Prehabilitation for Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216302
• Other study ID #: IIBSP-PRO-2021-10
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: July 2023
• Source: Universitat Pompeu Fabra
• Contact: Anabel Casanovas Álvarez, MSc
• Phone: +34931696573
• Email: acasanovasa[@]tecnocampus.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Raquel Sebio	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Range of Movement (ROM)	Range of movement of the affected arm in three axes using a goniometer	Pre-Surgery (one week)
Secondary	Range of Movement (ROM)	Range of movement of the affected arm in three axes using a goniometer	One month post-surgery
Secondary	Range of Movement (ROM)	Range of movement of the affected arm in three axes using a goniometer	Three months post-surgery
Secondary	Range of Movement (ROM)	Range of movement of the affected arm in three axes using a goniometer	Six months post-surgery
Secondary	Pain severity	Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)	Pre-Surgery (one week)
Secondary	Pain severity	Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)	One month post-surgery
Secondary	Pain severity	Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)	Three months post-surgery
Secondary	Pain severity	Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)	Six months post-surgery
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional capacity	Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.	Pre-surgery (one week)
Secondary	Functional capacity	Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.	One month post-surgery
Secondary	Functional capacity	Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.	Three months post-surgery
Secondary	Functional capacity	Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.	Six months post-surgery
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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