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Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prehabilitation
Usual care
Sponsored by
McGill University
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, Rehabilitation, Exercise

Eligibility Criteria

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

Inclusion Criteria: Women Diagnosed with breast cancer Able to complete questionnaires Exclusion Criteria: none

Sites / Locations

  • Division of Clinical Epidemiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Prehabilitation (exercises pre surgery)

Usual care as provided by the institution

Outcomes

Primary Outcome Measures

participation restriction

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
September 3, 2010
Sponsor
McGill University
Collaborators
Canadian Breast Cancer Research Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT00170235
Brief Title
Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery
Official Title
Reducing Arm Morbidity Through Physical Therapy Provided Pre- and Post-breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
McGill University
Collaborators
Canadian Breast Cancer Research Alliance

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall aim of this pilot study is to explore the feasibility of a randomized trial to test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing arm morbidity and increasing health-related quality of life (HRQL) post-surgery.
Detailed Description
Breast cancer surgery is one of the most frightening health events a woman can experience. Not only is there fear of cancer and mortality, but also fear of disfigurement and disability arising from the surgery and from the subsequent chemotherapy and radiotherapy. The pre-operative period is a time of great anxiety and in the post-operative period this anxiety is compounded by pain and discomfort associated with the breast and axillary wounds. Lack of knowledge about follow-up treatment leads to fear and anxiety post-surgery. All women experience loss of mobility and function of the arm on the operative side for a period of time ranging from days to months to years. This arm morbidity interferes with participation in usual activities, is an additional source of stress compounding the psychological distress associated with the cancer itself, and has a negative impact on the quality of life. The post-operative period may not be the most opportune time to introduce interventions to accelerate recovery. Many women will be concerned about perturbing the healing process and may be depressed and anxious as they await extra treatment for the tumor. The pre-operative period may be a more emotionally salient time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual to enable him or her to withstand stressors is termed "prehabilitation". This project deals with the effectiveness of prehabilitation with or without post-operative exercise to reduce arm morbidity and increase quality of life following breast cancer surgery. The overall aim is to explore the feasibility of a randomized trial to test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing arm morbidity and increasing health-related quality of life (HRQL) post-surgery. The specific objectives of this pilot project are to: estimate recruitment rates for such a trial; estimate compliance to the protocols; pilot the randomization procedures; identify sub-groups of the population with different needs for pre-and post-surgical physical therapy; estimate effect sizes to be used for sample size calculations for the main project and for budget justification.

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, Rehabilitation, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Prehabilitation (exercises pre surgery)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual care as provided by the institution
Intervention Type
Other
Intervention Name(s)
Prehabilitation
Intervention Description
Exercise class pre-surgery
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Exercise booklet, physiotherapy if needed
Primary Outcome Measure Information:
Title
participation restriction
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women Diagnosed with breast cancer Able to complete questionnaires Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Mayo, PhD
Organizational Affiliation
James McGill Professor, Department of Medicine, School of Physical and Occupational Therapy, McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Clinical Epidemiology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11338798
Citation
Mayo NE, Scott SC, Shen N, Hanley J, Goldberg MS, MacDonald N. Waiting time for breast cancer surgery in Quebec. CMAJ. 2001 Apr 17;164(8):1133-8.
Results Reference
background
PubMed Identifier
14668668
Citation
Shen N, Mayo NE, Scott SC, Hanley JA, Goldberg MS, Abrahamowicz M, Tamblyn R. Factors associated with pattern of care before surgery for breast cancer in Quebec between 1992 and 1997. Med Care. 2003 Dec;41(12):1353-66. doi: 10.1097/01.MLR.0000100581.88722.6C.
Results Reference
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Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery

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