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Trial registered on ANZCTR


Registration number
ACTRN12614000074695
Ethics application status
Approved
Date submitted
10/01/2014
Date registered
22/01/2014
Date last updated
22/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Get Healthy after Breast Cancer - examining the feasibility and acceptability of referring breast cancer survivors to the NSW ‘Get Healthy Service’ – a telephone-delivered program targeting physical activity, healthy diet and weight loss
Scientific title
Examining the feasibility and acceptability of referring breast cancer survivors to the NSW 'Get Healthy Service' - a telephone-delivered program targeting physical activity, healthy diet and weight loss
Secondary ID [1] 283888 0
Nil
Universal Trial Number (UTN)
Trial acronym
GHaBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 290873 0
Condition category
Condition code
Cancer 291232 291232 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research study seeks to look at the best ways of supporting women who have completed breast cancer treatment within the last 12 months to make lifestyle changes (increasing physical activity, improving eating habits, and achieving and maintaining a healthy weight) to promote longer-term health and well-being. Participants will receive 6 months of telephone counselling from the 'NSW Get Healthy Information and Coaching Service' (GHS). The GHS is a free telephone counselling program designed to help participants increase their physical activity, improve their diet and achieve and maintain a healthy weight. Participants receive up to 10 coaching calls, with an average duration of 13 minutes, over a period of 6 months (up to 6 calls during the first 12 weeks and up to 4 calls in the remaining 14 weeks). GHS health coaches are all university qualified health professionals, such as psychologists, nurses, dieticians, exercise physiologists, sports scientists, social workers, and physiotherapists. They receive further training to ensure they meet the requirements of the GHS. The aim of the study is to evaluate the feasibility and acceptability of the GHS for women within 12 months of end-of-treatment for stage I-III breast cancer.
Intervention code [1] 288563 0
Lifestyle
Intervention code [2] 288564 0
Behaviour
Comparator / control treatment
No control group - all participants receive the intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291226 0
The primary outcome of feasibility and acceptability will be measured via the following indicators: GHS uptake and number of calls (from GHS records), and women’s satisfaction with the GHS, including likes/dislikes and suggestions for improvement (as reported during qualitative telephone interviews conducted after the completion of the intervention).
Timepoint [1] 291226 0
End-of-intervention - 6 months after baseline assessment
Secondary outcome [1] 306283 0
Weight - objectively assessed during nurse visits
Timepoint [1] 306283 0
Baseline and post-intervention (6 months after baseline assessment)
Secondary outcome [2] 306284 0
Dietary intake as measured by the Fat & Fibre Behaviour Questionnaire (22 items including fruit and vegetable intake, fat and fibre intake, and breakfast consumption) during telephone interviews
Timepoint [2] 306284 0
Baseline and post-intervention (6 months after baseline assessment)
Secondary outcome [3] 306285 0
Physical activity as measured by the Active Australia Survey (8 items + 2 additional items on strength exercise) during telephone interviews
Timepoint [3] 306285 0
Baseline and post-intervention (6 months after baseline assessment)
Secondary outcome [4] 306286 0
Quality of life as measured by the PROMIS global health scale in the self-report questionnaire
Timepoint [4] 306286 0
Baseline and post-intervention (6 months after baseline assessment)
Secondary outcome [5] 306287 0
Fatigue as measured by the FACT-IT scale in the self-report questionnaire
Timepoint [5] 306287 0
Baseline and post-intervention (6 months after baseline assessment)
Secondary outcome [6] 306288 0
Depression as measured by the PROMIS SF-Depression 1.0 scale in the self-report questionnaire
Timepoint [6] 306288 0
Baseline and post-intervention (6 months after baseline assessment)
Secondary outcome [7] 306289 0
Body image as measured by the PAL Relationships and Body Image scale in the self-report questionnaire
Timepoint [7] 306289 0
Baseline and post-intervention (6 months after baseline assessment)
Secondary outcome [8] 306290 0
Menopausal symptoms as measured by the Greene Climacteric scale in the self-report questionnaire
Timepoint [8] 306290 0
Baseline and post-intervention (6 months after baseline assessment)

Eligibility
Key inclusion criteria
1. Female
2. First diagnosis of stage I-III breast cancer (unilateral or bilateral)
3. Aged 18-75 years
4. Completed primary treatment with curative intent (i.e., initial surgery, chemotherapy, radiation therapy) within the past 12 months (endocrine or targeted therapies may be ongoing)
5. Scheduled to return to the breast cancer clinic where they were recruited into the study for a follow-up appointment within approximately 6 months of starting the study
Minimum age
18 Years
Maximum age
75 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosed with ductal carcinoma in situ (DCIS; stage 0) or distant metastases (stage IV)
2. Pregnant
3. Contraindications to participating in an unsupervised program (active heart disease, impaired mobility)
4. Taking warfarin
5. Insufficient English to complete assessments and participate in a telephone-delivered program
6. Reporting depression/anxiety as a current significant problem that would interfere with study participation

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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A maximum of 50 women will be recruited into the study, which should allow an adequate test of the primary outcomes of feasibility and acceptability. The proposed sample size will also allow for estimation of effect sizes for quality of life, physical activity, dietary intake and changes in weight. Primary outcomes will be reported using descriptive statistics (i.e., means and standard deviations or their non-parametric equivalents, as appropriate to data distributions). Secondary outcomes will be assessed by examining pre-test to post-test changes using paired t-tests (or non-parametric tests, as appropriate). Statistical significance will be set at p < 0.05 (two-tailed). Follow-up qualitative interviews will be audio-recorded, transcribed, coded and then thematically analysed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1947 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 7688 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 288530 0
University
Name [1] 288530 0
The University of Queensland
Address [1] 288530 0
The University of Queensland, St Lucia, Brisbane, QLD, 4072
Country [1] 288530 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Population Health, Cancer Prevention Research Centre, Level 4 Public Health Building, Herston road, HERSTON, QLD, 4006
Country
Australia
Secondary sponsor category [1] 287241 0
Hospital
Name [1] 287241 0
Westmead Breast Cancer Institute
Address [1] 287241 0
Westmead Breast Cancer Institute, Level 1, Westmead Hospital, corner Hawkesbury & Darcy roads, WESTMEAD, NSW, 2145
Country [1] 287241 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290395 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 290395 0
Research Office, Room 1072, Level 1, Education Block, Westmead Hospital, Hawkesbury & Darcy roads, WESTMEAD, NSW, 2145
Ethics committee country [1] 290395 0
Australia
Date submitted for ethics approval [1] 290395 0
Approval date [1] 290395 0
22/11/2013
Ethics approval number [1] 290395 0
HREC2012/12/4.10(3628) AU RED HREC/12/WMEAD/428
Ethics committee name [2] 290396 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 290396 0
The University of Queensland, UQ Research & Innovation,
Cumbrae-Stewart Building, Research Road, BRISBANE, QLD, 4072, Australia
Ethics committee country [2] 290396 0
Australia
Date submitted for ethics approval [2] 290396 0
Approval date [2] 290396 0
11/12/2013
Ethics approval number [2] 290396 0
2013000426

Summary
Brief summary
This research study seeks to look at the best ways of supporting women who have completed breast cancer treatment within the last 12 months to make lifestyle changes (increasing physical activity, improving eating habits, and achieving and maintaining a healthy weight) to promote longer-term health and well-being.

Who is it for?
You may be eligible to join this study if you are a female aged between 18-75 years who has completed primary treatment with curative intent for stage I-III breast cancer (unilateral or bilateral) within the past 12 months.

Study details
All participants in this study will receive 6 months of telephone counselling from the NSW Get Healthy Service (GHS), which is a telephone counselling program for physical activity, healthy eating and weight loss. We are interested in whether this program is acceptable and beneficial for breast cancer survivors. In order to determine this, participants will be asked to complete a number of assessments and questionnaires on completion of the program to evaluate feasibility and acceptability of the project, changes in body weight, dietary intake, physical activity levels, quality of life, fatigue, depression, body image and menopausal symptoms.
Trial website
http://www.uq.edu.au/cprc/index.html?page=197476
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45462 0
Dr Sheleigh Lawler
Address 45462 0
The University of Queensland, School of Population Health, Cancer Prevention Research Centre, Level 4 Public Health Building, Herston road, HERSTON, QLD, 4006
Country 45462 0
Australia
Phone 45462 0
+61 7 3365 5544
Fax 45462 0
+61 7 3365 5540
Email 45462 0
s.lawler@sph.uq.edu.au
Contact person for public queries
Name 45463 0
Miss Erin Robson
Address 45463 0
The University of Queensland, School of Population Health, Cancer Prevention Research Centre, Level 4 Public Health Building, Herston road, HERSTON, QLD, 4006
Country 45463 0
Australia
Phone 45463 0
+61 7 3346 4669
Fax 45463 0
+61 7 3365 5540
Email 45463 0
e.robson@uq.edu.au
Contact person for scientific queries
Name 45464 0
Dr Sheleigh Lawler
Address 45464 0
The University of Queensland, School of Population Health, Cancer Prevention Research Centre, Level 4 Public Health Building, Herston road, HERSTON, QLD, 4006
Country 45464 0
Australia
Phone 45464 0
+61 7 3365 5544
Fax 45464 0
+61 7 3365 5540
Email 45464 0
s.lawler@sph.uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results