism against stress and disease. Mindfulness-Based Stress Reduction (MBSR) is an intervention that can reduce stress and depression in cancer patients. It involves cultivating awareness of the present moment and has positive effects on quality of life. Investigating the impact of MBSR on psychological distress and hope in women undergoing radiotherapy for breast cancer is important for providing effective support during treatment.

The aim of this study is to:

Examine the effect of the Mindfulness-Based Stress reduction intervention on psychological distress and hope among female patients undergoing radiotherapy for breast cancer.

RESEARCH HYPOTHESIS Female patients undergoing radiotherapy for breast cancer who attend Mindfulness-Based Stress reduction intervention sessions exhibit higher levels of hope and lower levels of psychological distress compared to those who receive conventional hospital treatment.

Adult female patients with post-mastectomy to decrease the confounding factors.

Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer

Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer: A Randomized Control Trial

The Baer et al. (2006) scale is a 39-item questionnaire designed to measure different aspects of mindfulness. It uses a five-point Likert scale, with responses ranging from 1 (never or very rarely true) to 5 (very often or always true). The scale consists of five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.

Observing subscale: Measures the tendency to notice or attend to internal and external phenomena.

Describing subscale: Assesses the ability to label observed phenomena, such as thoughts and emotions.

Acting with awareness subscale: Reflects the extent to which individuals engage with full awareness in their current experience or activity.

Non-judging subscale: Assesses nonjudgmental awareness of current experience without evaluation.

Non-reactivity subscale: Measures the ability to notice internal phenomena without reacting to them.

It is a self-reported scale developed by Lovibond, \& Lovibond, (1995). The three subscales of the DASS 21 measure the negative emotional states of depression, anxiety, and stress (i.e., nervous tension and irritability, which are factorially distinct from depression and anxiety). Participants scored questions such as "I thought that as a person I wasn't worth much" (from "0" =did not apply to me at all to "3" =applied very much to me or most of the time). A total score out of 21 was determined for each subscale and then multiplied by 2 to be equivalent to the full-scale DASS scores. At least 10 (depression), 8 (anxiety), and 15 (stress) ratings indicated psychological distress levels for each item. Distress severity was categorized as mild, moderate, severe, and very severe.

The Herth Hope Index (HHI) is a clinical-setting adaptation form of the Herth Hope Scale (HHS). This scale was developed by Herth, at Minnesota State in the USA (Herth, 1992). It is composed of 12 items, which are rated on a four points Likert scale. The responses ranged from 1 (strongly disagree) to 4 (strongly agree). Items 3 and 6 are reversed in their score. The twelve items are summed to obtain a total score that ranges from 12 to 48, with a higher score equating to a higher level of hope. The instrument contains three factors, namely temporality \& future, positive readiness \& expectancy, and finally interconnectedness with self and others.

Alexandria University

Assistant professor at Psychiatric& Mental Health Nursing, Faculty of Nursing

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.

Acceptance and Commitment Therapy (ACT)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
E7080 Food Effect Study in Healthy Subjects	NCT01240408	Cancer	HOPE HOPE	18 Years - 55 Years	Eisai Inc.
Living With Hope Program for Rural Women Caregivers	NCT01081301	Advanced Cancer	Living with Hop...	18 Years -	University of Saskatchewan
A Finding Balance Writing Intervention for Older Bereaved Caregivers	NCT01416779	Grief	Writing Interve...	60 Years -	University of Saskatchewan
An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.	NCT03818230	Cancer Depression Anxiety Hope Psychological D...	None (observati...	18 Years -	University of Manchester
Factors Related to Truth Telling in Primary Caregivers	NCT02214446	Primary Caregiv...		20 Years -	National Taiwan University Hospital
Factors Related to Truth Telling in Primary Caregivers	NCT02214446	Primary Caregiv...		20 Years -	National Taiwan University Hospital
Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer	NCT06025799	Breast Cancer F...	Mindfulness-bas...	-	Alexandria University
Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer	NCT06025799	Breast Cancer F...	Mindfulness-bas...	-	Alexandria University
Factors Related to Truth Telling in Primary Caregivers	NCT02214446	Primary Caregiv...		20 Years -	National Taiwan University Hospital
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
A Finding Balance Writing Intervention for Older Bereaved Caregivers	NCT01416779	Grief	Writing Interve...	60 Years -	University of Saskatchewan
Living With Hope Program for Rural Women Caregivers	NCT01081301	Advanced Cancer	Living with Hop...	18 Years -	University of Saskatchewan
Living With Hope Program for Rural Women Caregivers	NCT01081301	Advanced Cancer	Living with Hop...	18 Years -	University of Saskatchewan

Spots Global Cancer Trial Database for hope

Every month we try and update this database with for hope cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hope

Every month we try and update this database with for hope cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hope cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.