Malignant neoplasm of breast, obesity and other hyperalimentation Cancer
Conditions
Interventions
Participants will be identified by the breast care and oncology teams (including research nurses, breast care nurses, other healthcare professionals and consultants) in each of the associated NHS Trus
Sponsors
University of Hull
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged > = 18 within 36 months of the first histologic diagnosis of HER2-ve early breast cancer 2. Stage 2 or Stage 3 early breast cancer 3. BMI> 25 and/or waist circumference > 88cm. 4. Completed all (Neo)adjuvant chemotherapy, radiation and surgery at least 21 days prior to registration. 5. Concomitant hormonal therapy, bisphosphonates and CDK4/6 inhibitors are acceptable. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 with no co-morbidities that preclude a lifestyle intervention. 7. A patient at a participating NHS organisation
Exclusion criteria
Exclusion criteria: 1. Stage I and stage 4 breast cancer patients 2. HER2+ve diagnosis 3. Participating in another weight loss, physical activity or dietary intervention clinical trial 4. Currently on, planning on starting or within 6 weeks of the last dose of GLP-1 antagonists (Weight loss drug)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight measured using digital scales at baseline, 6, 12 (Primary endpoint) and 18 months post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric measures (height, BMI, hip and waist circumference) measured using standard techniques at baseline, 6, 12 and 18 months post randomisation;Body composition measured using local whole-body dual-energy X-ray absorptiometry (DXA) at baseline, 12 and 18 months (Optional);Blood pressure measured using a sphygmomanometer at baseline and 6, 12 and 18 months post randomisation;Health-related quality of life measured using the EORTC – QLQ-c30 and breast-specific module (BR45) at baseline, 6, 12 and 18 months post randomisation;Fatigue measured using the Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT-Fatigue) at baseline, 6,12 and 18 months post-randomisation;Fear of cancer recurrence measured using the 7-point Fear of Cancer Recurrence Scale at baseline, 6,12 and 18 months post-randomisation;Body image measured using the Body Image Scale at baseline, 6,12 and 18 months post-randomisation;Self-report physical activity measured using the modified Godin Leisure Time Physical Activity Questionnaire at baseline, 6, 12 and 18 months post-randomisation;Participant eating behaviours, including fruit and vegetable intake, measured using a bespoke questionnaire based on the Scottish Health Survey at baseline, 6,12 and 18 months post-randomisation;Alcohol consumption measured using the AUDIT-C questionnaire at baseline, 6,12 and 18 months post-randomisation;Objective physical activity and sedentary behaviour measured using accelerometers at baseline, 6,12 and 18 months post-randomisation;COM-B constructs (Capability, Opportunity and Motivation) within the intervention group measured using a brief 6-item questionnaire at baseline, 6,12 and 18 months post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactEllie;Matthew Langworthy;Northgraves
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Outcome results
None listed