Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Participants will be recruited via breast care teams (including research nurses, breast care nurses, other healthcare professionals and consultants) in each of the associated NHS Trusts through face t
Sponsors
Northumbria University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pre-/post-menopausal breast cancer patients who completed surgery, radiotherapy and/or chemotherapy for early stage disease (I-III) =36 months previously and =8weeks after final chemotherapy cycle 2. Women with ER+ and HER2- tumour diagnoses; overweight/obese (BMI =25 or >30kg/m2) and/or waist circumference >88 cm 3. Willing and able to attend group lifestyle counselling/Support & Skills Workshops
Exclusion criteria
Exclusion criteria: 1. Metastatic/inoperable or active loco-regional disease; BMI = 3 months 3. Severe physical/psychiatric or comorbid impairment (e.g. arthritis/multiple sclerosis) 4. Uncontrolled T2DM and CVD or severe osteoporosis 5. No telephone contact 6. Unable to consent 7. Enrolled on another weight loss/lifestyle behaviour change trial 8. Already engaged in > 150 min.week-1 of moderate-intensity PA 9. Expecting to have surgery during the study that would affect adherence to the study 10. Unable to speak/read English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body weight (kg) measured using standard techniques at baseline, 6 and 12 months post-randomisation 2. Health-related quality of life measured using the EORTC – QLQ-c30 and breast specific module (BR23) at baseline, 6 and 12 months post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anthropometric measures (height, BMI, hip and waist circumference) measured using standard techniques at baseline, 6 and 12 months post-randomisation 2. Blood pressure measured via sphygmomanometer at baseline, 6 and 12 months post-randomisation 3. Body composition (skeletal muscle and fat mass) measured via DXA at baseline, 6 and 12 months post-randomisation 4. Fatigue measured via the Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT-Fatigue) at baseline, 6 and 12 months post-randomisation 5. Fear of cancer recurrence measured using the 7-point Fear of Cancer Recurrence Scale at baseline, 6 and 12 months post-randomisation 6. Body image measured with the Body Image Scale at baseline, 6 and 12 months post-randomisation 7. Self-report physical activity measured via the modified Godin Leisure Time Physical Activity Questionnaire at baseline, 6 and 12 months post-randomisation 8. Participant eating behaviours, including fruit and vegetable intake, assessed using a bespoke questionnaire based on the Scottish Health Survey at baseline, 6 and 12 months post randomisation 9. Alcohol consumption measured via the AUDIT-C questionnaire at baseline, 6 and 12 months post-randomisation 10. Participant fitness measured via a submaximal incremental treadmill test using the BRUCE protocol at baseline, 6 and 12 months post-randomisation 11. Objective physical activity and sedentary behaviour measured by ActivPAL accelerometers at baseline, 6 and 12 months post-randomisation 12. Inflammatory markers, adipokines, indices of insulin/IGF metabolism and biomarkers for breast cancer recurrence measured via blood samples at baseline, 6 and 12 months post-randomisation 13. Health economics measured using healthcare resource use measured at 3, 6, 9 and 12 months post-randomisation and health-related quality of life using the EuroQol EQ-5D-5L at baseline, 6 and 12 months post randomisation | — |
Countries
England, United Kingdom
Outcome results
None listed