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CompletedNCT00170235Updated Sep 6, 2010

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

An interventional study of Prehabilitation and Usual care in Breast Cancer, sponsored by McGill University. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-06.

Sponsored by McGill University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • Prehabilitation
  • Rehabilitation
  • Exercise
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    1

    Prehabilitation (exercises pre surgery)

    Other: Prehabilitation

  • Active comparator
    2

    Usual care as provided by the institution

    Other: Usual care

Interventions

  • OtherPrehabilitation

    Exercise class pre-surgery

  • OtherUsual care

    Exercise booklet, physiotherapy if needed

06

What researchers measure

Primary outcomes

  1. participation restriction

    Time frame: 2 years

07

Study locations

1 site
  • Division of Clinical Epidemiology
    Montreal, Quebec H3A 1A1, Canada
08

References and documents

Publications

  • 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. PubMed 11338798 ↗
  • 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. doi: 10.1097/01.MLR.0000100581.88722.6C. PubMed 14668668 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00170235
Lead sponsor
McGill University
Collaborators
Canadian Breast Cancer Research Alliance
First posted
Sep 15, 2005
Start date
Aug 2004
Primary completion
Jul 2009
Completion
Dec 2009
Last update
Sep 6, 2010

Study contacts

Nancy Mayo, PhD
principal investigator · James McGill Professor, Department of Medicine, School of Physical and Occupational Therapy, McGill University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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