Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001035213
Ethics application status
Approved
Date submitted
26/11/2009
Date registered
4/12/2009
Date last updated
17/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving communication about treatment options for asymptomatic ovarian cancer patients with rising cancer antigen 125 (CA-125): A randomised controlled trial of a Decision Aid
Scientific title
In women with asymptomatic ovarian cancer and rising cancer antigen 125 (CA-125) levels, does the use of a Decision Aid increase satisfaction and reduce difficulties with decision-making when compared to a general information booklet? A randomised controlled trial.
Secondary ID [1] 287852 0
None
Universal Trial Number (UTN)
Trial acronym
CA-125 DA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Communication about treatment options and decision making for women with asymptomatic ovarian cancer and rising CA-125 levels. 252295 0
Condition category
Condition code
Cancer 252475 252475 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women with asymptomatic ovarian cancer and rising CA-125 levels will be randomised to receive either a Decision Aid (intervention group) or a Cancer Council NSW booklet called Understanding Ovarian Cancer (control group). The Decision Aid is a booklet containing clear written and graphical information about each of the main treatment options, as well as exercises to help with the process of weighing up the pros and cons of these options. Participation in the study involves filling out two questionnaires over a 4 month period. The study is expected to conclude in 2012.
Intervention code [1] 241611 0
Other interventions
Comparator / control treatment
Women in the control group will receive a Cancer Council NSW booklet called Understanding Ovarian Cancer, which contains general information about ovarian cancer.
Control group
Active

Outcomes
Primary outcome [1] 253350 0
The primary outcome measure for this study will be satisfaction and difficulties with decision-making, assessed using the validated Decisional Conflict Scale (DCS).
Timepoint [1] 253350 0
This will be assessed in a questionnaire that the women complete after they have both read the booklet and made a treatment decision. There is no specific time frame in which this must occur.
Secondary outcome [1] 262426 0
Information and Involvement Preferences will be assessed using an adapted form of the Cassileth Information Styles Questionnaire.
Timepoint [1] 262426 0
This will be assessed in a questionnaire that the women complete after they have both read the booklet and made a treatment decision. There is no specific time frame in which this must occur.
Secondary outcome [2] 262427 0
Anxiety levels will be assessed using a 6-item short-form of the state scale of the State-Trait Anxiety Inventory (STAI).
Timepoint [2] 262427 0
This will be assessed in a questionnaire that the women complete after they have both read the booklet and made a treatment decision. There is no specific time frame in which this must occur.
Secondary outcome [3] 262428 0
Knowledge scale: Understanding the costs and benefits of the treatment options will be assessed using a scale developed specifically for this study.
Timepoint [3] 262428 0
This will be assessed in a questionnaire that the women complete after they have both read the booklet and made a treatment decision. There is no specific time frame in which this must occur.
Secondary outcome [4] 262429 0
Feedback on the Decision Aid (for those in the intervention group)
Timepoint [4] 262429 0
This will be assessed in a questionnaire that the women complete after they have both read the booklet and made a treatment decision. There is no specific time frame in which this must occur.
Secondary outcome [5] 262430 0
Patient treatment preferences, assessed through a preference scale question for each option, with endpoints "do not prefer this option" and "strongly prefer this option".
Timepoint [5] 262430 0
This will be assessed in a questionnaire that the women complete after they have both read the booklet and made a treatment decision. There is no specific time frame in which this must occur.
Secondary outcome [6] 262431 0
Quality of life: Patients will be asked to rate their overall quality of life using the single-item Spitzer Uniscale.
Timepoint [6] 262431 0
This will be assessed in a questionnaire that the women complete after they have both read the booklet and made a treatment decision. There is no specific time frame in which this must occur. It will be reassessed in a follow up questionnaire 4 months later.
Secondary outcome [7] 262432 0
Decisional regret and satisfaction will be measured with the Decisional Regret Scale (DRS) and the Satisfaction with Decision (SWD) Scale respectively.
Timepoint [7] 262432 0
This will be assessed in a follow up questionnaire 4 months after women have read the booklet and made a treatment decision.

Eligibility
Key inclusion criteria
Women with a diagnosis of epithelial ovarian cancer, who have undergone tumour debulking / cyto-reductive surgery, have completed first-line chemotherapy, and are currently asymptomatic during follow-up with rising CA-125 levels.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who do not understand sufficient English to read the booklet and complete the questionnaires, have a concurrent psychiatric disorder or are cognitively impaired are not eligible for the 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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomised block design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
10/12/2008
Actual
28/09/2009
Date of last participant enrolment
Anticipated
Actual
5/10/2016
Date of last data collection
Anticipated
Actual
22/11/2016
Sample size
Target
178
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,NT,TAS

Funding & Sponsors
Funding source category [1] 256091 0
Government body
Name [1] 256091 0
Cancer Institute NSW
Country [1] 256091 0
Australia
Primary sponsor type
University
Name
Centre for Medical Psychology and Evidence-based Decision-making
Address
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 251434 0
Hospital
Name [1] 251434 0
Sydney Gynaecologic Oncology Group
Address [1] 251434 0
Sydney Cancer Centre
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country [1] 251434 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258181 0
Syndey South West Area Health Service (RPAH Zone)
Ethics committee address [1] 258181 0
Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 258181 0
Australia
Date submitted for ethics approval [1] 258181 0
Approval date [1] 258181 0
10/12/2008
Ethics approval number [1] 258181 0
HREC/08/RPAH/531

Summary
Brief summary
The purpose of this study is to investigate the efficacy of a decision aid (DA) for women with asymptomatic ovarian cancer and rising CA-125 levels after successful first-line treatment. Participants will be randomised to receive either the DA or a control booklet called "Understanding Ovarian Cancer”. All participants will complete an initial questionnaire when they first make their treatment decision, and a follow-up questionnaire 4 months later. It is anticipated that the DA will improve understanding of the treatment options, reduce decisional conflict, increase satisfaction with decision-making, and not increase anxiety, compared to the control booklet.
Trial website
Trial related presentations / publications
Anderson, C., Carter, J., Nattress, K., Beale, P., Philp, S., Harrison, J., Juraskova, I. (2011). "The Booklet Helped Me Not to Panic" A Pilot of a Decision Aid for Asymptomatic Women With Ovarian Cancer and With Rising CA-125 Levels. International Journal of Gynecological Cancer, 21(4), 737-743.

I Juraskova, A Fisher, H Gray, C Bonner, G Heruc, C Anderson, K Nattress, G Gard, J Carter, S Paramasivam. Making difficult decisions about further treatment in ovarian cancer: the development and evaluation of two decision aids. The 30th Scientific Meeting of the Australian Society of Gynaecologic Oncologists (ASGO), Penang, Malaysia, July, 2015 (Poster)
I Juraskova, C Bonner, G Heruc, C Anderson, K Nattress, & J Carter. To treat or not to treat: A new RCT helping asymptomatic ovarian cancer patients with rising CA-125 levels to understand and choose their preferred treatment option. The 35th Annual Scientific Meeting of the Clinical Oncological Society of Australia (COSA), Gold Coast, November 2009 (Poster)
Public notes

Contacts
Principal investigator
Name 30555 0
A/Prof Ilona Juraskova
Address 30555 0
The Lifehouse, Royal Prince Alfred Hospital (C39Z)

The University of Sydney

NSW 2006 Australia
Country 30555 0
Australia
Phone 30555 0
+61 2 9036 5275
Fax 30555 0
Email 30555 0
[email protected]
Contact person for public queries
Name 13802 0
Dr Ilona Juraskova
Address 13802 0
The Lifehouse, Royal Prince Alfred Hospital (C39Z)

The University of Sydney

NSW 2006 Australia
Country 13802 0
Australia
Phone 13802 0
+61 2 9036 5275
Fax 13802 0
+61 2 9036 5292
Email 13802 0
[email protected]
Contact person for scientific queries
Name 4730 0
Dr Ilona Juraskova
Address 4730 0
The Lifehouse, Royal Prince Alfred Hospital (C39Z)

The University of Sydney

NSW 2006 Australia
Country 4730 0
Australia
Phone 4730 0
+61 2 9036 5275
Fax 4730 0
+61 2 9036 5292
Email 4730 0
[email protected]

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