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
Hot flushes are frequent and bothersome to many women previously diagnosed with breast cancer. Fatigue, insomnia, anxiety and mood problems are often related to hot flushes. According to the literature a psycho-educational intervention seems to be a promising treatment for hot flushes but has not been rigorously studied in women with previous breast cancer.
The primary purpose of the study will be changes in frequency of hot flushes and daily hot flush score (frequency x severity score for each HF).
Hypothesis: A psycho-educational intervention utilising information provision, cognitive behavioural strategies and relaxation training will improve hot flushes, fatigue, insomnia, anxiety and mood disturbance in women with previous breast cancer.
The psycho-educational intervention will involve four weekly group sessions during which information about hot flushes and related symptoms (insomnia, fatigue, anxiety and mood problems) will be given. We will also give strategies to improve and manage these symptoms according to some cognitive-behavioural strategies. In addition relaxation techniques will be taught to try to reduce the frequency/severity of hot flushes.
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.