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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Prehabilitation; Other: Usual care

• Registration Number: NCT00170235
• Lead Sponsor: McGill University

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:

1. estimate recruitment rates for such a trial;

2. estimate compliance to the protocols;

3. pilot the randomization procedures;

4. identify sub-groups of the population with different needs for pre-and post-surgical physical therapy;

5. estimate effect sizes to be used for sample size calculations for the main project and for budget justification.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Status Verified: 2008-05
• Primary Completion: 2009-07
• Study Completion: 2009-12
• Last Update Submitted: 2010-09-03
• Last Update Posted: 2010-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women
• Diagnosed with breast cancer
• Able to complete questionnaires

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Prehabilitation	Prehabilitation (exercises pre surgery)
2	Usual care	Usual care as provided by the institution

Primary Outcome Measures

Name	Time	Method
participation restriction	2 years

Trial Locations

Locations (1)

Division of Clinical Epidemiology; 🇨🇦 Montreal, Quebec, Canada