Breast Cancer
Conditions
Keywords
breast cancer, prehabilitation, exercise therapy
Brief summary
Prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. However, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery. To this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm. The study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. Women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (UC) or prehabilitation (PREHAB). Patients will be assessed for eligibility during the fourth out of six course of chemotherapy. Those randomised to the PREHAB group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). In addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. Patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively.
Interventions
BEHAVIORALGroup-based Nordic Walking Exercise Program
An exercise intervention based on nordic walking and health education of one hour and 15 minutes per session. Each session includes 10 min of health education followed by 15 minutes of warm-up exercises, 30 minutes of nordic walking and finally 15 min to cool-down. The intervention is meant to last during two months (last round of chemotherapy and one month pre-surgery), twice weekly for approximately a total of 16 sessions.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Raquel Sebio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy * Candidates to receive neoadjuvant chemotherapy * Not currently undergoing any other physical therapy therapies or treatments
Exclusion criteria
* Cognitive impairment or inability to read Catalan or Spanish * Prior diagnosis of shoulder impairment or injury * Major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH) | Pre-Surgery (one week) | Functionality of the affected upper arm using the DASH questionnaire. The questionnaire compromises 11 items. Scoring ranges from 0 (no disability) to 100 (more severe disability) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Movement (ROM) | Pre-Surgery (one week) | Range of movement of the affected arm in three axes using a goniometer |
| Pain severity | Pre-Surgery (one week) | Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain) |
| Health-Related Quality of Life | Pre-Surgery (one week) | Health-Related Quality of Life will be assessed with the questionnaire developed by the European Organization for Research and Treatment (EORTC) Quality of Life (QLQ) questionnaire (EORTC QLQ C30). Scores range from 0 to 100 with higher values associated with better overall quality of life |
| Upper arm volume | Pre-Surgery (one week) | Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level |
| Functional capacity | Pre-surgery (one week) | Functional capacity will be measured with the distance covered by the 6-Minute Walk Test. |
| Adherence | Pre-Surgery (one week) | Adherence to the scheduled sessions will be registered in the Prehab group and will be reported as percentage of attended vs. scheduled. |
| Physical Activity | Pre-surgery (one week) | Physical activity levels will be measured using the short form of the International Physical Activity Questionnaire (IPAQ). Estimated METS per week will be calculated based on the available formulas. |
| Handgrip Strength | Pre-Surgery (one week) | Handgrip strength will be determined using an hydraulic dynamometer (Jamar). Both hands will be assessed and the better result out of three attempts will be used. |
Countries
Spain
Outcome results
None listed