Tracking sleep and physical activity in allogeneic transplant patients and their caregivers

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

We will try using Fitbits to see if they can reliably track sleep and activity for adults undergoing allogeneic hematopoietic cell transplant and their primary caregivers during hospitalization and after discharge.

Quick facts

• Study type: Observational
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07140770 on ClinicalTrials.gov

What this trial studies

This observational study enrolls adult patient–caregiver dyads undergoing allogeneic hematopoietic cell transplantation and uses Fitbit Inspire 3 devices plus questionnaires to collect objective sleep and activity data during hospitalization (T2) and after discharge (T3). Feasibility is defined a priori as at least 70% of participants and caregivers wearing the Fitbit for sleep (≥5 of 7 nights) and activity (≥10 hours on ≥5 of 7 days) at both timepoints, and feasibility metrics will include approach and completion rates. Secondary outcomes track trends in frailty, sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, cancer-related distress, and quality of life for both patients and caregivers. Data will be reported separately for patients and caregivers to evaluate acceptability and patterns of change over time.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults scheduled for allogeneic HCT who can identify a nonprofessional primary caregiver and have a smartphone or tablet capable of running the Fitbit app.

Not a fit: People with diagnosed sleep apnea, cognitive impairment, paid professional caregivers, non-English speakers, or those without a compatible smartphone/tablet are not eligible and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, clinicians could use wearable data to monitor recovery and tailor supportive care for transplant patients and their caregivers.

How similar studies have performed: Prior wearable-device studies in cancer and transplant populations have demonstrated feasible data collection in many settings, but using Fitbit monitoring in allogeneic HCT patient–caregiver dyads remains relatively novel and exploratory.

Eligibility criteria

Eligibility Criteria

* Participants and caregivers ages 18 years and older.
* Participants diagnosed with a hematologic malignancy with a scheduled allogeneic HCT.
* Caregivers identified by participant as the primary caregiver.
* Participants and caregivers able to read, speak, and consent in English.
* Participants and caregivers able to understand and be willing to sign a written informed consent document.
* Participants and caregivers must have internet access via smart phone or tablet with the capacity to 1) download the Fitbit app and 2) complete study assessments with study

Exclusion Criteria

* Participant or caregiver unable to provide consent, such as cognitively impaired individuals
* Participant or caregiver with a diagnosis of sleep apnea.
* Primary caregiver is a paid professional, such as a live-in Registered Nurse.
* Participant has multiple caregivers and is unable to identify one primary caregiver.

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Eileen D Hacker, MD — M.D. Anderson Cancer Center
• Study coordinator: Eileen D Hacker, MD

Conditions: Physical Activity, Sleep, Allogenic Hematopoietic Cell Transplant