Clinical trial NCT03525106: Positive Psychology Intervention to Improve Quality of Life in Stem Cell Transplant Survivors and Their Caregivers
Official title: Feasibility of a Positive Psychology Intervention for Hematopoietic Cell Transplant Survivors to Improve Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Cell Transplantation Recipient
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies a positive psychology intervention designed to improve quality of life in stem cell transplant survivors and their caregivers. Positive psychology (PP) uses systematic exercises (e.g., gratitude letters, acts of kindness) to potentially boost levels of optimism, resilience, and life enjoyment. PP interventions are often enjoyable, easy to understand, and can be delivered via telephone. PP intervention may improve the quality of life of participants who have undergone a stem cell transplant or their caregivers.

Detailed description: PRIMARY OBJECTIVES:

I. Pilot a positive psychology intervention delivered to hematopoietic cell transplantation (HCT) survivors and interested caregivers over an 8 week period.

II. Determine the proportion of patients who enroll and the immediate benefit to participants, as measured by pre- and post-exercise measures of happiness and optimism.

III. Pilot outcome data collection mechanisms in preparation for a randomized clinical trial.

OUTLINE:

Participants and caregivers receive a positive psychology exercise manual, complete positive psychology exercises every week, and participate in phone sessions over 30 minutes every week for 8 weeks.

After completion of study, participants are followed up at 6 months.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* English as primary language
* At least 1 year after HCT

Exclusion Criteria:

* Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach.
* Medical conditions precluding participation in the intervention or likely to lead to death within 6 months, as determined by the principal investigator (PI)

Primary outcomes:
measure: Study enrollment rates
timeFrame: Up to 8 weeks
measure: Positive psychology intervention completion rates
timeFrame: Up to 8 weeks
measure: Completeness of follow-up data collection
timeFrame: Up to 8 weeks
measure: Changes in happiness after each exercise
timeFrame: Baseline up to 8 weeks
measure: Changes in optimism after each exercise
timeFrame: Baseline up to 8 weeks
measure: Changes in mental health
timeFrame: Baseline up to 6 months after intervention ends
measure: Changes in physical health
timeFrame: Baseline up to 6 months after intervention ends
measure: Changes in fatigue
timeFrame: Baseline up to 6 months after intervention ends
measure: Changes in pain
timeFrame: Baseline up to 6 months after intervention ends
measure: Changes in resilience
timeFrame: Baseline up to 6 months after intervention ends
measure: Changes in anxiety and depression
timeFrame: Baseline up to 6 months after intervention ends
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Stephanie Lee
role: PRINCIPAL_INVESTIGATOR
References: