None listed
Conditions
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).
Interventions
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
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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
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
Outcome results
None listed