A study to analyse a questionnaire which assesses quality of life in breast cancer patients

An international Phase 4 field study to analyse the psychometric properties of the updated module on assessing quality of life of patients with breast cancer (EORTC QLQ-BR23 Update EORTC QLQ BR45). - EORTC BR45

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/05/033568

Enrollment

500

Registered

2021-05-12

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: C506- Malignant neoplasm of axillary tail of breast Health Condition 2: C508- Malignant neoplasm of overlappingsites of breast

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed diagnosis of breast cancer. 2) No previous primary or recurrent tumor. 3) Ability to understand the language of the questionnaire. 4) Mental fitness to complete a questionnaire. 5) Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria are the negation of the inclusion criteria i.e., no histologically confirmed diagnosis of breast cancer, previous primary or recurrent tumor, not mentally fit to complete a questionnaire, not able to understand the language of the questionnaire, younger than 18, and refusal of informed consent.

Design outcomes

Primary

Measure	Time frame
To test the the psychometric properties of the EORTC QLQ- BR45 in patients diagnosed with breast cancer. This includes the scale structure, reliability, validity, and responsiveness to change of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30.Timepoint: On the day of enrolment in the study patients will be asked to complete the questionnaire.	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

Austria, Belgium, Brazil, Croatia, Ethiopia, France, Germany, India, Israel, Italy, Japan, Jordan, Netherlands, Norway, Poland, Spain, Switzerland, Taiwan, United Kingdom

Contacts

Public ContactDr Manjunath Nookala Krishnamurthy

Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

nk.manjunath@gmail.com919920703438

Outcome results

None listed

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