Clinical trial NCT05901142: Prehabilitation and RecOVERy From Surgery for Breast Cancer Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Exercise
Breast Neoplasm Female
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Wolverhampton
name: University of Hull
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: University of Bath
name: Aston University
name: Staffordshire University
First posted: 2023-06-13
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants recruited during the 36 week recruitment period
timeFrame: Assessed immediately after the 36 week recruitment period
measure: Number of participants retained during the interventional period
timeFrame: Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)
measure: 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.
timeFrame: Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)
measure: Number of participants who had an average daily wear time is ≥10 hours per day and ≥4 days per week
timeFrame: Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)
measure: Number of participants who experienced adverse events during exercise testing, supervised exercise, or unsupervised exercise.
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: Change from baseline in Dyadic coping after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Change from baseline in BREAST-Q-Satisfaction after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in WHO Disability Assessment Schedule V.2.0 after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in Shoulder pain and disability index (SPADI) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in Musculoskeletal Health Questionnaire (MSK-HQ) Schedule V.2.0 instrument after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in 6 minute walk test (6MWT) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in 30 second chair to stand (30CST) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in Hand Grip dynamometry after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in Shoulder range of motion (RoM) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in Lymphedema after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in Habitual Physical Activity (active minutes) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Change from baseline in 4 day food diary after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period
timeFrame: 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)
measure: Number of participants who experienced treatment-related adverse events (AEs)
timeFrame: 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)
measure: Chemotherapy completion rate
timeFrame: Assessed immediately after the 6-weeks of postoperative exercise (T2), and immediately after the 3 months follow up post exercise period (T3)
measure: Focus groups
timeFrame: Assessed immediately after the 6-weeks of postoperative exercise (T2), and immediately after the 3 months follow up post exercise period (T3)
Other outcomes:
Locations:
city: Burton Upon Trent
country: United Kingdom
facility: University Hospital Derby and Burton
Study officials:
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
name: Amtul Carmichael
role: PRINCIPAL_INVESTIGATOR
References: