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Wearable tech aims to boost exercise and quality of life in cancer patients

NCT ID NCT06855706

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.