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

18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

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.

Inclusion Criteria:

- Women

- Diagnosed with breast cancer

- Able to complete questionnaires

Exclusion Criteria:

- none

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

participation restriction

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Nancy Mayo, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James McGill Professor, Department of Medicine, School of Physical and Occupational Therapy, McGill University


Canada: Ethics Review Committee

Study ID:




Start Date:

August 2004

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Prehabilitation
  • Rehabilitation
  • Exercise
  • Breast Neoplasms