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

Hematopoietic Cell Transplantation Recipient Clinical Trial

Official title:

Feasibility of a Positive Psychology Intervention for Hematopoietic Cell Transplant Survivors to Improve Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525106
• Other study ID #: 9969
• Secondary ID: NCI-2018-0054199
• Status: Completed
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hematopoietic Cell Transplantation Recipient

Intervention

Behavioral:
• Booklet
Receive positive psychology manual
• Exercise Intervention
Complete positive psychology exercises

Other:
• Quality-of-Life Assessment
Ancillary studies
• Survey Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Participate in phone sessions

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study enrollment rates	The analysis of the study will mainly be descriptive. The proportion of participants who consent to enroll in the study will be computed based on the number approached through each method. Reasons for non-participation will be summarized. A larger randomized trial will be considered feasible if the enrollment rate for patients approached in person or over the phone is > 50% (excluding the active opt-out rate) and the overall completeness of follow-up data collection is > 70%, excluding patients who have died or are hospitalized/ill at the assessment point.; Since the number of caregivers who will participate is unknown, caregiver analyses will also be descriptive only.	Up to 8 weeks
Primary	Positive psychology intervention completion rates		Up to 8 weeks
Primary	Completeness of follow-up data collection	Completeness is defined by the proportion of instrument scores that can be calculated per given time point. The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales versus scales attempted to be collected or completed by patients.	Up to 8 weeks
Primary	Changes in happiness after each exercise	Change in happiness for each exercise will be analyzed by change scores. A change of 2 points on a 0-10 scale, with 10 being happiest, is considered clinically meaningful.	Baseline up to 8 weeks
Primary	Changes in optimism after each exercise	Change in optimism for each exercise will be analyzed by change scores. A change of 2 points on a 0-10 scale, with 10 being most optimistic, is considered clinically meaningful.	Baseline up to 8 weeks
Primary	Changes in mental health	This will be assessed with the patient-reported outcomes measurement information system, PROMIS-10 (Global-Mental). Higher scores are better. T scores will be used to standardize scores so that 50 represents the US general population and 10 is the standard deviation.	Baseline up to 6 months after intervention ends
Primary	Changes in physical health	This will be assessed with the patient-reported outcomes measurement information system, PROMIS-10 (Global-Physical). Higher scores are better. T scores will be used to standardize scores so that 50 represents the US general population and 10 is the standard deviation.	Baseline up to 6 months after intervention ends
Primary	Changes in fatigue	This will be assessed with the patient-reported outcomes measurement information system, PROMIS-Fatigue. Lower scores are better. T scores will be used to standardize scores so that 50 represents the US general population and 10 is the standard deviation.	Baseline up to 6 months after intervention ends
Primary	Changes in pain	This will be assessed with the patient-reported outcomes measurement information system, PROMIS-Pain interference. Lower scores are better. T scores will be used to standardize scores so that 50 represents the US general population and 10 is the standard deviation.	Baseline up to 6 months after intervention ends
Primary	Changes in resilience	This will be assessed with the Connor Davidson resilience scale. Total scores range from 0-40 with higher scores reflecting great resilience.	Baseline up to 6 months after intervention ends
Primary	Changes in anxiety and depression	The Hospital Anxiety and Depression Scale will be used to capture depression and anxiety. Scores on the Anxiety and Depression subscales range from 0-21 with higher scores indicating more distress. Subscales will be reported separately.	Baseline up to 6 months after intervention ends