Clinical trial NCT03654404: A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
Official title: A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
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: Harvard Medical School (HMS and HSDM)
First posted: 2018-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: Hematopoietic stem cell transplantation (HSCT) is a rigorous treatment for blood cancer patients that can be life-saving, but often causes psychological distress. The investigators hope that this study will help the research team to develop and implement a positive psychological intervention designed to help HSCT patients increase positive emotions such as hope, gratitude, and fulfillment while recovering from a stem cell transplant. Participants will be selected after receiving an allogeneic hematopoietic stem cell transplant treatment in the past 30 days at the Dana-Farber Cancer Institute (DFCI).

In this project, the investigators hope to:

1. Test the feasibility and acceptability of a novel, 8-week, phone-based positive psychology intervention in a small cohort of post-HSCT patients (N = 20).
2. Explore potential benefits of completing the intervention on outcomes of interest, such as positive affect and overall function.

Baseline information about enrolled participants will be obtained from patients from the electronic medical record as required for characterization of our population. This information will include data regarding medical history, current medical variables, medications, and sociodemographic data.

Participants will be approached upon nearing their discharge from the hospital, approximately 30 days after their transplant. Between the time of their discharge and their 100-day post-transplant visit, there will be three check-in/psychosocial support phone calls at weeks 4, 8, and 12 after discharge to build rapport and discuss their recovery. Then, at week 14, participants will meet with the principal investigator to complete self-assessment questionnaires. The participants will then complete an 8-week phone-based positive psychology intervention, at the end of which the self-assessment questionnaires will be repeated.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of Positive Psychology (PP) Intervention
timeFrame: Baseline - week 8 of intervention
measure: Acceptability of Exercises: Ease Score
timeFrame: Baseline - week 8 of intervention
measure: Acceptability of Exercises: Utility Score
timeFrame: Baseline - week 8 of intervention
Secondary outcomes:
measure: Changes in PANAS Scores
timeFrame: Change in score from baseline to 8 weeks
measure: Changes in LOT-R Scores
timeFrame: Change in score from baseline to 8 weeks
measure: Changes in HADS Scores
timeFrame: Change in score from baseline to 8 weeks
measure: Changes in FACT-BMT Scores
timeFrame: Change in score from baseline to 8 weeks
measure: Changes in PROMIS-PF-20 Scores
timeFrame: Change in score from baseline to 8 weeks
measure: Immediate Impact of Exercises: Optimism Score
timeFrame: Week 1 of intervention - Week 8 of intervention
measure: Immediate Impact of Exercises: Positive Affect Score
timeFrame: Week 1 of intervention - Week 8 of intervention
Other outcomes:
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: