Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer (EORTCQLQBR45)

Helios University Hospital Wuppertal

Status: Completed

Conditions: Breast Cancer; Quality of Life

Study type: Observational

Funder types: Other

Identifiers

NCT04018235

EORTC QLQ BR45

Details and patient eligibility

About

Females breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC QLG decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies.

The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer. Participants will be enrolled in three groups according to their disease stage (1. localized disease or locally advanced disease, 2. metastatic disease, 3. follow up). Various combinations of therapies are permissible, resulting in a total of 17 subgroups.

Enrollment: 576 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed diagnosis of breast cancer
• no previous primary or recurrent tumour
• ability to understand the language of the questionnaire
• mental fitness to complete a questionnaire
• 18 years of age or above
• written informed consent.

Exclusion criteria

• no histologically confirmed diagnosis of breast cancer
• previous primary or recurrent tumour
• not mentally fit to complete a questionnaire
• not able to understand the language of the questionnaire
• younger than 18
• refusal of informed consent

Trial design

576 participants in 3 patient groups

localized disease or locally advanced disease

Description:

Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy

metastatic disease

Description:

Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery

follow up disease

Description:

Subgroups: A: BCT/Ablatio + /-SN Biopsie + /- Irradiation B: BCT/Ablatio + axill Diss C: Chemotherapy D: Antihormonal Therapy E: Target Therapy F: No Surgery