Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery
|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 ]
|Study Start Date:||August 2004|
|Study Completion Date:||December 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Prehabilitation (exercises pre surgery)
Exercise class pre-surgery
Active Comparator: 2
Usual care as provided by the institution
Other: Usual care
Exercise booklet, physiotherapy if needed
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170235
|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|