Prehabilitation for Breast Cancer Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Group-based Nordic Walking Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anabel Casanovas Álvarez, MSc; Phone Number: 10340 +34931696573; Email: acasanovasa@tecnocampus.cat
• Study Contact Backup: Name: Raquel Sebio, PhD; Email: rsebio@tecnocampus.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital Santa Creu i Sant Pau
    • Contact: Jaume Masià, PhD; Phone Number: +34935565775; Email: JMasia@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention
Experimental: Prehabilitation; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Raquel Sebio
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Study Director: Raquel Sebio, PhD, School of Health Sciences TecnoCampus. University Pompeu Fabra

Publications and helpful links

General Publications

• McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
• Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
• Santa Mina D, Brahmbhatt P, Lopez C, Baima J, Gillis C, Trachtenberg L, Silver JK. The Case for Prehabilitation Prior to Breast Cancer Treatment. PM R. 2017 Sep;9(9S2):S305-S316. doi: 10.1016/j.pmrj.2017.08.402.
• Yang A, Sokolof J, Gulati A. The effect of preoperative exercise on upper extremity recovery following breast cancer surgery: a systematic review. Int J Rehabil Res. 2018 Sep;41(3):189-196. doi: 10.1097/MRR.0000000000000288.
• ILokapavani Y, Krishna SR, Madhavi K. nfluence of Pre - Operative Physical Therapy Education and Exercise on Post-operative Shoulder Range of Motion and Functional Activites in Subjects with Modified Radical Mastectomy. Int J Physiother 2014. DOI: 10.15621/ijphy/2014/v1i4/54556

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; prehabilitation; exercise therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IIBSP-PRO-2021-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No