PATH-3: Positive Psychology Intervention In HSCT

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05147311
Collaborator
National Cancer Institute (NCI) (NIH)
70
Enrollment
1
Location
2
Arms
38.5
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Positive Psychology Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Randomized Trial of a Positive Psychology Intervention for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Nov 17, 2021
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility Rate [Weekly after randomization, up to 9 weeks]

    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.

  2. Acceptability Rate [Weekly after randomization, up to 9 weeks]

    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.

Secondary Outcome Measures

  1. Mean Quality of Life Scores [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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.

Other Outcome Measures

  1. Mean Fatigue Score [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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.

  2. Mean Overall Function Score [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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.

  3. Mean Anxiety and Depression Score [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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.

  4. Mean Post Traumatic Stress Disorder Checklist [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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.

  5. Mean Optimism Score [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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.

  6. Mean Positive Affect Score [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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.

  7. Mean Social Support Score [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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

  8. Mean Coping Score [At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration]

    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.

  9. Mean Minutes of Light Activity per Day [At baseline (registration) and then week 9 and week 18 from the time of registration]

    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.

  10. Mean Sedentary Leisure Time per Day [At baseline (registration) and then week 9 and week 18 from the time of registration]

    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..

  11. Mean Immunosuppressant Adherence Rate [Weekly from baseline, up to 18 weeks]

    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.

  12. Mean Self-Reported Tacrolimus Adherence Score [At baseline (registration) and then week 9 and week 18 from the time of registration]

    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.

  13. Mean Satisfaction Score [At baseline (registration) and then week 9 and week 18 from the time of registration]

    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.

  14. Mean Gratitude Score [At baseline (registration) and then week 9 and week 18 from the time of registration]

    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.

  15. Mean Flourishing Score [At baseline (registration) and then week 9 and week 18 from the time of registration]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Dana Farber Cancer InstituteBostonMassachusettsUnited States02215

Sponsors and Collaborators

  • Dana-Farber Cancer Institute
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Hermioni Amonoo, MD, MPP, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hermioni Amonoo, MD, MPP, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT05147311
Other Study ID Numbers:
  • 21-362
  • K08CA251654-01
First Posted:
Dec 7, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hermioni Amonoo, MD, MPP, Principal Investigator, Dana-Farber Cancer Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022