Prehabilitation and RecOVERy From Surgery for Breast Cancer Study

NCT ID: NCT05901142

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2024-12-31

Brief Summary

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

Exercise; Breast Neoplasm Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise-based multi-phasic, multi-modal intervention

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

Group Type: EXPERIMENTAL

Exercise-based multi-phasic, multi-modal intervention

Intervention Type: BEHAVIORAL

Pre-op: 2*60min supervised; 1*30min unsupervised walking sessions per week Supervised session: Aerobic: 8*60secs star jump, squat thrust, high knees with 90sec rest. Elastic resistance: 2*10-12reps of chest press, seated row, leg press, 'lat' pulldown, and either abdominal flexion or lumbar extension-alternated, with 60-90sec rest. Targeted physiotherapy: general breathing exercises, active-assisted range of motion (RoM) exercises, and active-resisted RoM exercises

Postop: 1*60min supervised exercise; unsupervised walking [2*30min weeks 1-2; 3*30min week 3; 4*30min weeks 4-6] session per week Supervised session: Aerobic: As above using full body extension, squat jump, static sprint in week 1-4. Progressed to those performed preoperatively from week 5. Elastic resistance: As above from week 4, performed 3*week. Targeted physiotherapy: As above, with active-assisted RoM progressing from 1*10reps in week 1, to 2*10reps in weeks 2-4, and 3*10reps in weeks 4-6

Interventions

Exercise-based multi-phasic, multi-modal intervention

Pre-op: 2*60min supervised; 1*30min unsupervised walking sessions per week Supervised session: Aerobic: 8*60secs star jump, squat thrust, high knees with 90sec rest. Elastic resistance: 2*10-12reps of chest press, seated row, leg press, 'lat' pulldown, and either abdominal flexion or lumbar extension-alternated, with 60-90sec rest. Targeted physiotherapy: general breathing exercises, active-assisted range of motion (RoM) exercises, and active-resisted RoM exercises

Postop: 1*60min supervised exercise; unsupervised walking [2*30min weeks 1-2; 3*30min week 3; 4*30min weeks 4-6] session per week Supervised session: Aerobic: As above using full body extension, squat jump, static sprint in week 1-4. Progressed to those performed preoperatively from week 5. Elastic resistance: As above from week 4, performed 3*week. Targeted physiotherapy: As above, with active-assisted RoM progressing from 1*10reps in week 1, to 2*10reps in weeks 2-4, and 3*10reps in weeks 4-6

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wolverhampton

OTHER

Sponsor Role: collaborator

University of Hull

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Bath

OTHER

Sponsor Role: collaborator

Aston University

OTHER

Sponsor Role: collaborator

Staffordshire University

OTHER

Sponsor Role: collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amtul Carmichael

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Derby and Burton NHS Foundation Trust

Locations

University Hospital Derby and Burton

Burton-on-Trent, , United Kingdom

Countries

United Kingdom

Other Identifiers

PROVERB

Identifier Type: -

Identifier Source: org_study_id