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A supportive care clinical trial - SC31

Optimizing the delivery of a web-based self-management program for people with prostate cancer and their caregivers
Disease Site
Supportive Care Clinical Trials
Trial Code
SC.31 ǀ NCT06363266
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of this study is to find out if we can better support people with prostate cancer and their primary caregivers using a web-based self-management program called TEMPO. This will be done by comparing the effect of the usual approach of supporting people with prostate cancer to the effect of the TEMPO program plus the usual approach on the day-to-day anxiety associated with a prostate cancer diagnosis and treatment, or supporting someone through it.

Why is this study important?

A prostate cancer diagnosis and treatment, or supporting someone through it, brings many challenges. Self-management support to address these challenges is rarely available in standard care. Without this support, many people with prostate cancer lack the tools or confidence to manage cancer-related challenges effectively. Caregivers, who play an essential role, also typically lack the information and training they need. The study aims to address this gap by providing resources to empower patients and caregivers with the knowledge and tools needed for daily cancer management.

Who can participate in this study?

This trial is for:

People with a prostate cancer diagnosis and:

  • treatment for prostate cancer (other than active surveillance) is scheduled to start, is ongoing, or has been received within the past 2 years
  • can nominate a caregiver willing to participate in the study
  • have at least moderate anxiety (if not, caregiver must have at least moderate anxiety)
  • be able to read English or French
  • have access to the internet

 

Caregivers of people with prostate cancer and:

  • are nominated by the person with prostate cancer as their primary support person
  • are the spouse, partner or other family member of the person with prostate cancer they support
  • have at least moderate anxiety, if the person with prostate cancer does not
  • be able to read English or French
  • have access to the internet

This trial is not for:

  • people who are hospitalized.
What are the risks?
  • If you choose to take part in this study, there is a risk that the TEMPO program may not be as good as other approaches for managing the challenges related to prostate cancer or lowering your anxiety. The TEMPO program includes encouragement of physical activity to manage prostate cancer challenges. Your muscles may feel sore after participating in physical activity.
What can I expect?
  • If you choose to take part in this study, you will be randomly placed in one of two groups. Depending on which group you are placed in, you will either get access to the TEMPO program soon afterwards, or you will be given access to the TEMPO program after 12 weeks if you still need support at that time.
  • As part of this study, you will be asked to complete a questionnaire at three different times, so that the researchers can understand how people with prostate cancer and their caregivers can better self-manage the challenges and anxiety related to cancer.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you. Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have. Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care. The SC.31 study is currently enrolling patients at centres in Canada. For a full list of participating centres please visit www.clinicaltrials.gov/study/NCT06363266.

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.