Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Information of the breast cancer survivor period booklet

Women will be asked to use the app for at least 8 weeks. In order to monitor the usage, the researcher will monitor whether the women log in to the "Information and Counseling" section from the admin panel. Women who do not log in to the "Information and Counseling" section will be removed from the study at this stage. A weekly reminder will be sent to women via the mobile application. The questions asked by the participants through the question-and-answer section of the mobile health application will be examined every day and answered by the researcher between 10:00-11:00 every morning and 22:00-23:00 every evening. Likewise, the content shared by women in the forum section of the mobile application will be checked daily by the researcher and content that is harmful to women will be removed.

Mobile health application use

Women in the control group will be given information of the breast cancer survivor period booklet.

Serap ALKAŞ, Research Assistant

Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Treatments are aimed at prolonging survival from breast cancer and enabling patients to live better. Women repeatedly experience many vital crises such as the diagnosis of cancer, the difficulties of the treatment process and the fear of recurrence in the post-treatment period. In the face of these crises, post-traumatic growth occurs when the individual's efforts to cope are transformed into positive psychological experiences. Positive experiences lead to improvement in women's life, while negative experiences make it difficult to cope and adapt. In order for post-traumatic growth to take place, women should be supported to cope with these negative emotions. The care given to patients during cancer treatment should be such as to support the change process that will help individuals adapt to the new lifestyle.This information and supportive care content should include the topics that women will need in the long term after the treatment, in addition to the diagnosis and treatment process. Generally, the education and counseling given to the patient at the last treatment appointment may be limited. Due to the long period from the last treatment appointment to the control appointment, patients cannot interact with healthcare professionals for a long time. Long-term side effects and needs of people may differ after breast cancer treatment. For this reason, the need for information and consultancy services of healthcare professionals continues in this process as well.Today, the use of remotely accessible mechanisms in the treatment of breast cancer and in the follow-up of women after treatment is increasing. It is thought that the mobile application to be developed within the scope of the project will increase the quality and efficiency of health services with an R\&D and innovative approach and make these services accessible to everyone through digital technologies. In addition, our study will set an example for nursing care to be presented in one of the priority areas of health, such as cancer, through digital technologies. In our study, it is aimed to evaluate the effect of mobile health application based on Mezirow's Transformational Learning Theory on post-traumatic development in women with breast cancer. The research is a single center, parallel group, stratified block randomized controlled experimental study. It is planned to be conducted with 56 (intervention: 28, control: 28) women at Gazi University Health Research and Practice Center. The training content to be included in the mobile application has been determined by considering the results of the studies in the literature and the recommendations of international guides to determine the problems experienced by women with breast cancer during the post-treatment period. After receiving expert opinions on the subject content, the development process of the mobile application will be started. In the implementation phase of the study, the women in the intervention group will start using the mobile application 1 week after completing the active treatment chemotherapy and radiotherapy) process.The implementation of the study will last 8 weeks. At the end of eight weeks, data collection tools will be applied to the women. The final tests will be repeated 4 weeks after the end of the application. Starting from this period, women in the control group who want to use the application will also be included in the mobile application system. After completing the data collection tools, the analysis and reporting part will be started. Statistical analyzes will be made using SPSS Package Program (IBM SPSS Statistics 27). Student t test, Pearson Chi-square test, Independent Sample t test, Mann Whitney U test, One-Way Analysis of Variance or Friedman test will be used in the analyses.

In order to ensure similarity between the groups, stratified block randomization will be used to assign the women in the sample group to the experimental and control groups. In this method, after stratification according to risk factors, block randomization is performed within each stratum. Since the type of treatment applied in breast cancer and marital status will significantly affect posttraumatic development, stratification was made in terms of these parameters. Stratum 1 in terms of treatment type: Mastectomy, 2nd stratum: Breast conserving surgery or reconstructive surgery during mastectomy; Stratum 1 in terms of partner presence: Has a partner, Stratum 2: No partner. In order to determine which stratum group the women who were found to meet the research criteria and who agreed to participate in the study were in, blocks will be formed with a combination of 4 and the assignment list will be determined through the www.randomizer.org website.

The data obtained from the research will be coded as A and B by an independent researcher and transferred to the SPSS program. The data will also be analyzed by an independent statistician.

The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer

The Effect of Mobile Health Application Based on Transformational Learning Theory on Posttraumatic Growth in Women Diagnosed With Breast Cancer

Mean scores on the Grief Psychological Reactions to Loss of Health Scale Psychological Reactions Scale due to Loss of Health: The scale has 30 items and is a 5-point Likert type (1: never, 5: always). The scale does not have a total score. Evaluation is made according to the scores obtained from the sub-dimensions. It is seen that as the score obtained from the sub-dimensions increases, there is an increase in the number of people experiencing each of the stages of grief. The scale has two different evaluations and two different subscale ratings.

Post-Traumatic Development Scale in Cancer Patients: The scale consists of 23 Likert-type scale items scored between 0-5. It is evaluated between "0" (I have never experienced it) and "5" (I have experienced it a lot). The lowest score to be obtained from the scale is 0, the highest score is 115, and the higher the score obtained from the scale, the more the individual develops after the trauma.

Gazi University

Proffessor

Behaviors and Mental Disorders

Anxiety Disorders

Depressive Disorder

Depression

Head and Neck Neoplasms

Quality of Life

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.

Xinxiang medical university

Universiti Sains Malaysia

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Stomach Neoplasms

Lung Neoplasms

Colonic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Stomach Cancer

Providing tailored health care program, which provides various information related to exercise, diet, and posttraumatic growth.

Tailored health partnership program consists of three strategic areas (exercise, diet, and posttraumatic growth). Those areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model.

Patients who participate in the tailored health partnership program will be received tailored manual and workbook for tele-coaching that help them to lead their healthy life.

Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life.

Providing usual care. Also, patients will be provided a workshop for health education that is dealt with ten areas (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation).

Twelve month later, patients will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth.

When intervention group participate in the tailored program, they can receive various information which is related with three strategic areas (exercise, diet, and posttraumatic growth).

Three areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model.

Patients will be received tailored manual and workbook for health tele-coaching that help them to lead their healthy life.

The health tele-coaching will be operated sixteen times for 24 weeks. Intervention group will be provided three contents (exercise, diet, and posttraumatic growth) from health partners. The health partners took a certificate that is related with health, leadership and coaching.

Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. It will be proceeded for four hours. Three hours is for the leadership, and the last one hour is for presentation of their health mission statement.

Tailored health partnership program

While intervention group participate in the tailored health partnership program, control group can receive various information which is related with ten contents for health management (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). They will be provided a workshop and booklet for a health education for four hours.

Twelve month later, they will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth as same as the intervention group.

Usual care and health education workshop

YoungSung Lee, Ph.D

Jae Young Lim, PhD

Youngsung Lee, PhD

Ahreum Yoo, RN, BN

Borma Shin, BSW

Myungkyung Lee, Doctoral candidate

Mi Sun Chun, PhD

Chiheum Cho, PhD

KyungHae Jung, PhD

Soon Nam Lee, PhD

Eun Sook Lee, PhD

Siyoung Kim, PhD

Sung Kim, PhD

Young Ho Yun, PhD

Dong Young Noh, PhD

YoungSung Lee, MD, Ph.D

The Objectives of this study is

1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks
2. To evaluate the efficacy for quality of life, life satisfaction, health leadership, anxiety, depression, impact of event, social support, cancer belief as a result of participating in tailored program (Health Partnership Program) for 24 weeks
3. To assess the efficacy of such intervention compared with usual care in cancer patients

\*\*\*Background

Improving cancer patients' quality of life has been increasing subject of research for several years. Especially, the patients and their families who are needed to deal with specific care on diverse aspects, such as social, spiritual, existential, psychological aspect should be provided integrated program.

Multidimensional characteristics of the health partnership program were addressed in National Cancer Center (NCC) for exercise, diet, and posttraumatic growth based on transtheoretical (TTM) model, social cognitive theory, health behavioral model, and coaching strategies. This program points out the importance of behavioral approaches in managing their healthy life according to improve patterns of three areas (exercise, diet, and posttraumatic growth).

Strategies that investigators mentioned above can lead those three areas to be effective.

To objective of this study is to support cancer patients to cope with exercise, diet, and posttraumatic growth through tailored program (the health partnership program), and then evaluate the efficacy of the health partnership program.

From evidence extracted from a literature review, contents of the program was elaborated, and tailored from the TTM model. The curriculum is currently being reviewed and validated by expert group of oncologists, nurse, psychologist and health education scientists.

\*\*\*Method

To determine the efficacy of the program (the health partnership program), a randomized controlled trial will be conducted:

After excluding patients with other causes (anemia, thyroid disease, co morbidities etc), 248 patients will be recruited based on statistical assumption of alpha (0.05), beta (0.20=power 80%), and dropout rate (15%).

First, patients will be stratified according to their age, sex (male vs. female), cancer types (stomach cancer, Breast cancer, cervical cancer, colorectal (except rectal cancer) cancer, and lung cancer), and then allocated to an intervention or control group.

When intervention group participates in the tailored program (the health partnership program), they can receive various information which is related to health management and improving quality of life.

The health partnership program consists of 16 time's tele-coaching, a self leadership workshop, and providing health materials (manuals, workbook, and booklet). Especially, those will be dealt with managing three areas; exercise, diet, and posttraumatic growth based on the transtheoretical model (TTM), social cognitive theory, health behavioral model, and coaching strategies.

Cancer patients who are participated in the tailored program will be received tailored feedbacks that enhance participants of the next level of the program.

On the other hand, the control group could not participate in the health partnership program. The control group could only be treated by usual care and a health education workshop with a health booklet. However, the control group can participate in the health partnership program after 12 month.

Data will be collected before randomization, after intervention, and after a follow-up of 3, 6, and 12 months.

The Efficacy of Health Partnership Program for Cancer Patients

How much the patient does exercise will be measured using "MET" score. Change in diet will be observed by analyzing 3day recall.

Samsung Medical Center

Seoul National University Hospital

Korea University Anam Hospital

Asan Medical Center

Ajou University School of Medicine

Kyunghee University Medical Center

National Cancer Center, Korea

Head, Division of Cancer Management Branch

Wounds and Injuries

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Trauma and Stressor Related Disorders

Mental Disorders

Psychotic Disorders

The study will recruit from outpatient clinics with procedures designed to obtain a representative sample of research participants, in terms of diagnosis and time since diagnosis.

The study will first identify a large cohort of children who are willing to participate, and then call them back individually as they are found to match participants in the cancer group.

Sean Phipps, Ph.D

This proposal examines trauma and growth responses in the childhood cancer experience. It addresses a number of gaps and unanswered questions in the literature, while integrating several distinct but related lines of research. The rationale for this proposal is outlined briefly as follows:

1. Traumatic stress models focused on pathology dominate pediatric psychosocial oncology research despite empiric evidence of low levels of post-traumatic stress in this population.
2. The assumption of 'cancer as a traumatic event' has biased research designs (including lack of control comparisons) to focus on deficits and pathological outcomes.
3. This deficit-oriented approach has stimulated the development of interventions to treat or prevent PTSD, which may be unnecessary or even harmful.
4. Theoretical and empiric evidence suggests that a more common response to traumatic stress is growth and positive change, but posttraumatic growth phenomenon have been understudied in pediatric populations.
5. Cognitive and personality factors are important determinants of PTSD and positive growth outcomes, and some constructs from positive psychology theory may be particularly relevant in children with cancer.
6. Empirically, parents of children with cancer appear to be at higher risk of PTSD/PTSS, although results are not unequivocal, and the same research biases have applied to parental outcomes. This proposal includes assessment of parental PTSS and PTG, both as an outcome and a predictor of child outcomes.

This study examines the following outcomes:

1. To examine outcomes of posttraumatic growth and benefit finding (PTG) in children with cancer/cancer survivors in comparison to a population of children without history of serious illness.
2. To examine outcomes of posttraumatic stress (PTSS/PTSD) in children with cancer/cancer survivors in comparison to children without a history of serious illness.
3. To examine predictors of child posttraumatic stress and posttraumatic growth from medical variables, life events history, family environment, and child personality variables.
4. To apply an accelerated longitudinal design to examine trajectories of both pathological outcomes such as posttraumatic stress (PTSS) and positive outcomes such as challenge-related growth (CRG) in children with cancer/cancer survivors in comparison to a population of children without a history of serious illness. Additional observations will be obtained at 1-, 3-, and 5-years post study entry.
5. To examine outcomes of PTG and PTSS/PTSD in parents of children with cancer/cancer survivors in comparison to parents of healthy children. Parental PTSS/PTSD and PTG will be examined both as outcomes and as predictors of child outcomes.
6. To examine predictors of parent PTSS/PTSD and PTG from demographic and medical variables, life events history, and parent personality variables.
7. To determine the sensitivity/specificity of measures of PTSS in screening for PTSD based on diagnostic interview.
8. To examine the validity and reliability of a new measure of child personality, the Child and Adolescent Five Factor Inventory (CAFFI).
9. To examine emerging social developmental outcomes in this longitudinal cohort.
10. To develop an electronic version of the study measures and to compare data obtained electronically (on desktop or laptop computer), with data obtained on paper for comparability in reliability and outcomes obtained.

Stress, Adjustment And Growth In Children With Cancer And Their Parents

Use the Hemingway measure of social connectedness, and the Behavioral Assessment Scale for Children, 2nd Edition (BASC-2) by child, parent and teacher report.

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Regina A Jacob, MD

Posttraumatic Stress Disorder (PTSD) is a well-documented phenomenon that occurs in cancer survivors. PTSD is known to cause problems with anxiety, depression, and quality of life. Furthermore, there is little treatment available for cancer survivors who suffer from PTSD.

Posttraumatic Growth, however, is a lesser known phenomenon that also occurs in cancer survivors. It is a positive psychological phenomenon that occurs in some people who have suffered a traumatic event--the people who are able to note a "greater appreciation for life", a "stronger relationship with their family/friends," or a "new found level of spirituality" are examples of instances of posttraumatic growth.

Coping with Lymphoma to Enhance Adjustment and Reduce Stress in Survivors (CLEAR Stress) is a study designed to compare the development of PTSD versus the development of Posttraumatic Growth in lymphoma patients at any stage of the cancer experience, regardless of treatment. The hypothesis is that posttraumatic growth, if it is significant, can reduce the impact of PTSD symptoms in the survivor.

Longitudinal Survey Analysis in Lymphoma Survivors

Coping With Lymphoma to Enhance Adjustment and Reduce Stress in Lymphoma Survivors

Weill Medical College of Cornell University

Patients will be trained by pecha kucha method using computer with powepoint presentation.

Education with pecha kucha method

Zülfünaz Özer, PhD

Gülcan Bahçecioğlu Turan, PhD

Zülfünaz Özer

This study was planned to investigate the effect of the training given to breast cancer patients receiving chemotherapy with pecha kucha method on posttraumatic growth and psychological resilience.

This study is a randomized controlled trial planned to investigate the effect of the training given to breast cancer patients receiving chemotherapy with the pecha kucha method on posttraumatic growth and psychological resilience.

This study is an experimental study with pre-test and post-test control groups

Female breast cancer patients receiving chemotherapy

Pecha Kucha Method Effects on Posttraumatic Growth and Psychological Resilience

Education Given to Breast Cancer Patients Receiving Chemotherapy With Pecha Kucha Method Effects on Posttraumatic Growth and Psychological Resilience

The 6-point Likert-type scale consists of 21 items and a 5-factor structure and is scored between 0-5. The total score that can be obtained from the scale varies between 0-105. The sub-dimensions of the scale are relationships with others, new possibilities, personal empowerment, spiritual change and appreciation of life. High scores on the scale indicate that posttraumatic growth is high.

The 6-point Likert-type scale consists of 21 items and a 5-factor structure and is scored between 0-5. The total score that can be obtained from the scale varies between 0-105. The sub-dimensions of the scale are relationships with others, new possibilities, personal empowerment, spiritual change and appreciation of life. High scores on the scale indicate that posttraumatic growth is high.

Before the training

1 month after the training

The scale measures the psychological resilience of individuals. It is a 5-point Likert-type, 6-item, self-report measurement tool. High scores on the scale indicate high psychological resilience.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer	NCT06279806	Posttraumatic G... Grief	Mobile health a... Information of ...	-	Gazi University
The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer	NCT06279806	Posttraumatic G... Grief	Mobile health a... Information of ...	-	Gazi University
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
The Efficacy of Health Partnership Program for Cancer Patients	NCT01527409	Breast Cancer Colon Cancer Gastric Cancer Lung Cancer	Tailored health... Usual care and ...	20 Years -	National Cancer Center, Korea
Stress, Adjustment And Growth In Children With Cancer And Their Parents	NCT01044160	Posttraumatic G... Posttraumatic S...		3 Years - 25 Years	St. Jude Children's Research Hospital
Longitudinal Survey Analysis in Lymphoma Survivors	NCT01469754	Lymphoma Posttraumatic S... Posttraumatic G... Coping Resilience		18 Years -	Weill Medical College of Cornell University
Pecha Kucha Method Effects on Posttraumatic Growth and Psychological Resilience	NCT05836077	Posttraumatic G... Psychological R... Breast Cancer P...	Education with ...	18 Years - 80 Years	Istanbul Sabahattin Zaim University

Spots Global Cancer Trial Database for posttraumatic growth