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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611001024932
• Date of registration: 26/09/2011
• Prospective Registration: Yes
• Primary sponsor: Psycho-Oncology Cooperative Research Group (PoCoG)
• Public title: 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
• Scientific title: 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.
• Date of first enrolment: 05/04/2012
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12611001024932.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Prof Professor Phyllis Butow

• Name: Prof Professor Phyllis Butow

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Males

Health Condition(s) or Problem(s) studied

Public Health - Health promotion/education

Mental Health - Studies of normal psychology, cognitive function and behaviour

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.;
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.

Cancer - Prostate

Intervention(s)

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.

Primary Outcome(s)

Recruitment to the RAVES trial, based on the proportion of men given Decision Aid study packages who decide to participate in the RAVES trial.[At one month]

Secondary Outcome(s)

Retention of participants in the RAVES trial will also be assessed.[Six months]

Anxiety towards participating in the RAVES trial (TROG 08.03) using a 6-item short-form of the state scale of the State-Trait Anxiety Inventory (STAI).[Baseline, one month and six months.]

Decisional regret ) with the decision regarding RAVES clinical trial participation using the 5-item Decisional Regret Scale (DRS)[One month and six months.]

Participants' knowledge about clinical trials using:
a) an adapted form of an existing 7-item scale regarding general clinical trial knowledge;
b) an 11 item scale developed specifically to assess understanding the RAVES trial (TROG 08.03), as presented in the DA, and by the 14-item Quality of Informed Consent (QuIC) scale-Part B. The QuIC-B measures perceived (subjective) understanding of the RAVES clinical trial.[Baseline, one month and six months.]

Satisfaction and difficulties with decision-making measured using the validated Decisional Conflict Scale (DCS) - a 16-item scale designed to measure the amount of uncertainty a person has regarding a course of action and the factors contributing to the uncertainty.[One and six months]

Clinician confidence with information provision for the RAVES trial (TROG 08.03) including confidence in the amount, clarity and completeness of information provided to patients, the ability of the patients to be involved in decision making, and the patient's understanding, will be assessed using an adapted form of an existing 6-item scale.[Before patient recruitment begins and upon completion of the study.]

Attitudes towards participating in the RAVES trial (TROG 08.03) using an adapted 9-item version of the Multidimensional Measure of Informed Choice scale.[Baseline, one month and six months.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

The Royal Australian and New Zealand College of Radiologists (RANZCR)

Ethics review

Status: Approved
Approval date:
Contact:

Peter MacCallum Cancer Centre Ethics Review Committee

Status: Approved
Approval date:
Contact:

Sydney Adventist Hospital Human Research Ethics Committee

Status: Approved
Approval date:
Contact:

The Alfred Hospital Ethics Committee

Status: Not approved
Approval date:
Contact:

Sydney South West Area Health Service HREC (RPAH Zone) (EC00113)