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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03525106
Other study ID # 9969
Secondary ID NCI-2018-0054199
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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