EORTC Quality of Life Measurement in Males With Breast Cancer

NCT07455110 | Completed

• 1 other identifier: 002-2019
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Around 1% of all new cases of breast cancer (BC) diagnosed annually occur in men. Most research to date has focused on female breast cancer (FBC). So what is known about breast cancer in men has been mostly derived from the research and treatment of FBC. Comprehensive, prospective data about Quality of life in men treated for BC is lacking. Therefore, a validated worldwide questionnaire for male BC will be developed.

Conditions

Male Breast Cancer; Quality of Life; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Relevance

  Mean item relevance score (range 1-4; 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) on a study-specific issue list developed to identify quality of life issues in male breast cancer patients. Participants rate the extent to which they experienced each issue during the specified recall period (past 7 days or past 4 weeks, depending on item specification). Higher scores indicate greater perceived relevance of the issue.

  Single assessment at study enrollment (issues rated with recall period of the past 7 days or past 4 weeks, depending on item specification)

• Importance

  Percentage of participants selecting each issue for inclusion in a male breast cancer-specific quality of life questionnaire. Participants are instructed to select approximately 25% (±5%) of issues (approximately 11-17 items) that they consider most important for assessing quality of life. Item selection frequency will be used to inform item retention decisions.

  Single assessment at study enrollment

Interventions

structured Interview BEHAVIORAL

Interviews with patients and health care professionals(HCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Interviews with patients, who meet the eligibility criteria will be undertaken to get information on the most relevant issues influencing QoL. Also HCP with special knowledge in the field will be interviewed to discuss and consider the potential issues (experts from the EORTC QLG, collaborating centres, EORTC Breast Group, as well as experts from the International Male BC Consortium Group).

You may qualify if:

• Male sex
• Evidence of invasive breast cancer (any type) and/or ductal carcinoma in situ (DCIS) (current or anamnestic).
• Must be able and willing to complete the questionnaires.
• Must be able to understand and speak the language in which the patient will complete the questionnaire.

You may not qualify if:

• \. Cognitive impairment

Sponsors & Collaborators

• Unidad de cancer: collaborator
• Sørlandet Hospital, Kristiansand (SSHF): collaborator
• Medizinische Universität Innsbruck: collaborator
• Sunnybrook Health Science Centre: collaborator
• East Kent Gynaecological Oncology Centre, Queen Elizabeth the Queen Mother Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Helios University Hospital Wuppertal: lead
• Mugla Sitki Kocman University School of Medicine: collaborator
• UNED Pamplona: collaborator
• Aarhus University and University of Southern Denmark: collaborator
• University of Roma La Sapienza: collaborator

Study Sites (1)

Helios University Clinic Wuppertal, University Witten/Herdecke

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vesna Bjelic-Radisic, Prof

  Helios University Clinic Wuppertal, University 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 14, 2022
• First Posted: March 6, 2026
• Study Start: November 1, 2019
• Primary Completion: March 20, 2023
• Study Completion: March 31, 2023
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)