Positive Psychology Intervention In HSCT

Study Overview
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Brief Summary
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The main purpose of this research study is to determine if a positive psychology-based program in people who have received a stem cell transplant for blood cancer treatment is feasible and acceptable, and can help improve positive feelings, mood, quality of life, overall wellbeing and health. The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention (PATH), a novel 9-week phone-administered Positive psychological intervention (PPI).

Detailed Description
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Low levels of positive psychological well-being (PPWB) (e.g., optimism, positive affect) in allogeneic hematopoietic stem cell transplant (HSCT) recipients are common and have been associated with decreased quality of life, poorer immune response, and increased mortality. These poor health outcomes are likely mediated through deficits in health behaviors (e.g., medication adherence, physical activity), and indeed low PPWB has been prospectively associated with poorer adherence to diet, medication, and physical activity in other medical populations, independent of sociodemographic, medical comorbidity, and the ill effects of depression and anxiety. Positive psychological intervention s (PPIs) could be used to promote PPWB in the allogeneic transplant population. Despite the successful and effective use of PPIs in medical populations to reduce distress, increase quality of life, and promote health behaviors, PPI have never been tested in allogeneic recipients. -This a single center randomized trial of the PATH intervention versus usual care in patients with hematologic malignancies undergoing HSCT. The research study procedures include screening for eligibility: Participants will be randomized equally to the two arms using randomized permuted blocks of sizes two and four, with randomization stratified by presence/absence of GVHD. As allogeneic transplant recipients with GVHD have significantly different courses of recovery, QOL, and function post transplant. Participant will be randomized into either: The Positive psychology for Allogenic Transplantation of Hematopoietic stem cell intervention (PATH), a novel 9-week phone-administered Positive psychological intervention (PPI) or usual care. It is expected that about 70 people will take part in this research study. The National Institute of Health (NIH), National Cancer Institute (NCI) is supporting this research study by providing funding for the research

Official Title
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Randomized Trial of a Positive Psychology Intervention for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation

Conditions
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Hematologic Malignancy, Hematopoietic/Lymphoid Cancer, Blood Cancer

Intervention / Treatment
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* Behavioral: Positive Psychology Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (≥ 18 years) with hematologic malignancies who have received allogeneic HSCT at Dana Farber Cancer Institute who are approaching 100-day post-transplant milestone. Ability to speak, read and write English. Access to a telephone. Exclusion Criteria: Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study procedures assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS). Medical conditions precluding interviews. Patients undergoing HSCT for benign hematologic conditions. Patients undergoing outpatient HSCT. Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures. Patients who are unable to verbally consent or are not yet adults (including infants, children, teenagers), pregnant women, or prisoners.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PATH Intervention<br>Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. At approximately 100-days post-HSCT, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). -Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention. | Behavioral: Positive Psychology Intervention<br>* Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.<br>|
| No Intervention: Usual Care Control<br>Participants in the Usual Care Control arm will receive regular social work assessments as part of HSCT recovery and work does not focus on PPWB skill building or cognitive strategies. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility Rate | Proportion of patients completing at least 6 of the 9 positive psychology (PP) sessions, which are phone delivered in the interventional cohort. Positive psychology (PP) sessions are interventions that encourage patients to perform simple, enjoyable activities as well as encourage gratitude, strengths, and life purpose. | Weekly after randomization, up to 9 weeks | 
| Acceptability Rate | Mean combined score of post PP session survey for the interventional cohort. Immediately after the completion of the weekly session, participants will rate the ease of exercise completion, overall utility of the exercise, and current levels of positive affect (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated, and a mean score out of 10.0 will be calculated. | Weekly after randomization, up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Quality of Life Scores | 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) to assess quality of life (QOL) by cohort. The FACT-BMT consists of five subscales assessing well-being across four domains (physical, functional, emotional, social, and bone marrow transplant symptoms). Each question is scored from 0 (Not at all) to 4 (Very Much). The final score will be presented as a percentage, calculated by tallying the total score out of 180. A higher score coincides with a better quality of life. | At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic Stem Cell Transplant, Positive Psychology, Hematologic Malignancy, Positive Psychological Intervention