RecruitingNAINTERVENTIONAL

A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers

This study is about a program called TEMPO, designed for men with prostate cancer and their family caregivers. TEMPO is an online tool that combines coping skills training and a home exercise plan to help manage the physical and emotional challenges of cancer, especially anxiety. It's designed to be used without constant healthcare professional guidance. We want to see how effective TEMPO is and if offering a bit more guidance to some people makes it work even better. Participants will be split into groups; some will use TEMPO, others will just monitor their anxiety. After 12 weeks, those who need more support will get access to TEMPO or more help with it. The goal is to improve the health and well-being of both patients and their caregivers.

At a glance

Status

Recruiting

Phase

Sponsor

St. Mary's Research Center, Canada

Enrolment target

376

Start

01 May 2025

Estimated completion

31 Aug 2028

Cancer of the Prostate Anxiety

What is this study about?

Living with prostate cancer can bring many challenges, not just for the men themselves but also for their families and caregivers. These challenges, from dealing with the illness itself to managing treatment side effects, can often lead to a lot of worry and anxiety. We know that family members who support their loved ones often feel anxious too, and their important role can sometimes be overlooked.

To help with this, researchers have developed a special online program called TEMPO over the past eight years. TEMPO stands for Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. It's designed to give both men with prostate cancer and their caregivers tools and skills to cope with the physical and emotional sides of cancer. This program is unique because it supports both patients and caregivers at the same time, offering real-life coping strategies and easy home exercises. Many people who have used TEMPO before said it helped them communicate better, learn new coping skills, and stay more active.

Because doctors and nurses are very busy, TEMPO was created so you can use it mainly on your own, without needing regular check-ins with healthcare professionals. This study aims to find the best and most cost-effective way to offer TEMPO, ensuring it truly helps those who need it most. We'll be looking at whether TEMPO leads to better health outcomes and less anxiety for both patients and their caregivers.

Key takeaways

TEMPO is an online program for men with prostate cancer and their caregivers.
It helps manage cancer challenges, reduce anxiety, and improve physical activity.
The program is mainly self-guided, easing the burden on busy healthcare staff.
You and your caregiver will complete surveys and possibly use the TEMPO program for 12 weeks.
Taking part helps improve support for future patients and families.
You can stop participating at any time.

Who may be eligible?

To join this study, we are looking for adult men who have been diagnosed with prostate cancer. You should have either just started treatment within the last two years or be about to start it now (this doesn't include something called 'active surveillance'). You also need to feel at least moderately anxious, which we'll check with a simple assessment.

We also need you to have a family member or partner who is willing to act as your main caregiver and join the study with you. This caregiver must also be feeling anxious if you, the patient, aren't. Both the patient and the caregiver need to be able to read in English or French and have access to the internet, as the TEMPO program is online.

Sadly, you won't be able to take part if you or your caregiver are currently in hospital. Otherwise, if you meet these points, you might be a good fit for this important research.

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 an adult man with a prostate cancer diagnosis?
Did your prostate cancer treatment start within the last 2 years, or are you about to start it (not active surveillance)?
Are you feeling at least moderately anxious?
Do you have a family member or partner willing to be your caregiver and join the study?
Can both you and your caregiver read English or French?
Do both you and your caregiver have access to the internet?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you and your caregiver will first complete some online surveys. Then, you'll be randomly assigned to one of two groups for 12 weeks. One group will start using the TEMPO online program right away. The other group will simply monitor your anxiety levels during this time. After these 12 weeks, we'll check everyone's anxiety levels again.

If you're in the TEMPO group and still need more support, we might offer you some extra guidance from a non-healthcare professional. If you were in the group just monitoring your anxiety and now need more help, you'll then get access to the TEMPO program. Throughout the study, both you and your caregiver will complete regular online surveys to help us understand if TEMPO is helping to improve your health and well-being. The total duration of active participation, including follow-up surveys, will be a few months.

Potential risks and benefits

Taking part in this study may offer several potential benefits, such as learning new ways to cope with the challenges of prostate cancer, reducing anxiety, and improving physical activity through the TEMPO program. By participating, you will also be helping us understand how to better support other men with prostate cancer and their caregivers in the future. As with any study, there's a small chance you might find some of the questions in the surveys or the activities in the TEMPO program sometimes challenging or upsetting, though we aim to make it as supportive as possible. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

St Mary's Hospital Research Centre
Verified postcode
Montreal, Canada· Recruiting
St. Mary's Research Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is TEMPO?

TEMPO is an online program designed to help men with prostate cancer and their family caregivers manage the emotional and physical challenges of the illness, and reduce anxiety, using coping skills and exercise.

Who developed TEMPO?

TEMPO was developed by a team of researchers over eight years, working closely with men living with prostate cancer and their caregivers.

Will I need to see a doctor or nurse for this program?

No, TEMPO is designed to be largely self-guided, meaning you can use it on your own without needing regular appointments with doctors or nurses. Some people needing extra support might get guidance from a non-healthcare professional.

Can my family member join with me?

Yes, TEMPO is designed for both the patient and their primary caregiver to use together. Your caregiver will need to agree to participate too.

What happens after the 12 weeks?

After 12 weeks, we'll check your anxiety levels. If you were monitoring anxiety and still need help, you'll then get access to TEMPO. If you were already using TEMPO and need more support, you might be offered further guidance.

How to find out more

Sylvie Lambert, PhD

sylvie.lambert@mcgill.ca 514-398-3685 Official trial record

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