Clinical trial · Observational
EORTC Quality of Life Measurement in Males With Breast Cancer
Adaption of the EORTC Quality of Life Breast Cancer Module for Male Breast Cancer - Phase I
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| structured Interview | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Relevance
- timeFrame
- Single assessment at study enrollment (issues rated with recall period of the past 7 days or past 4 weeks, depending on item specification)
- description
- 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.
- measure
- Importance
- timeFrame
- Single assessment at study enrollment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male sex 2. Evidence of invasive breast cancer (any type) and/or ductal carcinoma in situ (DCIS) (current or anamnestic). 3. Must be able and willing to complete the questionnaires. 4. Must be able to understand and speak the language in which the patient will complete the questionnaire. Exclusion Criteria: 1\. Cognitive impairment
References
Publications (0)
Data not yet available