Clinical trial NCT00265213: How Breast Conservative Surgery (BCS) Affects Women's Daily Activities On Post-Operation 2 Days?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast conservative surgery
shoulder functional outcome questionnaire
disability questionnaire
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2005-12-14
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* total SPADI score is not zero

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Rehabilitation department,Kaoshing Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Rehabilitation department, Kaoshing Medical University Chung-Ho Memorial Hospital
name: Ching Chun Lin, PT,CAS
role: PRINCIPAL_INVESTIGATOR
References: