Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000358347
Ethics application status
Approved
Date submitted
10/07/2008
Date registered
25/07/2008
Date last updated
26/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of early intervention to improve sexual and couple functioning after prostate cancer: ProsCan for Couples
Scientific title
ProsCan for Couples: A randomised controlled trial of a couples-based sexuality intervention to improve adjustment to sexual changes following surgery for prostate cancer.
Secondary ID [1] 260066 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
ProsCan for Couples
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 3391 0
Sexuality and sexual dysfunction 3392 0
Couple sexual and psychosocial adjustment after treatment for localised prostate cancer 3393 0
Economic evaluation of the sexuality support intervention to determine its relative economic efficiency. 3394 0
Condition category
Condition code
Cancer 3439 3439 0 0
Prostate
Public Health 3440 3440 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sexuality intervention DVD plus 8 sessions of telephone support by peer support volunteers (ie peers who have previously been treated for prostate cancer); or Sexuality intervention DVD plus 8 telephone-based sessions of counselling by prostate cancer nurse counsellors. In each intervention condition telephone calls will begin immediately after randomisation to intervention group and will continue until 6 months post-surgery: two telephone support/counselling sessions will be conducted prior to the male participant's surgery for prostate cancer and six sessions following surgery. Each support/counselling call will be approximately 1 hour in duration. Both intervention conditions will also receive a package of supporting materials including tipsheets and worksheets and an evidence-based patient education booklet about sexual function after treatment that was written by the present research team and that has national endorsement by Andrology Australia. The patient materials will be sent to participants immediately after randomisation to the intervention conditions.
Intervention code [1] 3117 0
Behaviour
Intervention code [2] 3118 0
Other interventions
Comparator / control treatment
Usual care - consists of the man's standard medical management and a package containing an evidence-based patient education booklet about sexual function after treatment that was written by the present research team and that has national endorsement by Andrology Australia. Participants who are randomised to the Usual Care condition will receive the package of materials immediately after randomisation.
Control group
Active

Outcomes
Primary outcome [1] 4332 0
Primary outcome 1: Sexual function will be assessed through self-report measures
Timepoint [1] 4332 0
Baseline and at 3, 6 and 12 months after surgery
Primary outcome [2] 4333 0
Primary Outcome 2: Sexual Supportive Care Needs will be assessed through self-report measures
Timepoint [2] 4333 0
Baseline and at 3, 6 and 12 months after surgery
Primary outcome [3] 4334 0
Primary Outcome 3: Sexual Self-Confidence will be assessed through self-report measures
Timepoint [3] 4334 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [1] 7299 0
Secondary Outcome 1: Psychological Distress will be assessed through self-report measures
Timepoint [1] 7299 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [2] 7300 0
Secondary Outcome 2: Quality of Life will be assessed through self-report measures
Timepoint [2] 7300 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [3] 7301 0
Secondary Outcome 3: Cancer Specific Distress will be assessed through self-report measures
Timepoint [3] 7301 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [4] 7302 0
Secondary Outcome 4: Benefit Finding will be assessed through self-report measures
Timepoint [4] 7302 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [5] 7303 0
Secondary Outcome 5: Masculine Self-Esteem will be assessed through self-report measures
Timepoint [5] 7303 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [6] 7304 0
Secondary Outcome 6: Utilisation of Sexual Aids will be assessed through self-report measures
Timepoint [6] 7304 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [7] 7305 0
Secondary Outcome 7: Sexual Self-Efficacy will be assessed through self-report measures
Timepoint [7] 7305 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [8] 7306 0
Secondary Outcome 8: Marital Satisfaction will be assessed through self-report measures
Timepoint [8] 7306 0
Baseline and at 3, 6 and 12 months after surgery
Secondary outcome [9] 7502 0
Secondary Outcome 9: Economic Evaluation will be assessed through (1) self-report measures associated with out-of-pocket expenses, disruption to work; (2) Medicare Australia data on medical and other health-related expenses; and (3) organisational expenses associated with implementation of the intervention.
Timepoint [9] 7502 0
Baseline and at 3, 6 and 12 months after surgery.

Eligibility
Key inclusion criteria
Patients/couples must be newly diagnosed with localised prostate cancer, chosen radical prostatectomy as treatment, be in a heterosexual relationship, living with partner, no previous head injury or dementia, able to read and write English, not undergoing treatment for another cancer, not receiving current psychological or psychiatric care, score 80 or more on the Dyadic Adjustment Scale
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients/couples with prostate cancer recurrence or progression, advanced prostate cancer, chosen treatment apart from radical prostatectomy, in homosexual couple relationship, partners living apart, previous head injury or dementia, unable to read and write English, undergoing treatment for another cancer, currently receiving psychological or psychiatric care, scored less than 80 on the Dydadic Adjustment Scale.

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)
Suitable participants will be identified by clinicians/hospital staff and referred to the study team. After participants have provided informed consent baseline data will be collected. Eligibility for participation in the trial of the sexuality intervention will then be determined. For eligible participants, allocation concealment will occur, with randomisation being undertaken by the holder of the allocation schedule who is based at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer generated table.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Three group randomised controlled trial: nurse delivered counselling plus DVD; peer support plus DVD; usual care
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2008
Actual
25/07/2009
Date of last participant enrolment
Anticipated
Actual
13/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
420
Accrual to date
Final
378
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 3579 0
Government body
Name [1] 3579 0
National Health and Medical Research Council
Country [1] 3579 0
Australia
Funding source category [2] 3642 0
Charities/Societies/Foundations
Name [2] 3642 0
Andrology Australia
Country [2] 3642 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council Queensland
Address
PO Box 201, Spring Hill Qld 4004
Country
Australia
Secondary sponsor category [1] 3215 0
University
Name [1] 3215 0
Griffith University
Address [1] 3215 0
School of Psychology (Mt Gravatt), Griffith University, Nathan QLD 4111
Country [1] 3215 0
Australia
Other collaborator category [1] 331 0
University
Name [1] 331 0
University of Texas
Address [1] 331 0
MD Anderson Cancer Center, University of Texas, Texas
Country [1] 331 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5621 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 5621 0
Office for Research, Bray Centre, Nathan Campus, Griffith University, Nathan Qld 4111
Ethics committee country [1] 5621 0
Australia
Date submitted for ethics approval [1] 5621 0
Approval date [1] 5621 0
02/07/2008
Ethics approval number [1] 5621 0
PSY/08/08/HREC

Summary
Brief summary
The most substantial long term morbidity from prostate cancer is sexual dysfunction with consequent adverse changes in couple and intimate relationships. Research to date has not identified an effective way to improve sexual and psychosocial adjustment for both men with prostate cancer and their partners. As well, the efficacy and cost effectiveness of peer counselling as opposed to professional models of service delivery has not yet been empirically tested. Proscan for Couples is a randomised control trial of a couples-based intervention that targets the specific challenges couples experience at diagnosis of localised prostate cancer and after radical prostatectomy. Intervention components include psycho-education; cognitive behavioural strategies; couple relationship education focussed on relationship enhancement and helping the couple to conjointly manage the stresses of cancer diagnosis and treatment; and specific psychosexual education and sexual communication. An audiovisual DVD resource supports the intervention that can be delivered with peer or nurse counselling. We will evaluate the efficacy of this intervention in a three arm randomised controlled trial comparing (1) usual care; (2) eight sessions of peer-delivered telephone support with the audiovisual resource; and (3) eight sessions of oncology nurse-delivered telephone counselling with the audiovisual resource. The trial will involve 210 couples with 70 couples in each condition (420 participants in total).
Trial website
Trial related presentations / publications
Chambers SK, Schover L, Halford K, Clutton S, Ferguson M, Gordon L, Gardiner RA, Occhipinti S, Dunn J. ProsCan for Couples: randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer who receive radical prostatectomy. BMC Cancer 2008; 8: 226.

Chambers SK, Schover L, Halford K, Ferguson M, Gardiner RA, Occhipinti S, Dunn J. ProsCan for Couples: a feasibility study for evaluating peer support within a controlled research design. Psycho-oncology 2013; 22: 475-479.

Chambers SK, Schover L, Nielsen L, Halford K, Clutton S, Gardiner RA, Dunn J, Occhipinti S. Couple distress after localised prostate cancer. Support Care Cancer 2013; 21: 2967-2976.

Chambers SK, Occhipinti S, Schover L, Nielsen L, Zajdlewicz L, Clutton S, Halford K, Gardiner RA, Dunn J. A randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer and their female partners. Psycho-oncology 2015; 24: 748-756.
Public notes

Contacts
Principal investigator
Name 28675 0
Prof Suzanne Chambers
Address 28675 0
Griffith Health Institute
Gold Coast Campus
Griffith University QLD 4222
Country 28675 0
Australia
Phone 28675 0
+61 7 5678 0008
Fax 28675 0
Email 28675 0
[email protected]
Contact person for public queries
Name 11832 0
Lisa Nielsen
Address 11832 0
Cancer Council Queensland
PO Box 201
Spring Hill Qld 4004
Country 11832 0
Australia
Phone 11832 0
+61 7 3634 5393
Fax 11832 0
+61 7 3259 8527
Email 11832 0
[email protected]
Contact person for scientific queries
Name 2760 0
Suzanne Chambers
Address 2760 0
Griffith Health Institute
Gold Coast Campus
Griffith University QLD 4222
Country 2760 0
Australia
Phone 2760 0
+61 7 5678 0008
Fax 2760 0
+61 7 3259 8527
Email 2760 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIProsCan for Couples: Randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer who receive radical prostatectomy2008https://doi.org/10.1186/1471-2407-8-226
N.B. These documents automatically identified may not have been verified by the study sponsor.