Positive Psychology Intervention In HSCT (PATH-3)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Hematopoietic/Lymphoid Cancer; Hematologic Malignancy; Blood Cancer
• Intervention / Treatment: Behavioral: Positive Psychology Intervention

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PATH Intervention; 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; 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.
No Intervention: Usual Care Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Fatigue Score	The Patient Reported Outcome Measurement Information System-Fatigue-8a (PROMIS-Fatigue-8a) questionnaire will be used to assess fatigue by cohort. The 8 item questionnaire is scored 0-5 for each item for a total of 0-40. A higher score indicates higher levels of fatigue. A mean score will be presented for each cohort.	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Mean Overall Function Score	A mean overall function score will be generated for each cohort using a 20-item Patient-Reported Outcomes Measurement Information System-Physical Function-20 (PROMIS-PF-20) with each item scored from 5 to 1 for a total of 100 possible points; higher scores indicate better physical function.	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Mean Anxiety and Depression Score	Hospital Anxiety and Depression Scale (HADS) to assess symptoms of depression and anxiety in all study participants. The HADS is a 14-item questionnaire (two 7-item subscales assessing depression and anxiety symptoms during the past week). The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression. The mean anxiety and depression score will be reported for each cohort.	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Mean Post Traumatic Stress Disorder Checklist	The mean score for post-traumatic stress disorder (PTSD) will be reported by cohort. It will be evaluated using the Post-Traumatic Stress Disorder Checklist (PCL) to assess symptoms of post-traumatic stress in patients. The PCL is a 17 item self-reported measure that evaluates symptoms of post-traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1-5 for a total of 185 potential points. A higher score indicates higher levels of PTSD.	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Mean Optimism Score	The 7-item Life Orientation Test-Revised (LOT-R) will be used to measure dispositional (trait) optimism. Each item is scored from 1-5 for a total of 35 points possible. Higher scores indicate greater optimism. A mean score will be reported for each cohort.	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Mean Positive Affect Score	The 10-item Positive and Negative Affect Schedule (PANAS) will be used to measure positive affect; higher scores indicate greater positive and negative affect. Each item is scored from 1-5 for a total of 50 points possible. A mean score will be reported for each cohort.	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Mean Social Support Score	The 26-item Social Support Effectiveness Questionnaire (SSEQ), a validated instrument used in oncological population, will be used to assess patients' perception of social support. A mean score will be reported for each cohort. Higher scores indicate more effective support. Full scale scores can range from 0 to 80. Items 1, 6, and 11 -- responses are scored: Very poor = 0, Poor = 1, Fair = 2, Good = 3, Excellent = 4 Items 2, 7, and 12 - responses are scored: Not at all = 4, a little bit = 3, moderately = 2, quite a bit = 1, extremely = 0 Items 3, 8, and 13 - responses are scored: Not at all = 0, a little bit = 1, moderately = 2, quite a bit = 3, extremely = 4 Items 4, 9, and 14 - responses are scored: Never = 4, rarely = 3, sometimes = 2, often = 1, always = 0 Items 5, 10, and 15 - responses are scored: Never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 Items 16 through 25 - responses are scored: Yes = 0, no = 2	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Mean Coping Score	The Brief Cope, a 28-item questionnaire will be used to assess 14 methods of coping (e.g., self-distraction, humor, denial) using a 4-point Likert scale. Each Item is scored from 1-4 for a total of 112 points possible, with a higher score indicating better coping. A mean score will be reported for each cohort.	At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Mean Minutes of Light Activity per Day	Minutes per day of light activity will be measured using the well-validated Actigraph GT3X+ accelerometer. It will be work for 7 days (at least 4) on the week it is given to the subject. Ten or more ours of recorded data per day for at least four days is the minimum requirement for each use. A mean score will be reported for each cohort.	At baseline (registration) and then week 9 and week 18 from the time of registration
Mean Sedentary Leisure Time per Day	Sedentary leisure time per day will be measured using the well-validated Actigraph GT3X+ accelerometer. It will be work for 7 days (at least 4) on the week it is given to the subject. Ten or more ours of recorded data per day for at least four days is the minimum requirement for each use A mean score will be reported for each cohort..	At baseline (registration) and then week 9 and week 18 from the time of registration
Mean Immunosuppressant Adherence Rate	Medication (specifically immunosuppressant, tacrolimus or sirolimus) adherence will be measured via the widely used electronic pill monitoring system, MEMS Caps to electronically monitor immunosuppressant adherence over the duration of the study. From the electronic health records and confirmed by patients, will determine immunosuppressant medication and dosing, and will calculate changes in adherence over time (% of medication correctly taken, by week and month), based on MEMS data. A mean percent will be given for each cohort.	Weekly from baseline, up to 18 weeks
Mean Self-Reported Tacrolimus Adherence Score	Self-reported adherence to Tacrolimus (an immunosuppressant medication which all allogeneic HSCT patients must take) will be measured using the Medication Adherence Reporting Scale (MARS-5). This is a 5 item questionnaire, each scored from 1-5. A higher score indicates a higher level of adherence to medication. The entire questionnaire is out of 20. A mean score will be reported for each cohort.	At baseline (registration) and then week 9 and week 18 from the time of registration
Mean Satisfaction Score	Satisfaction will be measured by Satisfaction with Life Scale (SWLS). This 5 item questionnaire will measure satisfaction with life; higher scores indicate greater satisfaction with life. Each item will be scored from 1-7; the entire questionnaire will be scored from 5-35. A mean score will be reported for each cohort.	At baseline (registration) and then week 9 and week 18 from the time of registration
Mean Gratitude Score	The 6-item Gratitude questionnaire (GQ-6) measures dispositional gratitude; higher scores indicate greater proneness to experience gratitude in daily life. Each item will be scored from 1-7; the entire questionnaire will be scored from 6-42. A mean score will be reported for each cohort.	At baseline (registration) and then week 9 and week 18 from the time of registration
Mean Flourishing Score	The 8-item Flourishing Scale measures a person's self-perceived success in critical areas such as engagement, relationships, self-esteem, meaning & purpose, and optimism; higher scores indicate many psychological resources and strengths. Each item will be scored from 1-7; the entire questionnaire will be scored from 8-56. A mean score will be reported for each cohort.	At baseline (registration) and then week 9 and week 18 from the time of registration

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Hermioni Amonoo, MD, MPP, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Anticipated): March 31, 2025
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hematopoietic Stem Cell Transplant; Positive Psychology; Hematologic Malignancy; Positive Psychological Intervention
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 21-362 (Other Identifier: Memorial Sloan-Kettering Cancer Center IRB); K08CA251654-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No