iving Well after Breast Cancer: supporting younger women to manage their weight with a partial meal replacement diet

Not Applicable

Recruiting

• Conditions: Breast cancer; Premenopausal breast cancer; Postmenopausal breast cancer; Obesity; Cancer - Breast; Diet and Nutrition - Obesity

• Registration Number: ACTRN12619000441112
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Women with premenopausal breast cancer
-Diagnosed with invasive breast cancer (stage I-IIIc)
-Oestrogen receptor positive disease (ER+)
-Premenopausal at diagnosis
-BMI greater than or equal to 27kg/m2
-Finished primary treatment (i.e. surgery, chemotherapy and/or radiotherapy)
-Received chemotherapy treatment for breast cancer

Women with postmenopausal breast cancer
•Diagnosed with invasive breast cancer (stage I-IIIc)
•Oestrogen receptor positive disease (ER+)
•Postmenopausal at diagnosis
•BMI greater than or equal to 27kg/m2
•Finished primary treatment (i.e. surgery, chemotherapy and/or radiotherapy)
•Aged between 58-63 years at diagnosis (under 65 years at study enrolment)
•Received chemotherapy treatment for breast cancer

Exclusion Criteria

Women with premenopausal breast cancer
-Ductal carcinoma in situ (DCIS; stage 0), distant metastases (stage IV) or triple negative breast cancer (TNBC)
-Diagnosed more than two years ago
-Currently pregnant or plan to conceive during the study period
-Contraindication to participating in an unsupervised program - active heart disease, impaired mobility, Insulin dependent diabetes, low liver/kidney function (from blood test)
-Currently taking or planning to start taking weight loss medications
-Insufficient English to complete assessments and participate in the intervention
-Unable to travel to Brisbane to complete study assessments
-Reporting depression/anxiety as a current significant problem that would interfere with study participation.
-Allergy or intolerance to soy, dairy or lactose

Women with postmenopausal breast cancer
•Ductal carcinoma in situ (DCIS; stage 0), distant metastases (stage IV) or triple negative breast cancer (TNBC)
•Diagnosed more than two years ago
•Currently pregnant or plan to conceive during the study period
•Contraindication to participating in an unsupervised program - active heart disease, impaired mobility, Insulin dependent diabetes, low liver/kidney function (from blood test)
•Currently taking or planning to start taking weight loss medications
•Insufficient English to complete assessments and participate in the intervention
•Unable to travel to Brisbane to complete study assessments
•Reporting depression/anxiety as a current significant problem that would interfere with study participation.
•Allergy or intolerance to soy, dairy or lactose

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility, measured by: <br>i) participant reach as measured by consent rates (#consenting / # interested and eligible / 100%)<br>ii) intervention adherence (#completed sessions / #scheduled sessions, x100%)<br>iii) participant retention (#completed follow-up testing /#completed baseline testing x100%); <br>iv) participant satisfaction (participant satisfaction survey designed for this study, semi-structured interview)<br><br>[i) participant reach (pre-intervention) <br>ii) intervention adherence<br>iii) participant retention: 12 weeks (baseline/end-of-intervention)<br>iv) participant satisfaction: 12 weeks (end-of-intervention)]

Secondary Outcome Measures

Name	Time	Method
Weight loss: % change from initial body weight measured using calibrated digital scales[Baseline, 12 weeks (end-of-intervention)];Body composition and bone mineral density; Dual-energy X-ray Absorptiometry (DEXA)[Baseline, 12 weeks (end-of-intervention) ];Dietary intake and adherence; Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) [Baseline, 6 weeks and 12 weeks (end-of-intervention) ];Physical activity and sedentary time: activPAL3 inclinometer; Actigraph GT3X+ accelerometer; Active Australia survey[Baseline, 12 weeks (end-of-intervention) ];Menopausal symptoms: Greene Climacteric Scale [Baseline ];Quality of life: FACT-B[Baseline, 12 weeks (end-of-intervention)];Depression and anxiety: Hospital Anxiety and Depression Scale (HADS)[Baseline, 12 weeks (end-of-intervention)];Body Image: Body Image and Relationships Scale (BIRS)[Baseline ]