Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: Prehabilitation Other: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Reducing Arm Morbidity Through Physical Therapy Provided Pre- and Post-breast Cancer Surgery |
- participation restriction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | August 2004 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Prehabilitation (exercises pre surgery)
|
Other: Prehabilitation
Exercise class pre-surgery
|
|
Active Comparator: 2
Usual care as provided by the institution
|
Other: Usual care
Exercise booklet, physiotherapy if needed
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women
- Diagnosed with breast cancer
- Able to complete questionnaires
Exclusion Criteria:
- none
Contacts and Locations| Canada, Quebec | |
| Division of Clinical Epidemiology | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Principal Investigator: | Nancy Mayo, PhD | James McGill Professor, Department of Medicine, School of Physical and Occupational Therapy, McGill University |
More Information
Publications:
| Responsible Party: | Dr Nancy Mayo, McGill University |
| ClinicalTrials.gov Identifier: | NCT00170235 History of Changes |
| Other Study ID Numbers: | SDR-05-017 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 3, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McGill University:
|
Breast cancer Prehabilitation Rehabilitation Exercise |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013