Health TrialsbyHealthPanel

ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥ 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.

Self-reported BMI ≥25 and ≤45 kg/m2, or self-reported BMI ≥18.5 and ≤24.9 kg/m2 together with a cardiometabolic condition or waist circumference ≥80 cm. Cardiometabolic conditions are also self-reported and included type 2 diabetes, prediabetes, hypertension, dyslipidemia, coronary artery disease, and stroke among others.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital wellness platform

    Behavioral

    A digital wellness platform based on preventive self-care that contains tools to monitor nutrition, physical activity, and mental wellbeing will be accessed daily for 24 weeks.

  • Online healthcare professional support

    Behavioral

    Individual sessions with a registered dietitian, an exercise professional, and a mental health therapist for 16 weeks.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 2 interventions
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in waist circumference at week 16.

Waist circumference will be measured in centimeters (cm) using an inelastic tape at the level of the iliac crest at the end of normal expiration.

Time frame
Baseline to week 16

Secondary outcomes

1

Change from baseline in waist circumference at week 24.

Waist circumference will be measured in centimeters (cm) using an inelastic tape at the level of the iliac crest at the end of normal expiration.

Time frame
Baseline and week 24
2

Change from baseline in body weight (in kg) at weeks 16 and 24.

Weight will be measured in kilograms (kg) in triplicate following standardized procedures; average values will be used for analysis.

Time frame
Baseline, week 16, and week 24
3

Change from baseline in fat mass by DXA at weeks 16 and 24.

Percentage fat mass will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique.

Time frame
Baseline, week 16, and week 24
4

Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24.

Appendicular lean soft tissue will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique. Appendicular lean soft tissue will be adjusted for body weight.

Time frame
Baseline, week 16, and week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov
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