Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000186550
Ethics application status
Approved
Date submitted
9/05/2006
Date registered
17/05/2006
Date last updated
17/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of psycho-educational intervention on hot flushes and related symptoms after treatment for localised breast cancer
Scientific title
Effect of psycho-educational intervention on hot flushes and related symptoms (insomnia, fatigue, anxiety and mood problems) after treatment for localised breast cancer - Pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hot flushes in women with previous localised breast cancer 1159 0
Condition category
Condition code
Cancer 1244 1244 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot pre-test/post-test design; psycho-educational intervention utilising evidence-based information provision, cognitive-behavioural strategies and relaxation training with four weekly group sessions (duration of the intervention: 4 weeks). Each group session will last 90 minutes.
Intervention code [1] 1031 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1678 0
Frequency of hot flushes measured with a "hot flushes diary" where each hot flush and its severity will be recorded for 7 days at each timepoint.
Timepoint [1] 1678 0
Measured twice before the intervention (at 4 weeks apart) and twice after the intervention (at the end of the intervention and 3 months after).
Primary outcome [2] 1679 0
Daily hot flush score (frequency x severity score for each HF) measured with a "hot flushes diary" where each hot flush and its severity will be recorded for 7 days at each timepoint.
Timepoint [2] 1679 0
Measured twice before the intervention (at 4 weeks apart) and twice after the intervention (at the end of the intervention and 3 months after).
Secondary outcome [1] 3017 0
Changes in interference of hot flushes with different aspects of life
Timepoint [1] 3017 0
Measured twice before the intervention (at 4 weeks apart) and twice after the intervention (at the end of the intervention and 3 months after).
Secondary outcome [2] 3018 0
Changes in sleep, fatigue, anxiety and mood disturbance
Timepoint [2] 3018 0
Measured twice before the intervention (at 4 weeks apart) and twice after the intervention (at the end of the intervention and 3 months after).

Eligibility
Key inclusion criteria
Localised breast cancer (Stage I, II & III); Adjuvant therapy (surgery ± chemotherapy ± radiotherapy) completed for more than 3 months but no more than 5 years (may take tamoxifen or aromatase inhibitor but no modification allowed during the time of the study); Have HF (³ 5 / 24 hours).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women taking pharmacological medications for HF; Women with severe depression who are currently seeing a psychiatrist or taking antidepressants for < 3 months; Women currently undergoing cognitive-behavioural therapy; Women cognitively impaired.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot pre-test/post-test design with two baseline assessments
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1359 0
Charities/Societies/Foundations
Name [1] 1359 0
Supportive Care Research Group at the Peter MacCallum Cancer Centre
Country [1] 1359 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Supportive Care Research Group at the Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 1200 0
None
Name [1] 1200 0
none
Address [1] 1200 0
Country [1] 1200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2716 0
Clinical Research Committee of the Peter MacCallum Cancer Centre
Ethics committee address [1] 2716 0
Ethics committee country [1] 2716 0
Australia
Date submitted for ethics approval [1] 2716 0
Approval date [1] 2716 0
Ethics approval number [1] 2716 0
06/25

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

Contacts
Principal investigator
Name 35349 0
Address 35349 0
Country 35349 0
Phone 35349 0
Fax 35349 0
Email 35349 0
Contact person for public queries
Name 10220 0
Anouk Tremblay
Address 10220 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 10220 0
Australia
Phone 10220 0
+61 3 96561847
Fax 10220 0
Email 10220 0
[email protected]
Contact person for scientific queries
Name 1148 0
Lisa Sheeran
Address 1148 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 1148 0
Australia
Phone 1148 0
+61 3 96563561
Fax 1148 0
+61 3 96561337
Email 1148 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.