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Trial registered on ANZCTR


Registration number
ACTRN12612000997853
Ethics application status
Approved
Date submitted
14/09/2012
Date registered
18/09/2012
Date last updated
27/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of a telephone-delivered weight loss intervention for overweight and obese women following treatment for breast cancer (Living Well after Breast Cancer)
Scientific title
A randomised controlled trial of a 12-month telephone-delivered weight loss intervention compared to usual care for overweight and obese women following treatment for breast cancer
Secondary ID [1] 281232 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 287422 0
Overweight/obesity 287443 0
Condition category
Condition code
Cancer 287755 287755 0 0
Breast
Diet and Nutrition 287756 287756 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: Participants will be posted feedback on their baseline assessment along with program materials (detailed workbook, set of digital scales, measuring tape, pedometer, kilojoule/calorie counter book and self-monitoring diary), which will be referred to over the 12-month intervention. Intervention participants will also be posted the same newsletters that the usual care participants receive (see below). They will receive up to 22 telephone calls from a Lifestyle Coach (Accredited Practising Dietitian with additional study-specific training in exercise promotion) over 12-months. The intervention is divided into 2 phases; an initial intensive 6-month phase (6 x weekly calls followed by 10 x fortnightly calls) followed by a 6-month maintenance-enhancement phase (6 x monthly calls). Each call will usually take around 30 minutes and will focus on increasing physical activity, improving eating habits (reducing energy intake) and reducing sitting time as well as developing behaviour change skills. Participants may choose to receive supplementary text messages (SMS) to give additional support for behaviour change. Participants will be encouraged to aim for weight loss of between 5-10% of their baseline body weight.
Intervention code [1] 285699 0
Lifestyle
Intervention code [2] 285713 0
Treatment: Other
Intervention code [3] 285714 0
Behaviour
Comparator / control treatment
Participants in the usual care group will continue to receive their standard medical care. In addition, these participants will be posted written materials after each of their study assessments (baseline, 6-months, 12-months, 18-months). These written materials will include brief feedback from their study assessment, a Breast Cancer Network of Australia newsletter and a study newsletter.
Control group
Active

Outcomes
Primary outcome [1] 287990 0
weight loss (% initial body weight) (calibrated digital scales)
Timepoint [1] 287990 0
6-months (short-term), 12-months (end-of-intervention) and 18-months (maintenance post-intervention)
Secondary outcome [1] 299194 0
physical activity (accelerometry; Active Australia Survey)
Timepoint [1] 299194 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [2] 299195 0
dietary intake (2 x 24 hour dietary recall; Fat and Fibre Behaviour Questionnaire)
Timepoint [2] 299195 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [3] 299196 0
waist circumference
Timepoint [3] 299196 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [4] 299197 0
hip circumference
Timepoint [4] 299197 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [5] 299198 0
body composition (body fat and lean body mass) (Lunar Prodigy DXA scanner)
Timepoint [5] 299198 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [6] 299199 0
bone mineral density (Lunar Prodigy DXA scanner)
Timepoint [6] 299199 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [7] 299200 0
blood pressure (Omron T8)
Timepoint [7] 299200 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [8] 299201 0
clinical biomarkers of metabolic health (glucose, lipids, HbA1c, insulin, leptin, adiponectin, C Reactive Protein) (blood analysis)
Timepoint [8] 299201 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [9] 299202 0
genomic and DNA methylation-based biomarkers (blood analysis)
Timepoint [9] 299202 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [10] 299203 0
quality of life (PROMIS Global Health Scale)
Timepoint [10] 299203 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [11] 299204 0
fatigue (FACT-IT)
Timepoint [11] 299204 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [12] 299205 0
body image (Body Image & Relationships Scale)
Timepoint [12] 299205 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [13] 299206 0
menopausal symptoms (Greene Climacteric Scale)
Timepoint [13] 299206 0
baseline, 6-months, 12-months and 18-months
Secondary outcome [14] 299207 0
cost-effectiveness (cost per DALY of intervention compared to usual care)
Timepoint [14] 299207 0
completion of the study

Eligibility
Key inclusion criteria
Diagnosed with stage I-III breast cancer

Finished primary treatment for breast cancer (i.e., surgery, chemotherapy and/or radiotherapy)

Body Mass Index between 25 and 45 kg/m2
Minimum age
18 Years
Maximum age
75 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed with ductal carcinoma in situ (DCIS; stage 0) or distant metastases (stage IV)

Contraindications to participating in an unsupervised program – receiving dialysis, mobility issues, planning hip/knee replacement in next six months, taking Warfarin, pregnant, active heart disease, breathing problems, use of weight loss medications, weight loss surgery

Unable to travel to Brisbane to complete study assessments

Not sufficiently fluent in English to complete assessments and
participate in telephone-delivered program

Reporting depression/anxiety/other mental health condition as a current significant problem that would interfere with study participation

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study will use a two-stage consent process. Potentially eligible women will be identified through six hospitals within the greater Brisbane area – Mater Adult Hospital, Mater Private Hospital, Royal Brisbane and Women’s Hospital, Redcliffe Hospital, Greenslopes Private Hospital, North West Private Hospital. Nursing staff (e.g., Breast Care Nurse, Cancer Care Coordinator) will give a brief overview of the study and a study information pack (containing a study information brochure, consent to contact form and reply paid envelope) to patients. Women who are interested in finding out more about the study are encouraged to complete the consent to contact form and post it back to the research team. Women who consent to being contacted by the research team will be mailed a participant information sheet and consent form and then will receive a telephone call to screen for eligibility, answer any questions and gain informed consent to participate in the study. The signed consent form will be returned to the researchers. Consenting participants will complete a baseline assessment. Following completion of the baseline assessment, a staff member who does not work on the study will allocate participants to the intervention or usual care group using a computer generated randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A staff member who does not work on the study will create a computer-generated randomisation plan using uneven block sizes (www.randomization.com). This randomisation plan will be used to allocate all participants to either the usual care group or the intervention group.
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
Completed
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)
QLD
Recruitment hospital [1] 448 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 449 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 450 0
Mater Private Hospital - South Brisbane
Recruitment hospital [4] 451 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [5] 452 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [6] 453 0
North West Brisbane Private Hospital - Everton Park
Recruitment hospital [7] 5295 0
Holy Spirit Northside - Chermside
Recruitment postcode(s) [1] 5740 0
4101
Recruitment postcode(s) [2] 5776 0
4029
Recruitment postcode(s) [3] 5777 0
4120
Recruitment postcode(s) [4] 5778 0
4020
Recruitment postcode(s) [5] 5779 0
4053
Recruitment postcode(s) [6] 12762 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 286008 0
Government body
Name [1] 286008 0
National Health and Medical Research Council (NHMRC)
Address [1] 286008 0
National Health and Medical Research Council
Level 1, 16 Marcus Clarke St
Canberra ACT 2601
Country [1] 286008 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Brisbane
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 284828 0
None
Name [1] 284828 0
Address [1] 284828 0
Country [1] 284828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288055 0
Greenslopes Private Hospital Human Research Ethics Committee
Ethics committee address [1] 288055 0
Greenslopes Private Hospital
Newdegate St
Greenslopes Qld 4120
Ethics committee country [1] 288055 0
Australia
Date submitted for ethics approval [1] 288055 0
Approval date [1] 288055 0
19/06/2012
Ethics approval number [1] 288055 0
Protocol 12/26
Ethics committee name [2] 288056 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [2] 288056 0
Office of the Human Research Ethics Committee
Royal Brisbane and Women's Hospital
Metro North Hospital and Health Service
Butterfield St
Herston Qld 4029
Ethics committee country [2] 288056 0
Australia
Date submitted for ethics approval [2] 288056 0
Approval date [2] 288056 0
17/08/2012
Ethics approval number [2] 288056 0
HREC/12/QRBW/149
Ethics committee name [3] 288057 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [3] 288057 0
Research & Innovation Division
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia Qld 4072
Ethics committee country [3] 288057 0
Australia
Date submitted for ethics approval [3] 288057 0
Approval date [3] 288057 0
22/08/2012
Ethics approval number [3] 288057 0
2012000944

Summary
Brief summary
The purpose of this study is to evaluate a 12-month telephone-delivered weight loss program, as compared to usual care, for women who have recently completed primary treatment for breast cancer.

Who is it for? You may be eligible to join this study if you are a woman aged between 18 and 75 years who has been diagnosed with stage I-III breast cancer for which you have finished primary treatment (i.e. surgery, chemotherapy and/or radiotherapy). You should also have a Body Mass Index between 25 and 45 kg/m2, indicating overweight/obesity and be able to travel to Brisbane to complete study assessments.

Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive a telephone-delivered weight loss intervention which involves up to 22 telephone calls from a Lifestyle Coach over a 12 month period. They will also receive program materials, including a detailed workbook, set of digital scales, measuring tape, pedometer, kilojoule/calorie counter book and self-monitoring diary. Participants in the other group will continue to receive their standard medical care plus 6 monthly feedback and newsletters.

The program will be evaluated on its ability to achieve weight loss, and improve body composition, physical activity, dietary intake, clinical biomarkers of metabolic health, genomic and DNA methylation-based biomarkers, blood pressure and patient-reported outcomes (quality of life, body image, fatigue, menopausal symptoms).
Trial website
Trial related presentations / publications
Reeves MM, Terranova CO, Erickson J, Job JR, Brookes DSK, McCarthy N, Hickman IJ, Lawler SP, Fjeldsoe BS, Healy GN, Winkler EAH, Janda M, Veerman JL, Ware R, Prins J, Vos T, Demark-Wahnefried, Eakin EG. Living Well after Breast Cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer. BMC Cancer, 2016;16:830.
Public notes

Contacts
Principal investigator
Name 34713 0
A/Prof Marina Reeves
Address 34713 0
Cancer Prevention Research Centre, School of Public Health, Public Health Building, University of Queensland, Herston Road, Herston Qld 4006
Country 34713 0
Australia
Phone 34713 0
+61 7 33464692
Fax 34713 0
+61 7 33655540
Email 34713 0
m.reeves@sph.uq.edu.au
Contact person for public queries
Name 17960 0
A/Prof Marina Reeves
Address 17960 0
Cancer Prevention Research Centre, School of Public Health, Public Health Building, University of Queensland, Herston Road, Herston Qld 4006
Country 17960 0
Australia
Phone 17960 0
+61 7 33464692
Fax 17960 0
+61 7 33655540
Email 17960 0
m.reeves@sph.uq.edu.au
Contact person for scientific queries
Name 8888 0
A/Prof Marina Reeves
Address 8888 0
Cancer Prevention Research Centre, School of Public Health, Public Health Building, University of Queensland, Herston Road, Herston Qld 4006
Country 8888 0
Australia
Phone 8888 0
+61 7 33464692
Fax 8888 0
+61 7 33655540
Email 8888 0
m.reeves@sph.uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary