NCT07140770

Sleep and Physical Activity in Patient and Caregiver Dyads Following Allogeneic Hematopoietic Cell Transplantation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 66 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To understand the changes in health-related quality of life of patients and caregivers after allogeneic hematopoietic cell transplantation.

Detailed description

Primary Objectives * Assess the feasibility and acceptability of obtaining objective sleep and physical activity measures in participants receiving allogeneic HCT and their caregivers during hospitalization (T2), and after discharge (T3) using Fitbits. * Feasibility will be determined by the percentage of participants and caregivers who wear the Fitbit Inspire 3 for sleep and physical activity data at T2, and T3. For the purposes of this study, if ≥70% of participants and caregivers will wear the Fitbit for 5 of 7 nights for sleep data and at least 10 hours during waking hours for 5 of 7 days for physical activity data at both data collection periods, the study will be determined to be feasible. Feasibility will be reported for participants and caregivers separately and will include the percentage of eligible participants who are approached, agree to participate, and complete research activities. Secondary Objectives * Examine trends in objectively measured sleep, physical activity, and frailty, and participant-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, cancer treatment distress, and quality of life in allogeneic HCT participants and their caregivers during hospitalization (T2), and after discharge (T3). * Hypothesis 1: HCT participants will demonstrate improvements in objectively measured sleep, physical activity, and frailty, and participant-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, and cancer treatment distress from T2 to T3. * Compare objectively measured sleep and physical activity, and participant-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, cancer treatment distress, and quality of life between allogeneic HCT participants and their caregivers during hospitalization (T2), and after discharge (T3). * Hypothesis: HCT participants will demonstrate significant improvements compared to their caregivers in objectively measured sleep and physical activity, and patient-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, cancer treatment distress, and quality of life. * Acceptability will be assessed using an investigator-developed instrument, the Physical Activity and Sleep Tracker Acceptability Survey.

Conditions

• Physical Activity
• Sleep
• Allogenic Hematopoietic Cell Transplant

Interventions

Type	Name	Description
DEVICE	Fitbit	You will wear the tracker on your wrist like a watch and it will continuously (non-stop) monitor your activity, sleep, and heart rate. Functional testing will be completed with a research team member and will consist of 2 tests: testing your grip strength by having you squeeze a measuring device 3 times with your dominant hand and measuring how many minutes it takes for you to walk 15 feet.
OTHER	Questionnaire	Complete questionnaires at 3 timepoints, at the time of enrollment on the day of allogeneic hematopoietic cell transplantation, 8 days after allogeneic hematopoietic cell transplantation, and 7 days after hospital discharge.

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-04-01
• Completion: 2028-04-01
• First posted: 2025-08-26
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States