Positive Psychology Intervention In HSCT

NCT05147311 | Completed Results DMC

• 2 other identifiers: 21-362K08CA251654
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Hematologic Malignancy; Hematopoietic/Lymphoid Cancer; Blood Cancer

Keywords

Hematopoietic Stem Cell Transplant; Positive Psychology; Hematologic Malignancy; Positive Psychological Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptability Rate

  9 weeks

• Mean Quality of Life Scores

  At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Other Outcomes (10)

• Mean Fatigue Score

  At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

• Mean Overall Physical Function Score

  At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

• Mean Anxiety Score

  At baseline (registration) and then week 9 (+/- 1 week) and week 18 (+/- 1 week) from the time of registration

Study Arms (2)

PATH Intervention

EXPERIMENTAL

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

Usual Care Control

NO INTERVENTION

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.

Interventions

Positive Psychology Intervention BEHAVIORAL

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.

PATH Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Amonoo HL, Lam JA, Daskalakis E, Deary EC, Celano C, Onyeaka HK, Newcomb R, Barata A, Horick N, Cutler C, Pirl WF, Lee SJ, Huffman JC, El-Jawahri A. Positive Psychological Well-Being in Hematopoietic Stem Cell Transplantation Survivors. Transplant Cell Ther. 2023 Sep;29(9):583.e1-583.e9. doi: 10.1016/j.jtct.2023.07.010. Epub 2023 Jul 11.

  PMID: 37442349 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Hermioni Amonoo, Director of Well-Being and Cancer Research Program
• Organization: Brigham and Women's Hospital

hermioni_amonoo@dfci.harvard.edu

‭(617) 525-7472‬

Study Officials

• Hermioni Amonoo, MD, MPP, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: November 17, 2021
• Primary Completion: May 16, 2023
• Study Completion: August 28, 2023
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact study investigator at hermioni\ amonoo@dfci.harvard.edu

Locations

US (1)