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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

April 17, 2018

Completed

28 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed

3 days until next milestone

Study Start

First participant enrolled

May 18, 2018

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed

Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

April 17, 2018

Last Update Submit

March 2, 2020

Conditions

Hematopoietic Cell Transplantation Recipient

Outcome Measures

Primary Outcomes (11)

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

Study Arms (2)

Participants: Positive Psychology Intervention

EXPERIMENTAL

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: BookletBehavioral: Exercise InterventionOther: Quality-of-Life AssessmentOther: Survey AdministrationBehavioral: Telephone-Based Intervention

Caregivers: Positive Psychology Intervention

EXPERIMENTAL

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: BookletBehavioral: Exercise InterventionOther: Quality-of-Life AssessmentOther: Survey AdministrationBehavioral: Telephone-Based Intervention