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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Arm Morbidity Through Physical Therapy Provided Pre- and Post-breast Cancer Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Prehabilitation
* Other: Usual care


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Prehabilitation (exercises pre surgery) | Other: Prehabilitation<br>* Exercise class pre-surgery<br>|
| Active Comparator: 2<br>Usual care as provided by the institution | Other: Usual care<br>* Exercise booklet, physiotherapy if needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| participation restriction |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Prehabilitation, Rehabilitation, Exercise