Clinical trial · Interventional
Prehabilitation and RecOVERy From Surgery for Breast Cancer Study
The Feasibility of a Multi-phasic Exercise-based Intervention Utilising the Health Action Process Approach, Dyadic Coping and Wearable Technology in Women Before and After Surgery for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background and study aims: Nine out of ten women experience some negative effects due to their disease or its treatment such as anxiety, depression, weight gain and low quality of life. Research shows that exercise may help women overcome some of these effects. The investigators also know that most women become physically inactive after cancer treatment. Therefore, The investigators feel it is important that women get into a routine of doing regular exercise before they start their cancer treatment, this is called prehabilitation. The investigators believe that prehabilitation might help to build confidence and help women to continue exercising after their cancer treatment. The investigators are doing this study to find out if a remote (NHS Attend Anywhere), multimodal (aerobic, resistance and targeted exercise), behavioural change (Health Action Process Approach (HAPA), dyadic coping (the collective effort to dealing with the stress of breast cancer diagnosis and treatment), and wearable technology), multiphasic (pre- and post-surgery) intervention is feasible in the short time frame between diagnosis of breast cancer and surgery (less than 31 days). The investigators would also like to find out whether it is feasible for women to begin an exercise rehabilitation programme two weeks after their operation. If successful, the results will potentially enable us in the future to tailor the support gievn to women to help them prepare and recover from breast cancer treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
| Exercise | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise-based multi-phasic, multi-modal intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exercise-based multi-phasic, multi-modal intervention
- description
- An exercise-based multi-phasic (pre-surgery and post-surgery) and multi-modal (exercise, targeted physiotherapy, dietary advice, and psychological coping and behaviour change) intervention
- interventionNames
- Behavioral: Exercise-based multi-phasic, multi-modal intervention
Primary outcomes (5)
- measure
- Number of participants recruited during the 36 week recruitment period
- timeFrame
- Assessed immediately after the 36 week recruitment period
- description
- The investigators aim to recruit 34 participants in 36 weeks, equating to a recruitment rate of approximately one patient each week.
- measure
- Number of participants retained during the interventional period
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females aged 18 years or older * Scheduled to undergo elective surgery for biopsy-proven breast cancer (lumpectomy or mastectomy) for resection and/or reconstruction purposes * Patients scheduled after diagnosis of invasive breast cancer and ductal carcinoma in situ (DCIS) * Able to communicate in English and able to provide and understand informed consent * Willing to participate in supervised and home-based exercise * Have the approval of operating surgeon * At least 2 weeks until surgery * Access to a computer or smart device connected to the world wide web Exclusion Criteria: * Evidence in the medical record of an absolute contraindication for exercise \[e.g., Heart insufficiency \> New York Heart Association (NYHA) III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) \< 30%, Creatinine\> 3 mg/dl); insufficient haematological capacity like either haemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability\]. * Metastatic breast cancer * Current smokers * Not fluent in written and spoken English * Engaging in regular exercise (at least 150 min per week of moderate exercise or at least 75 min per week of vigorous exercise, or an equivalent combination of moderate and vigorous exercise). This criterion will be assessed via the Physical Activity Vital Signs (PAVS) questionnaire, which asks the following two questions: 1) "Please describe your level of physical activity, \[first by\] minutes per day, \[followed by\] number of days each week", and 2) "At what intensity (how hard): light (like a casual walk), moderate (like a brisk walk), or vigorous (like a jog/run)?" (Ball et al., 2016). The questionnaire is scored by multiplying the days by minutes of physical activity to create an estimate of minutes per week of at least moderate-to-vigorous physical activity. * Symptoms of long-covid/post covid syndrome
References
Publications (0)
Data not yet available