Physical ActivityNCT07140770
Sleep and Physical Activity in Patient and Caregiver Dyads Following Allogeneic Hematopoietic Cell Transplantation
An observational study of Physical Activity and Sleep, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To understand the changes in health-related quality of life of patients and caregivers after allogeneic hematopoietic cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity, Sleep, Allogenic Hematopoietic Cell Transplant
- What is being tested?
- Fitbit and Questionnaire
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To understand the changes in health-related quality of life of patients and caregivers after allogeneic hematopoietic cell transplantation.
Read the detailed description
Primary Objectives 2.1 Primary Objectives for the Entire Sample (N = 43 Dyads)
- 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.
2.1.1 Primary Objectives for Subgroup (n = 10 Dyads)
- Feasibility for the subgroup of 10 dyads will be determined by the percentage of patients and caregivers who wear the Fitbit for sleep and physical activity data from T3 to T4 (6week period after hospital discharge). For the purposes of this study, if ≥70% of patients and caregivers wear the Fitbit for 29 of 42 nights for sleep data and at least 10 hours during waking hours for 29 of 42 days for physical activity data at T4, the study will be determined to be feasible. Feasibility will be reported for patients and caregivers separately and will include the percentage of eligible participants who are approached, agree to participate, and complete research activities.
Secondary Objectives 2.2 Secondary Objectives for the Entire Sample (N = 43 Dyads)
- 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.
2.2.1 Secondary Objectives for Subgroup (n = 10 Dyads) 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 patients (n = 10) and their caregivers (n = 10) one week after hospital discharge (T3) and six weeks after hospital discharge (T4). • Hypothesis 1: HCT patients will demonstrate improvements 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 from T3 to T4, reflecting the expecting recovery. • Hypothesis 2: Caregivers will demonstrate increases in objectively measured sleep, physical activity, and frailty and participant-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, and cancer treatment distress from T3 to T4. 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 patients (n = 10) and their caregivers (n = 10) after discharge (T3) and six weeks after hospital discharge (T4). • Hypothesis: HCT patients 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 at T3 and no differences between groups at T4.
- Being tested
- Fitbit, Questionnaire
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitDevice
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.
QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start2 Sep 2025
- Primary completion11 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eileen D Hacker, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140770
- Sponsor's protocol ID
- 2025-0317
- Other IDs
- NCI-2025-06207
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Physical Activity in Patient and Caregiver Dyads Following Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT07140770
- Acronym / sponsor ID
- 2025-0317
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 11 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To understand the changes in health-related quality of life of patients and caregivers after allogeneic hematopoietic cell transplantation.
Detailed description
Primary Objectives 2.1 Primary Objectives for the Entire Sample (N = 43 Dyads)
- 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.
2.1.1 Primary Objectives for Subgroup (n = 10 Dyads)
- Feasibility for the subgroup of 10 dyads will be determined by the percentage of patients and caregivers who wear the Fitbit for sleep and physical activity data from T3 to T4 (6week period after hospital discharge). For the purposes of this study, if ≥70% of patients and caregivers wear the Fitbit for 29 of 42 nights for sleep data and at least 10 hours during waking hours for 29 of 42 days for physical activity data at T4, the study will be determined to be feasible. Feasibility will be reported for patients and caregivers separately and will include the percentage of eligible participants who are approached, agree to participate, and complete research activities.
Secondary Objectives 2.2 Secondary Objectives for the Entire Sample (N = 43 Dyads)
- 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.
2.2.1 Secondary Objectives for Subgroup (n = 10 Dyads) 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 patients (n = 10) and their caregivers (n = 10) one week after hospital discharge (T3) and six weeks after hospital discharge (T4). • Hypothesis 1: HCT patients will demonstrate improvements 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 from T3 to T4, reflecting the expecting recovery. • Hypothesis 2: Caregivers will demonstrate increases in objectively measured sleep, physical activity, and frailty and participant-reported sleep disturbance, sleep-related impairment, anxiety, depression, fatigue, and cancer treatment distress from T3 to T4. 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 patients (n = 10) and their caregivers (n = 10) after discharge (T3) and six weeks after hospital discharge (T4). • Hypothesis: HCT patients 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 at T3 and no differences between groups at T4.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitYou 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. | Device | – |
| QuestionnaireComplete 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. | Other | – |
Primary outcome
Quality of Life Questionnaire
Time frame: Through study completion; an average of 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen D Hacker, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Sleep, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.