How Breast Conservative Surgery (BCS) Affects Women's Daily Activities On Post-Operation 2 Days?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00265213
First received: December 12, 2005
Last updated: February 26, 2008
Last verified: December 2005
  Purpose

we revise 8 disability items from SPADI into Chinese to develop a simple self-completion questionnaire for the assessment of restriction in daily activities resulting from breast conservative surgery.

The purpose of this study was to validate the score obtained from this questionnaire by testing restriction of shoulder active flexion and abduction on examination at post BCS 2 days correlates with disability score.


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Estimated Enrollment: 30
Study Start Date: May 2005
Estimated Study Completion Date: February 2006
Detailed Description:

Breast-conserving therapy (BCT) is a breast cancer treatment using breast conservative surgery(BCS) with lymph node dissection and with or without following by radiotherapy(RT). (Morrow,2004). Results of BCTs demonstrate high rates of local tumor control with satisfactory cosmetic results. (Morrow,2004) Nowadays, the local treatment of breast cancer has slowly accepted from radical mastectomy with lymph node dissection to (BCT) in the last 100 years. (Morrow,2004) After surgical intervention for breast cancer carcinoma, the most frequent morbilities are lymphedema of the unilateral upper extremity and shoulder dysfunction. (Wingate L,1985; Grube, 2004)From the perspective of the Institute of Medicine's(IOM), the outcome measures shifts from the impairment-based measures to functional limitation measures. (Jette AM,1995) Base on the third element in Donabedian's framework of quality of physical therapy care, the determination of outcomes in terms of death, morbidity, disability, or quality of life. (Jette AM,1995)Although shoulder active range-of-motion exercises could start at the day right after any type or level of lymph node dissections for breast cancer patients, (Staradub VL, 2004;Wingate L,1985) in my literature review results, no functional evaluation questionnaires that was sensitive enough to detect the disabilities resulting from lymph node dissections at post BCS 2 days. So we revise 8 disability items from SPADI into Chinese to develop a simple self-completion questionnaire for the assessment of restriction in daily activities resulting from breast conservative surgery.

The purpose of this study was to validate the score obtained from this questionnaire by testing restriction of shoulder active flexion and abduction on examination at post BCS 2 days correlates with disability score.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post breast conservative surgery 2 days
  • with lymph node dissection

Exclusion Criteria:

  • total SPADI score is not zero
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265213

Contacts
Contact: Ching Chun Lin, PT,CAS 886-7-3121101 ext 5961 jesipt@kmu.edu.tw

Locations
Taiwan
Rehabilitation department,Kaoshing Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Ching Chun Lin, PT,CAS    886-7-3121101 ext 5961    jesipt@kmu.edu.tw   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Ching Chun Lin, PT,CAS Rehabilitation department, Kaoshing Medical University Chung-Ho Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00265213     History of Changes
Other Study ID Numbers: KMUH-IRB-940194
Study First Received: December 12, 2005
Last Updated: February 26, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
breast conservative surgery
shoulder functional outcome questionnaire
disability questionnaire

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014