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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.

Cross cultural adaptation of the Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) in three Indian language; Hindi, Marathi and Bengali and comparison of bio-impedance spectroscopy devices.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/11/010326
Enrollment
510
Registered
2017-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

None listed

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Significant cognitive impairment 2.Lymphedema due to reasons other than cancer treatment 3.Bilateral Breast Cancer

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

India

Contacts

Public ContactDr Anuradha Abhijeet Daptardar

Tata Memorial Hospital

vinsu24@gmail.com9967414286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026