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Completed

NCT Number: NCT00170235

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of Clinical Epidemiology

Montreal, Quebec, H3A 1A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Prehabilitation

Other

Exercise class pre-surgery

Usual Care

Other

Exercise booklet, physiotherapy if needed

Primary outcomes

  1. participation restriction

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Canadian Breast Cancer Research Alliance

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
Sep 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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