Hematopoietic Cell Transplantation Recipient
Conditions
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.
Detailed 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.
Interventions
BEHAVIORALBooklet
Receive positive psychology manual
BEHAVIORALExercise Intervention
Complete positive psychology exercises
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERSurvey Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Participate in phone sessions
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study enrollment rates | Up to 8 weeks | 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. |
| Positive psychology intervention completion rates | Up to 8 weeks | — |
| Completeness of follow-up data collection | Up to 8 weeks | 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. |
| Changes in happiness after each exercise | Baseline up to 8 weeks | 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. |
| Changes in optimism after each exercise | Baseline up to 8 weeks | 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. |
| Changes in mental health | Baseline up to 6 months after intervention ends | 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. |
| Changes in physical health | Baseline up to 6 months after intervention ends | 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. |
| Changes in fatigue | Baseline up to 6 months after intervention ends | 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. |
| Changes in pain | Baseline up to 6 months after intervention ends | 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. |
| Changes in resilience | Baseline up to 6 months after intervention ends | This will be assessed with the Connor Davidson resilience scale. Total scores range from 0-40 with higher scores reflecting great resilience. |
| Changes in anxiety and depression | Baseline up to 6 months after intervention ends | 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. |
Countries
United States
Outcome results
None listed