NCT01230671

Brief Summary

Breast Cancer is the most common cancer amongst Canadian women. Studies report that breast cancer patients are the most likely to use complementary medicine within the oncologic population. Yoga has become especially popular with this group as it promises to improve the mind, body and soul holistically. The investigators yoga program specifically focuses on rebuilding physical strength, increasing flexibility and reducing the pain and stress associated with the post-operative period. This study will examine how yoga can help improve the overall quality of life and its effects on the physical well-being of women with breast cancer. With positive statistical results, the investigators hope to implement yoga as part of their rehabilitation services at the Cedars Breast Clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Aug 2010

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, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

3.2 years

First QC Date

October 27, 2010

Last Update Submit

October 24, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Range of motion of the shoulders

    The range of motion of the shoulders will be measured before and after the 12 week session and then compared.

    12 weeks

Secondary Outcomes (1)

  • Anxiety

    12 weeks

Study Arms (2)

Yoga

EXPERIMENTAL

Patients in this arm will receive yoga therapy

Other: Yoga

No yoga

PLACEBO COMPARATOR

Patients will not have yoga in this arm

Interventions

YogaOTHER

A 12 week yoga session will be offered to women with breast cancer.

Yoga

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages between 18-70
  • Stage I to II breast cancer
  • Minimum of 6 weeks Post Operative status

You may not qualify if:

  • Previous/Current psychiatric history
  • Concurrently involved in a yoga program
  • Inability to undergo yoga training secondary to physical/health limitations outlined by the treating team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedar's Breast Clinic, Royal Victoria Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Dean, Faculty of Medicine

Study Record Dates

First Submitted

October 27, 2010

First Posted

October 29, 2010

Study Start

August 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations