Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000534280
Ethics application status
Approved
Date submitted
11/06/2009
Date registered
3/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive Existential Therapy for men with early stage prostate cancer and their partners
Scientific title
A randomized controlled trial to assess the efficacy of Cognitive Existential Therapy on the level of psychological distress in men with early stage prostate cancer and their partners
Secondary ID [1] 850 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 4689 0
coping 4690 0
depression 4691 0
anxiety 4692 0
Condition category
Condition code
Mental Health 5004 5004 0 0
Depression
Cancer 237453 237453 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Existential Couples Therapy consists of 6 weekly 90 minute sessions. Couples are seen together by with a psychologist. The aim of the therapy is tohelp couples adust to the prostate cancer diagnosis and strengthen their relationship. Topics covered include: coping with physical changes/symptoms and changing care needs; effective communication; promoting support between partners; existential considerations; coping strategies; and planning for the future.
Intervention code [1] 4452 0
Prevention
Intervention code [2] 4453 0
Treatment: Other
Comparator / control treatment
Standard treatment involves provision of a medical booklet about prostate cancer (routinely given to all prostate cancer patients) and medical treatment as usual. No therapy is provided for control participants.
Control group
Active

Outcomes
Primary outcome [1] 5845 0
level of psychological distress (scores on Mental Health Inventory and Impact of Events Scale-Revised)
Timepoint [1] 5845 0
at baseline, immediately post intervention and at 6 and 26 weeks post intervention
Secondary outcome [1] 241862 0
quality or relating (scores on Family (Couples) Relationship Index and Cancer Support Inventory)
Timepoint [1] 241862 0
at baseline, immediately post intervention and at 6 and 26 weeks post intervention
Secondary outcome [2] 241863 0
level of coping (scores on Brief COPE and Benefit Finding Scale)
Timepoint [2] 241863 0
at baseline, immediately post intervention and at 6 and 26 weeks post intervention

Eligibility
Key inclusion criteria
1. couples must have been married or living together for at least 12 months
2. one partner must have histologically confirmed early stage prostate cancer
3. the diagnosis of prostate cancer must have been made no more than 12 months prior to the date of recruitment
4. both partners must be able to commit to 6 sessions of Cognitive Existential Couples Therapy
5. both partners must be able to read and write English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. presence of domestic violence
2. long-standing, intractible relationship difficulties
3. severe substance abuse in either partner
4. severe psychotic illness, dementia or intellectual disability in either partner
5. active suicidal ideation in either partner
6. another type of active cancer in either partner
7. another severely dibilitating or life-threatening illness requiring active treatment in either partner

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. Randomization will be conducted by the statistics department at the Peter MacCallum Cancer Centre who will not be involved in the recruitment of participants. Once a couple has been recruited to the study the statistics department will be contacted to find out to which group the couple will be assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted blocks randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4870 0
Other
Name [1] 4870 0
beyondblue Limited
Country [1] 4870 0
Australia
Primary sponsor type
Individual
Name
Dr Jeremy Couper
Address
Peter MacCallum Cancer Centre
St Andrew's Place
East Melbourne Victoria 3002
Country
Australia
Secondary sponsor category [1] 4632 0
Individual
Name [1] 4632 0
Professor Anthony Love
Address [1] 4632 0
School of Behavioural and Social Science and Humanities
University of Ballarat, Mount Helen Campus
University Drive
Mount Helen
Ballarat, Victoria 3353
Country [1] 4632 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6933 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 6933 0
Peter MacCallum Cancer Centre
St Andrew's Place
East Melbourne Victoria 3002
Ethics committee country [1] 6933 0
Australia
Date submitted for ethics approval [1] 6933 0
Approval date [1] 6933 0
19/05/2009
Ethics approval number [1] 6933 0
09/17

Summary
Brief summary
This study is a randomized controlled trial designed to assess the efficacy of Cognitive Existential Couples Therapy for men with early stage prostate cancer and their partners. Research has shown that men with early stage prostate cancer may experience considerable psychological distress in the months following their initial diagnosis. Research has also shown that their partners may also experience distress at the time of the diagnosis which, if left untreated, can lead to subsequent relationship difficulties. Cognitive Existential Couples Therapy has been designed to help couples cope in the aftermath of a prostate cancer diagnosis. It is predicted that couples who receive Cognitive Existential Couples Therapy will experience less psychological distress and show improved quality of relating and more adaptive coping compared to couples who receive medical treatment as usual.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29545 0
Address 29545 0
Country 29545 0
Phone 29545 0
Fax 29545 0
Email 29545 0
Contact person for public queries
Name 12792 0
Dr Jeremy Couper
Address 12792 0
Peter MacCallum Cancer Centre
St Andrew's Place
East Melbourne Victoria 3002
Country 12792 0
Australia
Phone 12792 0
61 3 9656 3574
Fax 12792 0
61 3 9656 1095
Email 12792 0
[email protected]
Contact person for scientific queries
Name 3720 0
Dr Jeremy Couper
Address 3720 0
Peter MacCallum Cancer Centre
St Andrew's Place
East Melbourne Victoria 3002
Country 3720 0
Australia
Phone 3720 0
61 3 9656 3574
Fax 3720 0
61 3 9656 1095
Email 3720 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
No additional documents have been identified.