NCT02719821

Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The goal of this project is to refine and evaluate the feasibility of a brief, behavioral intervention to improve the recovery following hematopoietic stem cell transplantation (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue, and depression after HSCT. If the intervention is feasible and acceptable to patients, a future study will test the effects in a larger trial, with the long-term goal of improving the care and quality of life of cancer survivors recovering from HSCT.

Detailed description

Details of the assessment strategy: Patient-reported outcomes: Participants will complete self-report measures prior to HSCT and 9 (mid-intervention) and 18 weeks (post-intervention) post-HSCT. The sleep disturbance, fatigue, and depression modules of the NIH Patient Reported Outcomes Measurement Information System (PROMIS) will be the primary outcomes. The investigators will compare performance with more established instruments the investigation team has previously used: Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), and the Inventory of Depression and Anxiety Symptoms (IDAS) depression subscale. Actigraphy: The Actiwatch-2 (Philips Respironics), a wrist-worn actigraphy device, will be used to objectively quantify circadian rest-activity patterns over a continuous 7-day period using 1-minute sampling epochs at three time points: prior to HSCT and 9 (mid-intervention) and 18 weeks (post-intervention) post-HSCT. The following indices will be calculated: mesor (mean activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and R-squared (robustness of the rhythm). Participants will complete a concurrent nightly sleep log, and traditional sleep parameters will be calculated from both the logs and actigraphy, including total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset (WASO), and sleep efficiency (SE). For daytime activity, calibration thresholds will be used to aggregate activity data into steps and minutes spent in sedentary, light, moderate, and vigorous activity

Conditions

• Hodgkin's Lymphoma
• Leukemia
• Lymphoid Leukemia
• Multiple Myeloma
• Myeloid Leukemia
• Non-hodgkin's Lymphoma
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral techniques	Learning behavioral techniques designed to improve nighttime sleep quality and daytime activity for approximately 45-60 minutes on three occasions. Device: Actiwatch-2 (Philips Respironics)

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-06-02
• Completion: 2017-06-02
• First posted: 2016-03-25
• Last updated: 2019-11-15

Locations

1 site across 1 country: United States