Breast Cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Recruitment route 1: Prospective identification
Women who have completed their hospital-based treatment attend a discharge meeting and / or a holistic needs assessment (either in person or remotely).
Sponsors
University of Leeds
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Diagnosis of invasive breast cancer within 14 months prior to trial registration 1.1. Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical (cTNM) stage prior to therapy or pathologic (pTNM) stage at surgery; if patient is eligible based on either, they are eligible for the study as long as they do not have T4 disease prior to therapy 1.2. Bilateral breast carcinoma is allowed provided diagnoses are within 3 months of one another and at least one of the two breast carcinomas meet the eligibility criteria, and neither are Her-2 positive or inflammatory 2. HER-2 Negative as defined for the purpose of treatment. 3. Eligible tumour-node-metastasis (TNM) Stages include: 3.1. Oestrogen receptor (ER) and Progesterone receptor (PR) negative: T2 or T3 N0, T0-3N1-3 3.2. ER and/or PR positive: T0-3N1-3 or T3N0 ER and PR status is as defined for the purpose of treatment 4. Patients must have had a bilateral mammogram within 14 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Patients with bilateral total mastectomies do not require imaging). 5. All triple negative patients must receive chemotherapy of the treating clinician’s recommendation. 6. ER/PR positive patients must receive chemotherapy (of the treating physician’s choice) unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone. 7. All adjuvant or neoadjuvant chemotherapy and radiation completed at least 21 days prior to registration. Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable. 8. Surgical margins should be clear, with no tumour at ink for invasive, ductal in situ disease, and pleomorphic lobular carcinoma. Grossly positive margins should be re excised. Focally positive margins (<4mm) should ideally be re excised if technically possible but if not, consideration of radiotherapy boost should be given. Classical LCIS at the margin does not warrant re excision. 9. All surgery completed at least 3 months prior to registration. (Patients may have breast reconstruction during protocol participation, if scheduled for more than 6 months after registration into the trial). 10. Participants must be women 11. Capacity to provide informed consent 12. Aged =18 years at time of trial screening 13. Have a self-reported Body Mass Index of 27.0 – 45.0 kg/m² at time of trial screening 14. Have a BMI of 27.0 – 45.0 kg/m² at time of randomisation, using data from e-scales 15. Have sufficient proficiency in English to contribute to the intervention supporting consultations/ten top tips discussion, and complete the data collection required 16. Treated with curative intent 17. The participant is willing to complete the study assessments (questionnaires and anthropometric measures) 18. Participant reports they are able to stand without support to use the weighing scales provided, or has access to scales suitable for people who cannot stand without support SWAT INCLUSION CRITERIA All participants recruited into the We Sure Can trial, and who remain as fully participating (i.e., have not fully withdrawn or have died at each time-point where questionnaires are administered (4, 7 and 10-months post host trial randomisation) will be eligible for the SWAT
Exclusion criteria
Exclusion criteria: 1. Currently participating, or have consented to participate in another weight loss or dietary clinical trial. Co-enrolment in some trials involving pharmacologic therapy is allowed if there is no expected impact of the therapy on weight. 2. Unable to participate in a video or telephone call. 3. History of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal carcinoma in situ [DCIS] is permitted) 4. Patients cannot have metastatic breast cancer or inflammatory breast cancer 4.1. If there is a concern for metastatic disease, all investigations (e.g. chest x-ray, staging CT scan, bone scans), have been performed between first histologic diagnosis and registration 5. Patients with triple negative breast cancer are not eligible if they have T1N1mi disease 6. Patients with ER and / or PR positive breast cancer are not eligible if they have T0N0, T1N0, T2N0 or T1N1mi and T2N1mi disease 7. History of other malignancy within the past 4 years, except for malignancies with a >95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer). Patients cannot have metastatic cancer at any site. 8. Refusal of breast cancer treatment that has been recommended by the treating clinician. However, where it has been a shared decision not to follow treatment (i.e. due to borderline risk), women are eligible. 9. Current or historic diagnosis of an eating disorder 10. Taking antipsychotic medication 11. Patients who have required hospitalization for depression, have unstable/untreated major depression, active severe depression or bipolar disorder or personality disorder, and any other mental illness at a severity which would prevent participation in an organised weight loss programme and for giving informed consent. 12. Heart failure 13. Type I or Type II diabetes if prescribed any anti-diabetic medication other than metformin 14. Diabetes Insipidus 15. Taking Warfarin 16. Hypertension if prescribed more than one anti-hypertensive drug 17. Lactose intolerance 18. Vegan 19. Alcohol dependence 20. Dependence on substances other than tobacco 21. Taking any anti-obesity medication 22. Had bariatric surgery or scheduled bariatric surgery 23. Experienced a heart attack or stroke in the past 3 months 24. Taking monoamine oxidase inhibitor (MAOI) medication 25. History of malabsorption and/or serious digestive problems, including inflammatory bowel disease and chronic diarrhoea 26. Angina, atrial fibrillation, arrhythmia, or prolonged QT syndrome 27. Renal failure 28. Epilepsy 29. Active liver disease (except non-alcoholic fatty liver disease (NAFLD)), a history of hepatoma or within 6 months of onset of acute hepatitis 30. Active treatment or investigation for possible or confirmed gastric or duodenal ulcer; maintenance treatment with acid suppression is not a contraindication 31. Porphyria 32. Scheduled for any surgery (including breast reconstruction) within 6 months from registration 33. Oxygen-dependent pulmonary disease 34. Sleep apnoea requiring CPAP 35. Pregnant, breastfeeding, or within 4 months post-partum and not breastfeeding 36. Undergoing fertility treatment 37. Under investigation for any of the conditions that have been excluded 38. Comorbid conditions that would cause life expectancy of less than 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of patients screened for eligibility assessed at the screening stage 2. Number and proportion of patients eligible out of those screened and reasons for ineligibility assessed at the screening stage 3. Number and proportion of patients who consent out of those eligible and reasons for non-consent assessed at the recruitment stage 4. Number and proportion of patients consenting to randomisation out of those eligible and reasons for non-randomisation assessed at the recruitment stage 5. Number of participants randomised per site per month assessed at the end of the trial 6. Number and proportion of randomised participants lost-to-follow-up assessed at the end of trial 7. Number, proportion, type, and timing of participant withdrawals out of those randomised and reasons for withdrawal assessed at the end of trial 8. Questionnaire completion rates and method of completion at each time-point assessed at baseline, 4, 7, 10 and 13 months 9. Number of items of missing data per participant-reported outcome measure at each time-point (baseline, 4, 7, 10 and 13 months) 10. Number and proportion of participants with weight measurements at each time-point (baseline, 4, 7, 10 and 13 months) 11. Number and proportion of participants with physical activity monitor data at each time-point (baseline, 4, 7, 10 and 13 months) 12. Estimation of Intracluster Correlation Coefficient (ICC) assessed at the end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intervention adherence for patients in the intervention arm (number of intervention support consultations attended during the total diet replacement phase, amount of days covered by intervention product, measured by the intervention provider at the end of the total diet replacement phase) 2. Acceptability of the intervention products, explored in the qualitative process evaluation by interviews conducted at 4, 7 and 13 months 3. Acceptability of the intervention support consultations, explored in the qualitative process evaluation by interviews conducted at 4, 7 and 13 months. 4. Number and proportion of participants in the intervention arm deemed as having completed the intervention assessed at the end of trial from data during the total diet replacement phase 5. Number and proportion of participants in the enhanced usual care arm participating in a discussion of the healthy habits leaflet assessed at end of trial 6. Acceptability of the leaflet and discussion in the EUC arm, explored in the qualitative process evaluation by interviews conducted at 4, 7 and 13 months. 7. Treatment as usual content in both arms from participants (number of sessions attended and content of sessions) and sites (initiatives implemented during trial) assessed at the end of trial 8. Barriers, facilitators and reasons for non-attendance / non-compliance in both arms, explored in the qualitative process evaluation assessed by interviews conducted at 4, 7 and 13 months. 9. Site research team, and intervention providers' advisors’ acceptability of intervention and trial procedures, explored in the qualitative process evaluation by interviews conducted at 3months (with research nurses) and 15months post first patient randomised to the intervention arm (for the intervention provider interviews) 10. Number of participants who indicate they would consent to bloods collection in a future trial assessed at baseline by online questionnaire 11. Number of and details of SAEs (deaths, case of deat | — |
Countries
England, United Kingdom
Outcome results
None listed