Translation and validation of a questionnaire, named Breast Cancer and Lymphedema Experience Index (BCLE-SEI), from English to three Indian languages; Hindi, Marathi and Bengali. Additionally, to compare two bio-impedance spectroscopy devices which are used to measure arm swelling.
Not Applicable
- Conditions
- Health Condition 1: null- Women aged 18 years and above who have completed breast cancer treatment and in follow-up, with or without lymphedema
- Registration Number
- CTRI/2017/11/010326
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Women who have completed breast cancer treatment and in follow-up, with or without lymphedema
2. >18 years of age
3.Willing to give informed consent
4.Ability to fill the self-reported questionnaires in any of the four languages (English, Hindi Marathi and Bengali)
Exclusion Criteria
1.Significant cognitive impairment
2.Lymphedema due to reasons other than cancer treatment
3.Bilateral Breast Cancer
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Psychometric properties of translated BCLE-SEI questionnaire.Timepoint: After completion of primary cancer therapy and 4 to 7 days after the first visit for test - retest reliability.
- Secondary Outcome Measures
Name Time Method Extracellular fluid ratioTimepoint: After completion of primary cancer therapy, during their regular follow-up visits and 4 to 7 days after the first visit for test - retest reliability.