Development of a Positive Psychology Intervention to Improve Mood and HRQoL in Patients Post-HSCT - Proof of Concept



Status:Recruiting
Conditions:Cancer, Cancer, Blood Cancer, Blood Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:September 11, 2018
End Date:September 11, 2019
Contact:Hermioni Lokko, MD, MPP
Email:Hermioni_lokko@dfci.harvard.edu
Phone:617-732-4241

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Development of a Positive Psychology Intervention to Improve Mood and Health Related Quality of Life in Patients Post Hematopoietic Stem Cell Transplantation (PATH II)- Proof of Concept Trial

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.

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.

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
We found this trial at
1
site
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Hermioni Lokko, MD, MPP
Phone: 617-732-4241
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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