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

Study Overview
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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.

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

Conditions
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Hematopoietic Cell Transplantation Recipient

Intervention / Treatment
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* Behavioral: Booklet
* Behavioral: Exercise Intervention
* Other: Quality-of-Life Assessment
* Other: Survey Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants: Positive Psychology Intervention<br>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. | Behavioral: Booklet<br>* Receive positive psychology manual<br>* Other names: Pamphlet;Behavioral: Exercise Intervention<br>* Complete positive psychology exercises<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Participate in phone sessions<br>|
| Experimental: Caregivers: Positive Psychology Intervention<br>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. | Behavioral: Booklet<br>* Receive positive psychology manual<br>* Other names: Pamphlet;Behavioral: Exercise Intervention<br>* Complete positive psychology exercises<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Participate in phone sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Positive psychology intervention completion rates |  | Up to 8 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |