RecruitingPhase 3ACTRN12611001024932

Evaluating the Utility of a Patient Decision Aid for Prospective Participants in the Trans-Tasman Radiation Oncology Group Radiotherapy - Adjuvant Versus Early Salvage Prostate Cancer Trial

Prospectively evaluating, in high-risk prostate cancer patients, the utility of a patient decision aid for participation in the RAVES (Radiotherapy - Adjuvant Versus Early Salvage) trial (NCT00860652; TROG 08.03), compared to patients not receiving this intervention, in relation to rates of recruitment and decision-making outcomes.

Sponsor

Psycho-Oncology Cooperative Research Group (PoCoG)

Enrollment

150 participants

Start Date

Apr 5, 2012

Study Type

Interventional

Conditions

Decision-making for clinical trial participation in men with prostate cancer who have positive margins and/or pathologic stage T3 (pT3; cancer extending beyond the capsule of the prostate gland) disease following radical prostatectomy, aged over 18 years.

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.

Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a decision-support booklet (a "decision aid") helps men with prostate cancer make more informed choices about whether to join a clinical trial comparing two types of radiation therapy after prostate surgery. The decision aid contains information about the cancer, the treatment options, and what to expect from the trial. Researchers want to see if it increases the number of men who decide to participate and makes decision-making easier. You may be eligible if: - You are a male aged 18 or older - You have prostate cancer with positive surgical margins or stage pT3 disease after a radical prostatectomy (prostate removal surgery) - You are eligible to participate in the related radiation therapy trial (RAVES/TROG 08.03) You may NOT be eligible if: - You do not have sufficient English to read the booklet and answer questionnaires - You have severe psychiatric or cognitive difficulties Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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.

Locations(2)

Waikato, New Zealand

Wellington, New Zealand

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ACTRN12611001024932