A trial looking at a support programme for men with prostate cancer (PRO-ACTIVE)

Coronavirus and cancer

We know it’s a worrying time for people with cancer, we have information to help. If you have symptoms of cancer contact your doctor.

Read our information about coronavirus and cancer

Cancer type:

Prostate cancer

Status:

Results

Phase:

Pilot

This trial looked at a support programme for men with prostate cancer who were having active surveillance.

Active surveillance involves monitoring the cancer and treating if it starts to grow.

This trial was for men with cancer inside the prostate gland that had a low or medium risk of coming back. It was open for them to join between 2015 and 2016 and reported in 2018. 

More about this trial

You might not need treatment straight away if your cancer is contained within the prostate gland. Your doctor may suggest active surveillance. 

Treatments for prostate cancer have side effects and some of these can be long term problems. So, if some men having active surveillance don’t ever need treatment, they avoid these side effects.
        
But active surveillance can be difficult to cope with. It can be worrying to have cancer, but not have treatment. We know from research that men on active surveillance experience 3 times as much anxiety as men without prostate cancer.  Some men may decide to go ahead with treatment before their cancer starts to grow. 

Doctors thought that providing the right support could help men cope better with active surveillance. And help to avoid unnecessary treatment in some men. 

The trial team developed a support programme called PROACTIVE. This stands for PROstate Cancer Support Intervention for ACTIVE Surveillance. The programme included workshops and online support sessions. 

The aims of this trial were to find out if men:

  • were willing to take part
  • took part fully in the support programme
     

Summary of results

The trial team found that the PROACTIVE support programme was acceptable to men who took part. But it didn’t work as well as researchers had hoped. So, they won’t be running a larger trial using the programme. 

About this trial
The researchers hoped to find 60 men to join this trial. But only 13 agreed to take part. 

This was a randomised trial.

  • 10 men took part in the support programme as well as having usual check ups with their consultant and GP.
  • 3 men had usual check ups with their consultant and GP (the control group).

Twice as many men joined the support programme group. 

The Support Programme Group involved:

  • group sessions run by a prostate cancer nurse specialist
  • online interactive sessions via the trial website

The group sessions covered different topics such as:

  • prostate cancer
  • diet and nutrition
  • exercise
  • thoughts and feelings 
  • relaxation techniques 

The online sessions covered some of the topics above, as well as practical issues such as money and work. 

The usual care group had routine check ups with the consultant and GP. At the end of the 12 months, they had full access to the trial website. This is the same website used by the other group when they took part in the online sessions.

Results
Researchers looked at what men thought about the support programme. They found that most found it acceptable. But they found 3 main problems. These were:

  • it was difficult to find enough men to join
  • men didn’t use the trial website as much as the researchers hoped
  • these men didn’t worry very much about their cancer 

Conclusion
The trial team concluded that the men who took part found it useful to share and discuss their experiences with others who had prostate cancer. But there were some problems with this small trial. 

So, the researchers decided that this support programme won’t be used in further research. But they say it might be worthwhile to further explore anxiety in men having active surveillance using a different trial design. But they don’t have any plans for this now. 

Where these results come from 
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) and accepted for publication in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
 

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor G. Lewith
Professor A. Richardson
Professor Geraldine M Leydon

Supported by

Prostate Cancer UK
Southampton University Hospital NHS Trust
University of Southampton

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13396

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think