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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Physical Activity; Allogenic Hematopoietic Cell Transplant; Sleep

Treatments: Other: Questionnaire; Device: Fitbit

Study type: Observational

Funder types: Other

Identifiers

NCT07140770

NCI-2025-06207 (Other Identifier)

2025-0317

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.