Clinical trial · Interventional
Co'Moon for Supporting Breast Cancer Patients on Adjuvant Endocrine Therapy
Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy
NCT05085678CI-TRIAL-00065053completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven.
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 |
| Quality of Life | — | UNRESOLVED | — |
| Self Efficacy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Co'moon (online website to support women with AET) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Standard of care: * a short overview of the physician on adjuvant endocrine therapy * a brochure on adjuvant endocrine therapy * a voluntary group session on adjuvant endocrine therapy and a monthly questionnaire on the patient reported outcomes
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Standard care with the access of to the online tool Co'moon and a monthly questionnaire on patient reported outcomes. The outcome of the questionnaires are summarized for the physician to discuss during the follow-up consultation.
- interventionNames
- Device: Co'moon (online website to support women with AET)
Primary outcomes (5)
- measure
- Change in quality of Life - FACT-ES - B5 - H18
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria patients: * Women * Older than 18 years * Speaking, understanding and writing Dutch fluently * Mentally competent * Recently underwent a operation for breast cancer (invasive or in situ) * Takes AET for maximum two months * Consultation planned within 4-5 month * Home access of a computer with internet connection Exclusion Criteria patients: * Different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (CDK) 4/6-inhibitors) * Metastatic disease Inclusion Criteria health care professionals: * Contact with patient(s) included in the trial Exclusion Criteria health care professionals: * Included in panels * Member of the research team
References
Publications (0)
Data not yet available
No reference posted for this study.