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New treatment option for Endometrial Carcinoma
Official title An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study
ClinicalTrials.gov ID: NCT06855706
What this study is testing
- What it's testing
- This clinical trial compares the effect of an automated personalized physical activity intervention supported by wearable technology to standard of care on physical activity levels and quality of life in patients with stage II- IV ovarian, primary peritoneal, fallopian tube cancer or endometrial cancer that is newly diagnosed. Physical activity is a modifiable risk factor for the prevention and treatment of many diseases.
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have recurrent ovarian, primary peritoneal, or fallopian tube cancer at any time point of their recurrence, if they meet eligibility criteria (any...
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.