Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000181606
Ethics application status
Approved
Date submitted
18/08/2005
Date registered
19/08/2005
Date last updated
19/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Counselling to reduce anxiety and depressive symptoms in women with a new diagnosis of gynaecological cancer.
Scientific title
Counselling to reduce anxiety and depressive symptoms in women with a new diagnosis of gynaecological cancer.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women with gynaecological cancers. 277 0
Condition category
Condition code
Cancer 312 312 0 0
Cervical (Cervix)
Cancer 313 313 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of three Solution Focused Therapy counselling sessions conducted by a research nurse immediately post operatively. Follow up consists of 6 weeks and 4 month questionnaires (HADS, SWLS, Brief COPE and Yale Brown single item tool).
Intervention code [1] 208 0
None
Comparator / control treatment
The control group has normal practice for that particular hospital - usually this will consist of access to social workers and appropriate referral where necessary. Follow up is the same as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 367 0
The difference in HADS score
Timepoint [1] 367 0
At 6 weeks and 4 months follow up.
Secondary outcome [1] 821 0
SWLS
Timepoint [1] 821 0
Difference at 6 weeks and 4 months.
Secondary outcome [2] 822 0
Brief COPE
Timepoint [2] 822 0
Difference at 6 weeks and 4 months.
Secondary outcome [3] 823 0
Yale Brown single item tool.
Timepoint [3] 823 0
Difference at 6 weeks and 4 months.

Eligibility
Key inclusion criteria
Eligible patients will have a new diagnosis of a gynaecological cancer, not had a previous diagnosis of a cancer, not had a previous or current psychiatric history and will have scored higher than 5 on HADS at enrolment.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Randomisation occurs after enrolment with concealment by numbered sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated by random number generator with even #s allocated to intervention and odd #s to control.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2004
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)

Funding & Sponsors
Funding source category [1] 370 0
Charities/Societies/Foundations
Name [1] 370 0
Australian Rotary Health Research Fund
Country [1] 370 0
Australia
Primary sponsor type
Individual
Name
Dr Rodney Petersen
Address
Country
Secondary sponsor category [1] 293 0
None
Name [1] 293 0
None
Address [1] 293 0
Country [1] 293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1357 0
Royal Women's Hospital
Ethics committee address [1] 1357 0
Ethics committee country [1] 1357 0
Australia
Date submitted for ethics approval [1] 1357 0
Approval date [1] 1357 0
Ethics approval number [1] 1357 0
Ethics committee name [2] 1358 0
Freemasons Hospital
Ethics committee address [2] 1358 0
Ethics committee country [2] 1358 0
Australia
Date submitted for ethics approval [2] 1358 0
Approval date [2] 1358 0
Ethics approval number [2] 1358 0
Ethics committee name [3] 1359 0
Francis Perry House
Ethics committee address [3] 1359 0
Ethics committee country [3] 1359 0
Australia
Date submitted for ethics approval [3] 1359 0
Approval date [3] 1359 0
Ethics approval number [3] 1359 0
Ethics committee name [4] 1360 0
Sunshine Hospital
Ethics committee address [4] 1360 0
Ethics committee country [4] 1360 0
Australia
Date submitted for ethics approval [4] 1360 0
Approval date [4] 1360 0
Ethics approval number [4] 1360 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36112 0
Address 36112 0
Country 36112 0
Phone 36112 0
Fax 36112 0
Email 36112 0
Contact person for public queries
Name 9397 0
Dr Rodney Petersen
Address 9397 0
Department of Obstetrics and Gynaecology
c/- Royal Women's Hospital
Grattan St
Carlton VIC 3053
Country 9397 0
Australia
Phone 9397 0
+61 3 9344 2130
Fax 9397 0
+61 3 9347 1761
Email 9397 0
[email protected]
Contact person for scientific queries
Name 325 0
Dr Rodney Petersen
Address 325 0
Department of Obstetrics and Gynaecology
c/- Royal Women's Hospital
Grattan St
Carlton VIC 3053
Country 325 0
Australia
Phone 325 0
+61 3 9344 2130
Fax 325 0
+61 3 9347 1761
Email 325 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.