NCT04018235

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

July 10, 2019

Last Update Submit

July 18, 2022

Conditions

Breast CancerQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Psychometric Properties of the EORTC QLQ-BR45

    Psychometric Properties of the EORTC QLQ-BR45 (scale structure, reliability, internal consistency, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer)

    baseline and for some patients 1-2 weeks later (test-retest) or 3 month later (responsiveness-to-change)

Study Arms (3)

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

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

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study sample will be composed of a series of consecutive cancer patients who meet the study eligibility criteria in each participating centre

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke

Wuppertal, 42283, Germany

Location

Related Publications (2)

  • Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.

    PMID: 8874337BACKGROUND

  • Bjelic-Radisic V, Cardoso F, Cameron D, Brain E, Kuljanic K, da Costa RA, Conroy T, Inwald EC, Serpentini S, Pinto M, Weis J, Morag O, Lindviksmoen Astrup G, Tomaszweksi KA, Pogoda K, Sinai P, Sprangers M, Aaronson N, Velikova G, Greimel E, Arraras J, Bottomley A; EORTC Quality of Life Group and Breast Cancer Group. An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45. Ann Oncol. 2020 Feb;31(2):283-288. doi: 10.1016/j.annonc.2019.10.027. Epub 2019 Dec 18.

    PMID: 31959345BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Vesna Bjelic-Radisic

    Helios Universitiätsklinikum Wuppertal, Universität Witten/Herdecke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 12, 2019

Study Start

June 14, 2019

Primary Completion

December 17, 2021

Study Completion

December 17, 2021

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)