Clinical trial · Interventional
Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment.
Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.
NCT03375801CI-TRIAL-00046224BRASAcompletedN/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)
This is a pre-and post intervention study on the effect and implementation of an personalized decision aid for woman with breast cancer who face a decision on their radiation treatment.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Aid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control group/pre intervention
- description
- the first 164 patients will receive care as usual and will make the decision together with their clinician without support of the decision aid. They will be asked to fill out the questionnaires.
- type
- EXPERIMENTAL
- label
- intervention arm
- description
- another 164 patients will receive the decision aid as support for the decision making process with their clinician.
- interventionNames
- Other: Decision Aid
Primary outcomes (1)
- measure
- Decisional conflict
- timeFrame
- 90 days after the decision on their radiation treatment has been made
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * Female * Doubtful indication of: * Whole breast irradiation after lumpectomy for DCIS * Whole breast irradiation after lumpectomy for low risk invasive BC (TOP-1 study) * Boost dose in case of Breast Conserving Therapy * Thoracic wall irradiation post mastectomy Exclusion Criteria: * Metastasis * Inability to speak and read Dutch. Inability to use internet access, either in the home or at a hospital facility.
References
Publications (1)
- DERIVEDRaphael DB, Russell NS, Immink JM, Westhoff PG, Stenfert Kroese MC, Stam MR, van Maurik LM, van den Bongard HJGD, Maduro JH, Sattler MGA, van der Weijden T, Boersma LJ. Risk communication in a patient decision aid for radiotherapy in breast cancer: How to deal with uncertainty? Breast. 2020 Jun;51:105-113. doi: 10.1016/j.breast.2020.04.001. Epub 2020 Apr 6. PMID 32298961