A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients

NCT03654404 | Completed Results

• 1 other identifier: 18-225
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to find out if a novel phone-based positive psychology intervention that focuses on improving health behaviors and positive emotions can help improve mood, health related quality of life, and overall function in patients who have just undergone hematopoietic stem cell transplantation as part of blood cancer treatment.

Conditions

Hematologic Malignancy; Hematopoietic/Lymphoid Cancer; Blood Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of Positive Psychology (PP) Intervention

  Feasibility will be measured by examining the number of completed exercises.

  Baseline - week 8 of intervention

• Acceptability of Exercises: Ease Score

  Participants will provide ratings of ease of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = very difficult and 10 = very easy). Ratings from all 8 weeks were averaged.

  Baseline - week 8 of intervention

• Acceptability of Exercises: Utility Score

  Participants will provide ratings of utility of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not helpful and 10 = very helpful). Ratings from all 8 weeks were averaged.

  Baseline - week 8 of intervention

Secondary Outcomes (7)

• Changes in PANAS Scores

  Change in score from baseline to 8 weeks

• Changes in LOT-R Scores

  Change in score from baseline to 8 weeks

• Changes in HADS Scores

  Change in score from baseline to 8 weeks

• Changes in FACT-BMT Scores

  Change in score from baseline to 8 weeks

• Changes in PROMIS-PF-20 Scores

  Change in score from baseline to 8 weeks

Study Arms (1)

Positive Psychology

EXPERIMENTAL

Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment. At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.

Behavioral: Positive Psychology Intervention

Interventions

Positive Psychology Intervention BEHAVIORAL

Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.

Positive Psychology

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 with hematologic malignancies hospitalized for allogeneic HSCT at the DFCI inpatient units who are medically stable and appropriate for study approach
• Ability to speak, read and write English
• Access to a telephone

You may not qualify if:

• Current major depressive episode, bipolar disorder, psychosis or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI)
• Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study assessed via the Brief Interview for Mental Status (BIMS)
• Medical conditions precluding interviews

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Hermioni L. Amonoo, Director of Well-Being and Cancer Research Program
• Organization: Dana-Farber Cancer Institute

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: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Well-Being and Cancer Research Program

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: September 11, 2018
• Primary Completion: March 31, 2021
• Study Completion: July 31, 2021
• Last Updated: June 12, 2024
• Results First Posted: January 19, 2022

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)