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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

576 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-14

Study Completion Date

2021-12-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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localized disease or locally advanced disease

Subgroups:

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

No interventions assigned to this group

metastatic disease

Subgroups:

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

No interventions assigned to this group

follow up disease

Subgroups:

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No