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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    490
  • sponsor
    Helios University Hospital Wuppertal
Updated on 2 March 2021
metastasis

Summary

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.

Details
Condition Breast Cancer, Quality of life, Breast Cancer Diagnosis, breast carcinoma, cancer, breast, quality-of-life
Clinical Study IdentifierNCT04018235
SponsorHelios University Hospital Wuppertal
Last Modified on2 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Breast Cancer or Quality of life?
Do you have any of these conditions: Breast Cancer or Quality of life or breast carcinoma or Breast Cancer Diagnosis or quality-of-life or cancer, breast?
Do you have any of these conditions: Quality of life or cancer, breast or quality-of-life or Breast Cancer Diagnosis or Breast Cancer or breast carcinoma?
Do you have any of these conditions: breast carcinoma or Breast Cancer or cancer, breast or quality-of-life or Quality of life or Breast Cancer Diagnosis?
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
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
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