Prehabilitation for Breast Cancer Surgery

NCT05216302 | Completed

• 1 other identifier: IIBSP-PRO-2021-10
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; prehabilitation; exercise therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (29)

• Upper arm volume

  Pre-Surgery (one week)

• Upper arm volume

  One month post-surgery

• Upper arm volume

  Three months post-surgery

• Upper arm volume

  Six months post-surgery

• Range of Movement (ROM)

  Pre-Surgery (one week)

Study Arms (2)

Usual Care

NO INTERVENTION

Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention

Prehabilitation

EXPERIMENTAL

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

Interventions

Group-based Nordic Walking Exercise Program BEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Raquel Sebio: lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Related Publications (5)

• 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.

  PMID: 28942905 BACKGROUND

• 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.

  PMID: 16818906 BACKGROUND

• 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.

  PMID: 23756434 BACKGROUND

• 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.

  PMID: 29683834 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Raquel Sebio, PhD

  School of Health Sciences TecnoCampus. University Pompeu Fabra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: January 10, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

ES (1)