Prehabilitation for Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Prehabilitation Program Based on Health Education and Nordic Walking to Reduce Musculoskeletal Impairments in Women Undergoing Breast Cancer Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Group-based Nordic Walking Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention | |
| Experimental: Prehabilitation<br>Patients allocated to this arm will participate in a weekly group-based exercise intervention (nordic walking) and receive health education through a booklet, videos of the exercises and face-to-face sessions prior to each nordic walking session. Chemotherapy will continue as scheduled. | Behavioral: Group-based Nordic Walking Exercise Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH) | 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) | Pre-Surgery (one week) | 
| Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH) | 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) | One month post-surgery | 
| Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH) | 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) | Three months post-surgery | 
| Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH) | 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) | Six months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper arm volume | Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level | Pre-Surgery (one week) | 
| Upper arm volume | Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level | One month post-surgery | 
| Upper arm volume | Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level | Three months post-surgery | 
| Upper arm volume | Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level | Six months post-surgery | 
| Range of Movement (ROM) | Range of movement of the affected arm in three axes using a goniometer | Pre-Surgery (one week) | 
| Range of Movement (ROM) | Range of movement of the affected arm in three axes using a goniometer | One month post-surgery | 
| Range of Movement (ROM) | Range of movement of the affected arm in three axes using a goniometer | Three months post-surgery | 
| Range of Movement (ROM) | Range of movement of the affected arm in three axes using a goniometer | Six months post-surgery | 
| Pain severity | Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain) | Pre-Surgery (one week) | 
| Pain severity | Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain) | One month post-surgery | 
| Pain severity | Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain) | Three months post-surgery | 
| Pain severity | Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain) | Six months post-surgery | 
| Health-Related Quality of Life | 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 | Pre-Surgery (one week) | 
| Health-Related Quality of Life | 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 | One month post-surgery | 
| Health-Related Quality of Life | HHealth-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 | Three months post-surgery | 
| Health-Related Quality of Life | 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 | Six months post-surgery | 
| Handgrip Strength | 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. | Pre-Surgery (one week) | 
| Handgrip Strength | 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. | One month post-surgery | 
| Handgrip Strength | 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. | Three months post-surgery | 
| Handgrip Strength | 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. | Six months post-surgery | 
| Functional capacity | Functional capacity will be measured with the distance covered by the 6-Minute Walk Test. | Pre-surgery (one week) | 
| Functional capacity | Functional capacity will be measured with the distance covered by the 6-Minute Walk Test. | One month post-surgery | 
| Functional capacity | Functional capacity will be measured with the distance covered by the 6-Minute Walk Test. | Three months post-surgery | 
| Functional capacity | Functional capacity will be measured with the distance covered by the 6-Minute Walk Test. | Six months post-surgery | 
| Adherence | Adherence to the scheduled sessions will be registered in the Prehab group and will be reported as percentage of attended vs. scheduled. | Pre-Surgery (one week) | 
| Physical Activity | 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. | Pre-surgery (one week) | 
| Physical Activity | 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. | One month post-surgery | 
| Physical Activity | 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. | Three months post-surgery | 
| Physical Activity | 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. | Six months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, prehabilitation, exercise therapy