BridgeMD
New treatment option for Endometrial Cancer
Official title ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial
ClinicalTrials.gov ID: NCT06038032
What this study is testing
- What it's testing
- RESILIENCE is 24-week randomized controlled trial that assesses the efficacy of a digital wellness platform, combined with online support from healthcare professionals, to enhance waist circumference and other vital health outcomes in endometrial cancer survivors.
- 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, women only. Healthy volunteers may be eligible.
You may be able to join if
- ≥ 18 years old
- Histologically confirmed endometrioid adenocarcinoma (low-grade), FIGO 2009 stages I to III.
- 1 month to 10 years post-surgery and completion of adjuvant treatment.
- BMI ≥25 and ≤45 kg/m2.
- Willing and able to adhere to the study interventions and assessments
You likely can't join if
- Recurrent (local, regional, or distant) or metastatic EC.
- Abnormal (i.e., mutated) p53 status in combination with FIGO 2009 stage III or IV
- Weight fluctuations (±5 kg) within the previous 3 months.
- Planned surgery in the next 6 months.
- Previous bariatric surgery.
- Uncontrolled thyroid disorder
See the full eligibility criteria
- ≥ 18 years old
- Histologically confirmed endometrioid adenocarcinoma (low-grade), FIGO 2009 stages I to III.
- 1 month to 10 years post-surgery and completion of adjuvant treatment.
- BMI ≥25 and ≤45 kg/m2.
- Willing and able to adhere to the study interventions and assessments
- Seeking best weight using the readiness to change questionnaire.
- Have a cell phone compatible with the Fitbit app with internet access and Bluetooth capabilities.
- Able to speak, read and understand English.
- Recurrent (local, regional, or distant) or metastatic EC.
- Abnormal (i.e., mutated) p53 status in combination with FIGO 2009 stage III or IV
- Weight fluctuations (±5 kg) within the previous 3 months.
- Planned surgery in the next 6 months.
- Previous bariatric surgery.
- Uncontrolled thyroid disorder
- Type 1 diabetes.
- Type 2 diabetes with HbA1c \> 10% or are taking insulin, sulfonylureas, or GLP-1 agonists.
- Taking corticosteroids.
- Taking anti-obesity drugs.
- Current smoker (of any type, e.g e-cigarettes, tobacco, marihuana, vaping)
- Self-report \>90 moderate-intensity min/week of aerobic physical activity on average over the past three months.
- Potential safety risk with exercise or maximal exercise testing screened with the 2023 Physical Activity Readiness Questionnaire (PAR-Q+)53, signs and symptoms of CVD, and any of the American Heart Association's...
- Physical or mobility limitations impacting ability to perform physical activity.
- Self-report following a structured hypocaloric diet (e.g., using formulated meal replacements, weight loss meal program) or a restrictive diet (intermittent fasting, or high-fat diet) in the past three months, or...
- Self-reported history of an eating disorder diagnosed by a physician.
- Intending to be away longer than 2 weeks consecutively during the intervention and unable to adhere to the study protocol during this period.
- Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs).
- Dual-energy x-ray absorptiometry (DXA) or magnetic resonance imaging (MRI) contraindications for research purposes, such as pacemakers or pregnancy
- Unable to participate in telephone and virtual intervention protocols (e.g., having a severe hearing or vision loss).
- Unable to adhere to the study protocol (i.e., unavailable to commit to scheduled group video conferencing sessions; limited access to the Internet; not willing to use platform, individuals who have been advised by a...
- Unable to come to study location.
- Unable to provide written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Toronto, Canada
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Toronto, Canada. 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.