Wearable tech aims to boost exercise and quality of life in cancer patients
NCT ID NCT06855706
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a personalized physical activity program using a wearable device (like a Fitbit) can help people with ovarian or endometrial cancer exercise more and improve their quality of life. About 120 participants will either receive tailored activity goals and feedback or standard exercise advice. The study also looks at how exercise affects the immune system and gut bacteria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized physical activity intervention via wearable device
- What this could lead to
- If successful, this could show that tailored activity goals help cancer patients exercise more and feel better, potentially improving immune function and daily life.
- What could go wrong
- This is a small, early-stage trial (120 participants) focused on feasibility and short-term outcomes. Results may not apply to all patients, and the intervention may not lead to lasting changes or clinical benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years old on day of signing informed consent * Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Participant must satisfy one of the following conditions: * Have a clinically suspected or confirmed diagnosis of stage II-IV ovarian, primary peritoneal, or fallopian tube cancer by clinical presentation and elevated CA-125 and may be awaiting staging surgery or tumor tissue biopsy followed by neoadjuvant chemotherapy. Inclusion of clinically suspected ovarian cancer cases is because we want to capture data starting from the earliest point of the diagnostic pathway and before definitive staging surgery. This allows us to assess the impact of physical activity and the feasibility of wearable device monitoring as patients transition into neoadjuvant chemotherapy and potential surgery * Have recurrent ovarian, primary peritoneal, or fallopian tube cancer at any time point of their recurrence, if they meet eligibility criteria (any histology accepted). Inclusion of recurrent ovarian cancer cases is because ovarian cancer often recurs, and understanding physical activity patterns and interventions in patients experiencing recurrence is critical for comprehensive insights. This ensures the study includes the continuum of disease management beyond initial diagnosis * Have pre-operative biopsy-proven endometrial cancer (endometrioid, serous, mucinous, or clear cell, poorly differentiated) with plans for surgical resection using a minimally invasive approach or medical management with chemotherapy combination, hormonal treatment or radiation. Inclusion of biopsy-proven endometrial cancer cases but not clinically suspected or recurrent cases is because we are focusing on confirmed, newly diagnosed patients who will undergo surgical resection or medical management * willing to wear the activity tracking device for at least 70% of their waking hours each day (11 hours/day) throughout the 6-month study period * under the care of Roswell Park Comprehensive Cancer Center during the study period, which includes one or more of the following: * Receiving cancer treatment at Roswell Park Comprehensive Cancer Center * Undergoing surgery at Roswell Park Comprehensive Cancer Center * Participating in surveillance visits at Roswell Park Comprehensive Cancer Center * Receiving adjuvant treatment at an outside facility but returning to Roswell Park Comprehensive Cancer Center for periodic consultation visits and agreeing to comply with all study procedures, including data sharing from external providers * willing to participate in questionnaires and blood and stool collection throughout the study for translational research purposes * Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure * Have a smartphone with daily internet access that is compatible with the wearable devices and applications used in the study (e.g., Fitbit Sense 2 and CGM applications) * NOTE: Patients who are already achieving or exceeding the goal of 150 minutes of physical activity per week are eligible for this study. This inclusion is intentional, as the study aims to evaluate the full spectrum of physical activity levels-both baseline activity and changes over time-and their relationship with clinical outcomes, metabolic measures (e.g., glucose levels), inflammation, and physical function Exclusion Criteria: * serious psychiatric illness that is not currently stabilized, including but not limited to: * Schizophrenia or other psychotic disorders * Bipolar disorder * Sever major depressive disorder * Severe personality disorders diagnosed by a qualified mental health professional * Recent suicide attempt or psychiatric hospitalization within the previous 12 months * Life expectancy of less than 12 months, as determined by the Investigator based on clinical judgment and available prognostic tools * history of other invasive malignancies within the last two years, except for: * Non-melanoma skin cancer * In situ cervical cancer * resting heart rate greater than 120 beats per minute after 10 minutes of seated rest, confirmed on two separate measurements * systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg, measured after 10 minutes of seated rest, confirmed on two separate measurements * Unstable angina or myocardial infarction within the past 3 months. * Unstable Angina: Chest pain at rest or chest pain of increasing frequency, severity, or duration that requires medical attention * Myocardial Infarction: Heart attack diagnosed by a medical professional * Pregnant or nursing participants will be excluded, as confirmed via urine test during screening procedures. * unwilling or unable to follow the protocol requirements, including but not limited to: * Cognitive impairment that affects the ability to provide informed consent or comply with study procedures * Language barriers without access to adequate translation services * Lack of access to necessary technology (e.g., smartphones compatible with study devices) * Other factors that would prevent adherence to study protocols * Any condition which, in the Investigator's opinion, makes the patient unsuitable for participation in the study or may interfere with the patient's ability to comply with the study requirements or the safety of the patient. Conditions may include, but are not limited to: * Severe pulmonary disease * Uncontrolled metabolic disorders * Other significant medical conditions that pose a risk during increased physical activity * Participants who do not provide a valid cell phone number or do not consent to receive SMS messages from Fitabase for motivational and compliance monitoring purposes will be excluded from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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Other studies related to the condition(s) this trial covers.
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