Clinical trial NCT05147311: Positive Psychology Intervention In HSCT
Official title: Randomized Trial of a Positive Psychology Intervention for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Hematopoietic/Lymphoid Cancer
Blood Cancer
Keywords: Hematopoietic Stem Cell Transplant
Positive Psychology
Hematologic Malignancy
Positive Psychological Intervention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-12-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility Rate
timeFrame: 9 weeks
Secondary outcomes:
measure: Acceptability Rate
timeFrame: 9 weeks
measure: Mean Quality of Life Scores
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Other outcomes:
measure: Mean Fatigue Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Overall Physical Function Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Anxiety Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Depression Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Post-Traumatic Stress Disorder Checklist Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Optimism Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Positive Affect Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Satisfaction Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Gratitude Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
measure: Mean Flourishing Score
timeFrame: At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Hermioni Amonoo, MD, MPP, MPH
role: PRINCIPAL_INVESTIGATOR
References: