None listed
Conditions
Brief summary
This study is a prospective evaluation and follow up looking at the utility of a decision aid for patients considering participation in a RAVES (Radiotherapy - Adjuvant Versus Early Salvage) Prostate Cancer trial (NCT00860652; TROG 08.03). It will compare participants who receive the decision-aid with those who receive a notebook to write down personal thoughts in relation to rates of recruitment and decision-making outcomes. Clinical trials are crucial to determine the best possible care for patients. However, low accrual and retention rates slow the introduction of new treatments in health care. This study will assess whether a decision aid for participating in a clinical trial improves accrual and reduces dropout rates. This mechanism for standardising information delivery about trials may ease the pressure on health professionals and the health system and transform the process of gaining informed consent. Who is it for? You may be eligible for this study if you are 18 and above, male, and eligible to participate in RAVES (TROG 08.03), i.e. you have prostate cancer with positive margins and/or stage pT3 disease following radical prostatectomy. Trial details In this study you will receive either the RAVES Decision Aid (DA) including an evidence-based representation of risk of prostate cancer recurrence for men eligible for the trial, their treatment options, the rationale for trials in general and the RAVES trial in particular, or a blank notebook for participants to write personal notes. The materials (DA or notebook) will be randomly distributed to eligible participants by the urologists and radiation oncologists involved in this study at their initial consultation, and form part of a package that contains the patient information sheet, consent form and questionnaires. Each participant will be sent follow-up questionnaires at 1 month and 6 months after recruitment. Thus the duration of participation for individuals is about 6 months. Recruitment to the study will continue over a period of two years.
Interventions
The RAVES Decision Aid (DA) was developed in accordance with the International Patient Decision Aid Standards (IPDAS). The content was based on a literature review and consultation with experts, including urologists, radiation and medical oncologists, trialists, consumers and psycho-oncologists. The DA includes an evidence-based representation of risk of prostate cancer recurrence for men eligible for the trial, their treatment options, the rationale for trials in general and the RAVES trial in
The RAVES Decision Aid (DA) was developed in accordance with the International Patient Decision Aid Standards (IPDAS). The content was based on a literature review and consultation with experts, including urologists, radiation and medical oncologists, trialists, consumers and psycho-oncologists. The DA includes an evidence-based representation of risk of prostate cancer recurrence for men eligible for the trial, their treatment options, the rationale for trials in general and the RAVES trial in particular. A description of the trial treatment arms and procedures, the randomisation process, the potential benefits and costs of trial participation, and a summary of treatment the procedures and schedules on each arm of the trial are presented together with a set of values clarification exercises to help men weigh up the pros and cons of participation in light of their values and life situation. The materials (DA or notebook) will be randomly distributed to eligible participants by the urologists and radiation oncologists involved in this study at their initial consultation. The materials will be part of a package that contains the patient information sheet, consent form and questionnaires. Additional questionnaires will be sent 1 month and 6 months later. This study will recruit patients over a total period of two years.
Sponsors
Psycho-Oncology Cooperative Research Group (PoCoG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consenting men who are eligible to participate in RAVES (TROG 08.03): men with prostate cancer who have positive margins and/or stage pT3 disease following radical prostatectomy, aged over 18 years.
Exclusion criteria
Insufficient English to read the DA booklet and complete questionnaires, and severe psychiatric or cognitive disorders. Ineligibility to the RAVES trial implies exclusion to the DA study.
Outcome results
None listed