- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170235
Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery
Reducing Arm Morbidity Through Physical Therapy Provided Pre- and Post-breast Cancer Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- Division of Clinical Epidemiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women
- Diagnosed with breast cancer
- Able to complete questionnaires
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Prehabilitation (exercises pre surgery)
|
Exercise class pre-surgery
|
Active Comparator: 2
Usual care as provided by the institution
|
Exercise booklet, physiotherapy if needed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
participation restriction
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy Mayo, PhD, James McGill Professor, Department of Medicine, School of Physical and Occupational Therapy, McGill University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDR-05-017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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