Positive Psychology Intervention to Improve Quality of Life in Stem Cell Transplant Survivors and Their Caregivers

NCT ID: NCT03525106

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2020-03-01

Brief Summary

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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

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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.

Conditions

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Hematopoietic Cell Transplantation Recipient

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Participants: Positive Psychology Intervention

Participants 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.

Group Type EXPERIMENTAL

Booklet

Intervention Type BEHAVIORAL

Receive positive psychology manual

Exercise Intervention

Intervention Type BEHAVIORAL

Complete positive psychology exercises

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Participate in phone sessions

Caregivers: Positive Psychology Intervention

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.

Group Type EXPERIMENTAL

Booklet

Intervention Type BEHAVIORAL

Receive positive psychology manual

Exercise Intervention

Intervention Type BEHAVIORAL

Complete positive psychology exercises

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Participate in phone sessions

Interventions

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Booklet

Receive positive psychology manual

Intervention Type BEHAVIORAL

Exercise Intervention

Complete positive psychology exercises

Intervention Type BEHAVIORAL

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Telephone-Based Intervention

Participate in phone sessions

Intervention Type BEHAVIORAL

Other Intervention Names

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Pamphlet Quality of Life Assessment

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Lee

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2018-00541

Identifier Type: REGISTRY

Identifier Source: secondary_id

9969

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9969

Identifier Type: -

Identifier Source: org_study_id

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