RecruitingNAINTERVENTIONAL

ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial

This study, called RESILIENCE, is a 24-week trial for women who have had womb cancer. We know that after treatment, some women are at a higher risk of heart problems, especially if they are overweight or have a larger waist. Eating well, being active, and managing stress are important, but can be hard to keep up. This study wants to see if using a special online program, along with support from health professionals, can help women make these healthy changes. It will check if this support leads to improvements in waist size and overall health. If you've had womb cancer and are looking for ways to boost your health, this study might be for you.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

148

Start

25 Mar 2024

Estimated completion

01 Mar 2028

Endometrial Cancer

What is this study about?

If you've had womb cancer (also known as endometrial cancer), you may be wondering what you can do to stay healthy in the long term. This is a really important question, as we know that after treatment for womb cancer, some women might have an increased risk of heart problems, especially if they are overweight or have a larger waist. Making healthy choices, like eating well, being active, and managing stress, can really help to lower these risks and improve your overall health.

However, it can be tricky to stick to healthy habits, especially after going through cancer treatment. That's where this study comes in. It's called RESILIENCE, and its main goal is to find out if a special online program, combined with guidance from healthcare experts, can help women who have had womb cancer to live healthier lives. This would include things like improving their diet, getting more physical activity, and learning ways to feel calmer and more mindful.

The study will last for 24 weeks and will compare two groups of women. One group will use the digital health platform with expert support, while the other group will get general health information to start. Everyone in the study will get some general health advice, supportive phone calls, and an activity tracker to help monitor their movement. We hope that the results of this study will help us find better ways to support women like you in staying healthy and well after womb cancer.

Key takeaways

This study helps women who have had womb cancer improve their health.
It uses an online tool and support from health experts.
The goal is to help with healthy eating, being active, and managing stress.
It lasts for 24 weeks and involves using an activity tracker.
Participants are placed into groups to compare different types of support.
Your medical care is not affected if you choose not to take part or leave the study.

Who may be eligible?

This study is looking for women who have had a certain type of womb cancer (specifically, low-grade endometrioid adenocarcinoma, stages I to III) and are between 1 month and 10 years past their surgery and any follow-up treatments. You'll need to be aged 18 or over. Your body mass index (BMI) should be between 25 and 45. To take part, you'll also need to be willing to follow the study's instructions and assessments, as well as show an interest in managing your weight and health.

You'll need a smartphone that can use the Fitbit app, has internet access, and Bluetooth. Being able to understand, speak, and read English is also important for participating. If you meet these general requirements, you might be a good fit for this study.

However, there are some reasons why you wouldn't be able to join. For example, if your cancer has come back or spread, or if you've recently had big changes in your weight. Other reasons include having certain health conditions like uncontrolled thyroid issues, specific types of diabetes, or an eating disorder. If you smoke, have physical limitations that stop you from being active, or are planning major surgery soon, you also wouldn't be able to take part. The study team will review all specific criteria carefully to make sure it's safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with a specific type of womb cancer (low-grade endometrioid adenocarcinoma, stages I-III)?
Is it between 1 month and 10 years since your surgery and follow-up treatments for womb cancer ended?
Do you have a smartphone that can use the Fitbit app, has internet, and Bluetooth?
Are you willing and able to follow the study instructions and assessments?
Do you not currently smoke (any type), and haven't had recent major weight changes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for a total of 24 weeks. You'll be placed into one of two groups by chance.

One group will use a special online health platform every day for the first 16 weeks, with support and guidance from healthcare professionals. For the last 8 weeks, you'll continue to use the platform on your own. The other group will first receive general health information that is publicly available. After the 24 weeks are over, this group will then get access to the digital health platform.

No matter which group you are in, everyone will receive general health advice and supportive phone calls from the study team. You will also be given an activity tracker (like a Fitbit) to wear, which will help to monitor how active you are. There are no medications involved in this study. You will have regular checks and assessments to see how you are doing, which will be explained to you in more detail before you join.

Potential risks and benefits

Taking part in this study might offer you several benefits, such as gaining access to a digital platform and healthcare professional support to help you improve your eating habits, increase your physical activity, and manage stress. These changes could lead to better overall health and a reduction in your waist circumference. As with any study involving physical activity, there's a small risk of discomfort or injury, but the activities will be designed to be safe, and you will be properly screened. You might also find that using new digital tools takes some getting used to. Remember, taking part in any research study is completely voluntary, and you are free to withdraw at any time without giving a reason, and it will not affect your usual medical care.

Locations (2)

University of Alberta
Verified postcode
Edmonton, Canada· Recruiting
University of Toronto
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'womb cancer'?

Womb cancer, or endometrial cancer, starts in the lining of the womb (uterus). This study is for a specific type of womb cancer that has been successfully treated.

What is a 'digital wellness platform'?

It's an online program or app that offers tools and information to help you manage your health, like tracking your food, activity, and mood, or providing advice on healthy living.

Will I have to pay to use the platform or get the activity tracker?

No, all aspects of your participation in the study, including the digital platform and the activity tracker, will be provided to you free of charge.

How much time will this study take up each week?

The time commitment will vary, but generally, it involves daily engagement with the digital platform for the first 16 weeks if you're in that group, along with some calls and wearing an activity tracker. Specific details will be explained by the study team.

What kind of support will I get from healthcare professionals?

You will receive online support and guidance from healthcare professionals, which could include advice on diet, exercise, and mindfulness, tailored to your needs within the study program.

How to find out more

Teresita Gormaz, MSc

resilience.trial@ualberta.ca 780-492-1151 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.