Online Health Support for Endometrial Cancer (RESILIENCE Trial)

N/A

Recruiting

Led By Carla Prado, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 16, and week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a web-platform with online healthcare support to improve health outcomes in endometrial cancer survivors.

Who is the study for?

This trial is for adults over 18 who've had low-grade, early-stage endometrial cancer and are 1-5 years post-surgery. They should have a BMI between 30 and 45, speak English, but not be pregnant or have metal implants that affect imaging tests. Those with eating disorders, recent weight changes, uncontrolled diabetes or thyroid issues, on certain medications, very active or on strict diets aren't eligible.

What is being tested?

The RESILIENCE trial is testing an online health platform called My Viva Plan along with professional support to see if it helps reduce waist size and improve health in survivors of endometrial cancer over a period of 24 weeks.

What are the potential side effects?

Since this intervention involves lifestyle changes supported by an online platform and healthcare professionals rather than medication or surgery, typical medical side effects are not expected. Participants may experience the usual risks associated with changing diet and exercise habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 16, and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 16, and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in waist circumference at week 16.

Secondary study objectives

Change from baseline in abdominal adiposity by MRI at week 24.

Change from baseline in abdominal skeletal muscle by MRI at week 24.

Change from baseline in adipose tissue in liver by MRI at week 24.

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment2 Interventions

Participants will receive the intervention for 24 weeks. The first 16 weeks will involve an intensive behavioral program (digital wellness platform plus online healthcare professional support), followed by an 8-week maintenance period (digital wellness platform alone). At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.

Group II: Control groupActive Control1 Intervention

At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.

Do I qualify?Apply below to find out