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

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

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Sleep; Allogenic Hematopoietic Cell Transplant
• Intervention / Treatment: Device: Fitbit; Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Eileen D Hacker, MD; Phone Number: 713-563-4004; Email: ehacker@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Eileen D Hacker, MD; Phone Number: 713-563-4004; Email: ehacker@mdanderson.org
      • Principal Investigator: Eileen D Hacker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire	You will answer questionnaires with a member of the research team. The questionnaires will take about 35 minutes complete. You will be asked questions about your sleep, anxiety and depressive symptoms, fatigue, distress, and your quality of life.	Through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Eileen D Hacker, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: August 22, 2025
• First Submitted That Met QC Criteria: August 22, 2025
• First Posted (Actual): August 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Motor Activity; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 2025-0317; NCI-2025-06207 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No