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

December 12, 2005
February 26, 2008
May 2005
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Complete list of historical versions of study NCT00265213 on ClinicalTrials.gov Archive Site
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How Breast Conservative Surgery (BCS) Affects Women's Daily Activities On Post-Operation 2 Days?
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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.

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.

Observational
Time Perspective: Prospective
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Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
February 2006
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Inclusion Criteria:

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

Exclusion Criteria:

  • total SPADI score is not zero
Female
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No
Contact: Ching Chun Lin, PT,CAS 886-7-3121101 ext 5961 jesipt@kmu.edu.tw
Taiwan
 
NCT00265213
KMUH-IRB-940194
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Kaohsiung Medical University Chung-Ho Memorial Hospital
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Principal Investigator: Ching Chun Lin, PT,CAS Rehabilitation department, Kaoshing Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP