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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170235
• Other study ID #: SDR-05-017
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: September 3, 2010
• Start date: August 2004
• Est. completion date: December 2009

Study information

• Verified date: May 2008
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women

• Diagnosed with breast cancer

• Able to complete questionnaires

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Prehabilitation
Exercise class pre-surgery
• Usual care
Exercise booklet, physiotherapy if needed

Locations

Country	Name	City	State
Canada	Division of Clinical Epidemiology	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Canadian Breast Cancer Research Alliance

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Mayo NE, Scott SC, Shen N, Hanley J, Goldberg MS, MacDonald N. Waiting time for breast cancer surgery in Quebec. CMAJ. 2001 Apr 17;164(8):1133-8. — View Citation

Shen N, Mayo NE, Scott SC, Hanley JA, Goldberg MS, Abrahamowicz M, Tamblyn R. Factors associated with pattern of care before surgery for breast cancer in Quebec between 1992 and 1997. Med Care. 2003 Dec;41(12):1353-66. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	participation restriction		2 years	No