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: Completed
• 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 interventions (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 graft-versus-host disease (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): 72
• 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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Rate	Feasibility was defined a >75% of enrolled participants in the PATH group completing at least 6 of the 9 positive psychology sessions.	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability Rate	At the end of each weekly intervention session, acceptability was measured with weekly ratings of ease and utility of each positive psychology exercise with a 10-point Likert scale (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise was calculated.	9 weeks
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. Each question is scored from 0 ("Not at all") to 4 ("Very Much"). Total Score range from 0 to 180. A higher score indicates better quality of life. 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

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 total score range is 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 Physical Function Score	A mean overall physical 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 1 to 5. The total score range is 0 to 100. Higher scores indicate better physical function. 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 Anxiety Score	The 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) was used to assess symptoms of anxiety in all study participants. The total score on the HADS-A subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression. The mean anxiety 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 Depression Score	The 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) was used to assess symptoms of depression. The HADS-D consists of a four-point item response. Scores on the HADS-D subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression. The mean 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 Score	The 17-item Post-Traumatic Stress Disorder Checklist (PCL) was used to assess symptoms of post-traumatic stress according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1-5. The total overall score range is 17 to 85. A higher score indicates higher levels of PTSD. 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 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. The total overall score range is 5 to 35. 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. Each item is scored from 1-5. The total score range is 0 to 50. Higher scores indicate greater positive and negative affect. 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 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 is scored from 1-7; the total score ranges from 5-35. 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 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 (+/- 1 week) and week 18 (+/- 1 week) 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 and purpose, and optimism; higher scores indicate having many psychological resources and strengths. Each item is scored from 1-7; the entire questionnaire is scored from 8-56. 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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Hermioni Amonoo, MD, MPP, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): August 28, 2023

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): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

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 (Memorial Sloan-Kettering Cancer Center IRB); K08CA251654 (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 study investigator at hermioni_amonoo@dfci.harvard.edu
• 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