NCT00170235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 6, 2010

Status Verified

May 1, 2008

Enrollment Period

4.9 years

First QC Date

September 9, 2005

Last Update Submit

September 3, 2010

Conditions

Breast Cancer

Keywords

Breast cancerPrehabilitationRehabilitationExercise

Outcome Measures

Primary Outcomes (1)

  • participation restriction

    2 years

Study Arms (2)

1

EXPERIMENTAL

Prehabilitation (exercises pre surgery)

Other: Prehabilitation

2

ACTIVE COMPARATOR

Usual care as provided by the institution

Other: Usual care

Interventions

PrehabilitationOTHER

Exercise class pre-surgery

1
Usual careOTHER

Exercise booklet, physiotherapy if needed

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Clinical Epidemiology

Montreal, Quebec, H3A 1A1, Canada

Location

Related 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.

    PMID: 11338798BACKGROUND

  • 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.

    PMID: 14668668BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nancy Mayo, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

August 1, 2004

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

September 6, 2010

Record last verified: 2008-05

Locations

CA(1)