The Effects of Pre-operative Physical Therapy Education

Breast Cancer Clinical Trial

Official title:

Phase 1 of the The Effects of Pre-operative Physical Therapy Education and Exercise on Patient Outcomes Post Breast Cancer Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01669187
• Other study ID #: OU-4824
• Status: Withdrawn
• Phase: N/A
• First received: July 20, 2012
• Last updated: April 9, 2014
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2014
• Source: Oakland University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

It is expected that patients who receive physical therapy before surgery will have greater range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety following surgery compared to those in the control group.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be over the age of 18,

• have a good understanding of the English language, and

• be scheduled to undergo either a mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.

Exclusion Criteria:

• if they previously underwent one of the previously mentioned procedures mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Education brochure

• Live education and exercise instruction
Participants will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program.

Locations

Country	Name	City	State
United States	St-Mary's of Michigan	Saginaw	Michigan
United States	St. Mary's of Michigan	Saginaw	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Oakland University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in other physical therapy test and measures	6 minute walk test; presence of cording; number of patient reported medical complications; shoulder strength measured by a dynamometer; Arm lymphedema measured by volumeter; Anxiety, general functional abilities, and QOL will be measured by the Functional Assessment of Cancer Therapy- Breast Cancer (FACT-B); Patient satisfaction will be measured using a 5 point Likert Scale.	Once pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery	No
Primary	Change in score for Shoulder Pain and Disability Index (SPADI)	Functional outcome measure questionnaire	Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively	No
Secondary	Change in Shoulder range of motion with goniometer		Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively	Yes