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Prehabilitation for Breast Cancer Surgery

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group-based Nordic Walking Exercise Program
Sponsored by
Raquel Sebio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, prehabilitation, exercise therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Prehabilitation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

Upper arm volume
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Upper arm volume
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Upper arm volume
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Upper arm volume
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Range of Movement (ROM)
Range of movement of the affected arm in three axes using a goniometer
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Pain severity
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
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
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
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
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
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.
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.
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.
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.
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Functional capacity
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Adherence
Adherence to the scheduled sessions will be registered in the Prehab group and will be reported as percentage of attended vs. scheduled.
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.
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.
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.
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.

Full Information

First Posted
January 18, 2022
Last Updated
July 27, 2023
Sponsor
Raquel Sebio
Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT05216302
Brief Title
Prehabilitation for Breast Cancer Surgery
Official Title
Prehabilitation Program Based on Health Education and Nordic Walking to Reduce Musculoskeletal Impairments in Women Undergoing Breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raquel Sebio
Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, prehabilitation, exercise therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients allocated to this arm will continue with their schedule chemotherapy with no additional intervention
Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group-based Nordic Walking Exercise Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Description
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)
Time Frame
Pre-Surgery (one week)
Title
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Description
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)
Time Frame
One month post-surgery
Title
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Description
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)
Time Frame
Three months post-surgery
Title
Disabilities of the Arm Shoulder and Hand Questionnaire (Quick DASH)
Description
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)
Time Frame
Six months post-surgery
Secondary Outcome Measure Information:
Title
Upper arm volume
Description
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Time Frame
Pre-Surgery (one week)
Title
Upper arm volume
Description
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Time Frame
One month post-surgery
Title
Upper arm volume
Description
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Time Frame
Three months post-surgery
Title
Upper arm volume
Description
Perimeter of the affected arm will be measured with a tape measure at hand, wrist, elbow and shoulder level
Time Frame
Six months post-surgery
Title
Range of Movement (ROM)
Description
Range of movement of the affected arm in three axes using a goniometer
Time Frame
Pre-Surgery (one week)
Title
Range of Movement (ROM)
Description
Range of movement of the affected arm in three axes using a goniometer
Time Frame
One month post-surgery
Title
Range of Movement (ROM)
Description
Range of movement of the affected arm in three axes using a goniometer
Time Frame
Three months post-surgery
Title
Range of Movement (ROM)
Description
Range of movement of the affected arm in three axes using a goniometer
Time Frame
Six months post-surgery
Title
Pain severity
Description
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Time Frame
Pre-Surgery (one week)
Title
Pain severity
Description
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Time Frame
One month post-surgery
Title
Pain severity
Description
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Time Frame
Three months post-surgery
Title
Pain severity
Description
Global pain assessed with a Visual Analog Scale (0 no pain to 10 maximum pain)
Time Frame
Six months post-surgery
Title
Health-Related Quality of Life
Description
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
Time Frame
Pre-Surgery (one week)
Title
Health-Related Quality of Life
Description
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
Time Frame
One month post-surgery
Title
Health-Related Quality of Life
Description
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
Time Frame
Three months post-surgery
Title
Health-Related Quality of Life
Description
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
Time Frame
Six months post-surgery
Title
Handgrip Strength
Description
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.
Time Frame
Pre-Surgery (one week)
Title
Handgrip Strength
Description
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.
Time Frame
One month post-surgery
Title
Handgrip Strength
Description
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.
Time Frame
Three months post-surgery
Title
Handgrip Strength
Description
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.
Time Frame
Six months post-surgery
Title
Functional capacity
Description
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Time Frame
Pre-surgery (one week)
Title
Functional capacity
Description
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Time Frame
One month post-surgery
Title
Functional capacity
Description
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Time Frame
Three months post-surgery
Title
Functional capacity
Description
Functional capacity will be measured with the distance covered by the 6-Minute Walk Test.
Time Frame
Six months post-surgery
Title
Adherence
Description
Adherence to the scheduled sessions will be registered in the Prehab group and will be reported as percentage of attended vs. scheduled.
Time Frame
Pre-Surgery (one week)
Title
Physical Activity
Description
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.
Time Frame
Pre-surgery (one week)
Title
Physical Activity
Description
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.
Time Frame
One month post-surgery
Title
Physical Activity
Description
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.
Time Frame
Three months post-surgery
Title
Physical Activity
Description
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.
Time Frame
Six months post-surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anabel Casanovas Álvarez, MSc
Phone
+34931696573
Ext
10340
Email
acasanovasa@tecnocampus.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Sebio, PhD
Email
rsebio@tecnocampus.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Sebio, PhD
Organizational Affiliation
School of Health Sciences TecnoCampus. University Pompeu Fabra
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaume Masià, PhD
Phone
+34935565775
Email
JMasia@santpau.cat

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28942905
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.
Results Reference
background
PubMed Identifier
16818906
Citation
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.
Results Reference
background
PubMed Identifier
23756434
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.
Results Reference
background
PubMed Identifier
29683834
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.
Results Reference
background
Citation
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
Results Reference
background

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Prehabilitation for Breast Cancer Surgery

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