None listed
Conditions
Brief summary
The primary purpose of this trial is to develop and test a model of shared care follow-up for men with prostate cancer with the aim of reducing unmet needs and psychological distress. Who is it for? You may be eligible to join this trial if you are aged 18 years or over and have been diagnosed with prostate cancer for which you have completed surgery and / or radiotherapy with curative intent at Royal Perth Hospital and at Fremantle Hospital in Western Australia, within three weeks of study entry. You will also need to have a GP who agrees to participate in the trial. Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will receive usual care (in accordance with local hospital practice). Participants in the other group will receive shared care, whereby some of the routine hospital visits are replaced by GP visits over the 12 month follow-up period. The trial aims to test whether a shared care model of follow-up for prostate cancer may reduce rates of psychological distress and unmet psychosocial and psychosexual needs and improve satisfaction with care at lower cost compared to usual care.
Interventions
The study seeks to develop and test a model of shared care follow-up for men with prostate cancer that aims to reduce psychological distress and unmet needs. Participants will be randomised to receive either usual care (in accordance with local hospital practice) or Trial shared-care (the intervention arm) for routine follow-up of prostate cancer for a period of 12 months. Those in the usual care (CONTROL) arm will have hospital follow-up visits at 6 weeks (radiotherapy treatment group only),
The study seeks to develop and test a model of shared care follow-up for men with prostate cancer that aims to reduce psychological distress and unmet needs. Participants will be randomised to receive either usual care (in accordance with local hospital practice) or Trial shared-care (the intervention arm) for routine follow-up of prostate cancer for a period of 12 months. Those in the usual care (CONTROL) arm will have hospital follow-up visits at 6 weeks (radiotherapy treatment group only), 3 months, 6 months, 9 months, and 12 months following the completion of surgery and / or radiotherapy. Those in the Trial shared-care (INTERVENTION) arm will attend hospital follow-up visits at 6 weeks (radiotherapy treatment group only), 3 months, and 12 months and GP visits at 2 weeks, 6 months and 9 months following completion of surgery and / or radiotherapy. That is, two of the routine hospital visits will be replaced by GP visits and an additional GP visit at 2 weeks post-randomisation is also included to discuss the patient care plan and to establish common group about the model of shared care. PSA testing and physical examination (digital rectal examination, DRE) will be completed at the 3, 6, 9 and 12 month visits in both arms.
Sponsors
Primary Care Collaborative Cancer Clinical Trials Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pathologically confirmed diagnosis of prostate cancer. 2. Completed surgery and / or radiotherapy with curative intention within 3 weeks of study entry 3. Able to read and write English at a level sufficient to give informed consent and complete study procedures including written questionnaires without an interpreter. 4. Have a general practitioner who agrees to participate in the Trial.
Exclusion criteria
1. Suspicion or evidence of metatastic disease 2. Severe psychiatric or cognitive disorder, which in the opinion of the investigator would compromise participation in the study. 3. Treatment with palliative intent. 4. No general practitioner. 5. Patients with a pathologically confirmed diagnosis of prostate cancer with any of the following high risk features (cT3; PSA greater than 20; or Gleason score greater than or equal to 8) 6. Patients having androgen deprivation therapy following radiotherapy, irrespective or risk level
Outcome results
None listed