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Open (Enrolling)
Female
Breast Cancer

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Trial Information


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.


Inclusion Criteria:



- post breast conservative surgery 2 days

- with lymph node dissection

Exclusion Criteria:

- total SPADI score is not zero

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Ching Chun Lin, PT,CAS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rehabilitation department, Kaoshing Medical University Chung-Ho Memorial Hospital

Authority:

Taiwan: Department of Health

Study ID:

KMUH-IRB-940194

NCT ID:

NCT00265213

Start Date:

May 2005

Completion Date:

February 2006

Related Keywords:

  • Breast Cancer
  • breast conservative surgery
  • shoulder functional outcome questionnaire
  • disability questionnaire
  • Breast Neoplasms

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