Prehabilitation and RecOVERy From Surgery for Breast Cancer Study

NCT05901142 | Active Not Recruiting

• 1 other identifier: PROVERB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Number of participants recruited during the 36 week recruitment period

  The investigators aim to recruit 34 participants in 36 weeks, equating to a recruitment rate of approximately one patient each week.

  Assessed immediately after the 36 week recruitment period

• Number of participants retained during the interventional period

  The investigators aim to retain 75% (n = 25) of our sample throughout the interventional period, which includes a perioperative (\~4 weeks) and post operative multimodal intervention (\~6 weeks)

  Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)

• Number of participants who completed at least 70% of supervised sessions and not lower than 60% for of unsupervised sessions, spanning both the pre- and postoperative periods.

  Adherence to remotely supervised exercise sessions (spanning both pre- and postoperative phases) is at least 70%, and not lower than 60% for adherence to unsupervised exercise sessions.

  Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)

• Number of participants who had an average daily wear time is ≥10 hours per day and ≥4 days per week

  Feasibility of using wearable technology in patients with cancer will be supported if daily wear time is ≥10 hours per day and ≥4 days per week

  Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)

• Number of participants who experienced adverse events during exercise testing, supervised exercise, or unsupervised exercise.

  Safety of physical activity will be assessed by recording the number of adverse events occurring during exercise testing, remotely supervised exercise training, and unsupervised exercise training. Adverse events will be recorded on a standardised data collection form

  Assessed 2 weeks post-surgery (T1), immediately after the 6-weeks of postoperative exercise (T2), and immediately after the 3 months follow up post exercise period (T3)

Secondary Outcomes (18)

• Change from baseline in Health Action Process Approach (HAPA) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period

  Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3)

• Change from baseline in Dyadic coping after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period

  Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3)

• Change from baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life (QLQ-BR23) after preoperative intervention and surgery, 6 weeks postoperative intervention, and a 3 month observation

  Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3)

• Change from baseline in European Organization for Research and Treatment of Cancer (EORTC) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period

  Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3)

• Change from baseline in BREAST-Q-Satisfaction after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period

  Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3)

Study Arms (1)

Exercise-based multi-phasic, multi-modal intervention

EXPERIMENTAL

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

Behavioral: Exercise-based multi-phasic, multi-modal intervention

Interventions

Exercise-based multi-phasic, multi-modal intervention 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

Exercise-based multi-phasic, multi-modal intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• University of Wolverhampton: collaborator
• University of Hull: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• University of Bath: collaborator
• Aston University: collaborator
• Staffordshire University: collaborator

Study Sites (1)

University Hospital Derby and Burton

Burton-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Amtul Carmichael

  University Hospitals of Derby and Burton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 13, 2023
• Study Start: June 16, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

GB (1)