How Breast Conservative Surgery (BCS) Affects Women's Daily Activities On Post-Operation 2 Days?
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | December 12, 2005 | ||||
| Last Updated Date | February 26, 2008 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00265213 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | How Breast Conservative Surgery (BCS) Affects Women's Daily Activities On Post-Operation 2 Days? | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | February 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00265213 | ||||
| Other Study ID Numbers ICMJE | KMUH-IRB-940194 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Kaohsiung Medical University Chung-Ho Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Kaohsiung Medical University Chung-Ho Memorial Hospital | ||||
| Verification Date | December 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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