Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001024932
Ethics application status
Approved
Date submitted
5/09/2011
Date registered
26/09/2011
Date last updated
4/02/2014
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 262397 0
Nil
Universal Trial Number (UTN)
U1111-1122-2971
Trial acronym
RAVES-DA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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. 268103 0
Condition category
Condition code
Cancer 268246 268246 0 0
Prostate
Mental Health 268247 268247 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 271041 271041 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 266786 0
Treatment: Other
Comparator / control treatment
The comparator is 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. 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.
Control group
Active

Outcomes
Primary outcome [1] 269170 0
Recruitment to the RAVES trial, based on the proportion of men given Decision Aid study packages who decide to participate in the RAVES trial.
Timepoint [1] 269170 0
At one month
Secondary outcome [1] 287916 0
Retention of participants in the RAVES trial will also be assessed.
Timepoint [1] 287916 0
Six months
Secondary outcome [2] 287917 0
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.
Timepoint [2] 287917 0
One and six months
Secondary outcome [3] 287918 0
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.
Timepoint [3] 287918 0
Baseline, one month and six months.
Secondary outcome [4] 287919 0
Attitudes towards participating in the RAVES trial (TROG 08.03) using an adapted 9-item version of the Multidimensional Measure of Informed Choice scale.
Timepoint [4] 287919 0
Baseline, one month and six months.
Secondary outcome [5] 287920 0
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).
Timepoint [5] 287920 0
Baseline, one month and six months.
Secondary outcome [6] 287921 0
Decisional regret ) with the decision regarding RAVES clinical trial participation using the 5-item Decisional Regret Scale (DRS)
Timepoint [6] 287921 0
One month and six months.
Secondary outcome [7] 287922 0
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.
Timepoint [7] 287922 0
Before patient recruitment begins and upon completion of the study.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All centres participating in the RAVES trial (TROG 08.03) will be invited to participate in the RAVES-DA study. Potential participants will be identified by their urologist or radiation oncologist, who will introduce the RAVES trial (TROG 08.03) and the associated DA study. The recruiter will be provided with a box of pre-randomised study packages by the DA researchers, and after brief introduction of the study and use of an eligibility/ineligibility checklist, will give consecutive packages to interested men considering the RAVES trial, whilst remaining blinded to the allocation. The recruiter will record the ID from the front of the package and the man’s name and contact details on a form, which will be emailed securely to the DA researchers as a password protected document. The DA researchers will then call the participant to further explain the DA study, answer any questions, confirm consent to participate, and prompt return of the baseline questionnaire to the research team. Recruiters will also complete a fax sheet for men who decline, with the man’s initials and the reason for declining (if known).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by a statistician blinded to the identity of participants, using computer-generated random numbers at the Psycho-Oncology Cooperative Research Group (PoCoG), at the University of Sydney. Randomisation will be stratified by recruiter.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
5/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 4447 0
2065
Recruitment postcode(s) [2] 4448 0
3128
Recruitment postcode(s) [3] 4449 0
8006
Recruitment postcode(s) [4] 4450 0
3015
Recruitment postcode(s) [5] 4451 0
2145
Recruitment postcode(s) [6] 4452 0
2560
Recruitment postcode(s) [7] 4453 0
2170
Recruitment postcode(s) [8] 4454 0
2050
Recruitment postcode(s) [9] 4455 0
2076
Recruitment postcode(s) [10] 7733 0
2217 - Kogarah
Recruitment postcode(s) [11] 7734 0
3181 - Prahran
Recruitment postcode(s) [12] 7735 0
3144 - Malvern
Recruitment postcode(s) [13] 7736 0
2139 - Concord Repatriation Hospital
Recruitment outside Australia
Country [1] 3629 0
New Zealand
State/province [1] 3629 0
Waikato
Country [2] 5801 0
New Zealand
State/province [2] 5801 0
Wellington

Funding & Sponsors
Funding source category [1] 269798 0
Other Collaborative groups
Name [1] 269798 0
The Royal Australian and New Zealand College of Radiologists (RANZCR)
Country [1] 269798 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Psycho-Oncology Cooperative Research Group (PoCoG)
Address
PoCoG, Level 6 - North
Chris O'Brien Lifehouse Building (C39Z)
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 268832 0
None
Name [1] 268832 0
Address [1] 268832 0
Country [1] 268832 0
Other collaborator category [1] 252250 0
Other Collaborative groups
Name [1] 252250 0
Trans-Tasman Radiation Oncology Group (TROG)
Address [1] 252250 0
TROG Central Operations
Department of Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7, Hunter Region Mail Centre
NSW 2310 Australia
Country [1] 252250 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271760 0
Sydney South West Area Health Service HREC (RPAH Zone) (EC00113)
Ethics committee address [1] 271760 0
Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 271760 0
Australia
Date submitted for ethics approval [1] 271760 0
31/08/2011
Approval date [1] 271760 0
Ethics approval number [1] 271760 0
Ethics committee name [2] 290504 0
Sydney Adventist Hospital Human Research Ethics Committee
Ethics committee address [2] 290504 0
185 Fox Valley Rd
Wahroonga NSW 2076
Ethics committee country [2] 290504 0
Australia
Date submitted for ethics approval [2] 290504 0
Approval date [2] 290504 0
31/01/2012
Ethics approval number [2] 290504 0
2011-043
Ethics committee name [3] 290505 0
The Alfred Hospital Ethics Committee
Ethics committee address [3] 290505 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [3] 290505 0
Date submitted for ethics approval [3] 290505 0
Approval date [3] 290505 0
16/11/2012
Ethics approval number [3] 290505 0
265/12
Ethics committee name [4] 290506 0
Peter MacCallum Cancer Centre Ethics Review Committee
Ethics committee address [4] 290506 0
Locked Bag 1
A'Beckett St
Victoria 8006
Ethics committee country [4] 290506 0
Australia
Date submitted for ethics approval [4] 290506 0
Approval date [4] 290506 0
31/05/2012
Ethics approval number [4] 290506 0
11/80

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32753 0
Prof Phyllis Butow
Address 32753 0
PoCoG, Level 6 - North
Chris O'Brien Lifehouse Building (C39Z)
University of Sydney NSW 2006
Country 32753 0
Australia
Phone 32753 0
+61 2 9351 2859
Fax 32753 0
+61 2 9036 5292
Email 32753 0
[email protected]
Contact person for public queries
Name 16000 0
Professor Phyllis Butow
Address 16000 0
PoCoG, Level 6 - North
Chris O'Brien Lifehouse Building (C39Z)
University of Sydney NSW 2006
Country 16000 0
Australia
Phone 16000 0
+61 2 9351 2859
Fax 16000 0
+61 2 9036 5292
Email 16000 0
[email protected]
Contact person for scientific queries
Name 6928 0
Professor Phyllis Butow
Address 6928 0
PoCoG, Level 6 - North
Chris O'Brien Lifehouse Building (C39Z)
University of Sydney NSW 2006
Country 6928 0
Australia
Phone 6928 0
+61 2 9351 2859
Fax 6928 0
+61 2 9036 5292
Email 6928 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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