Clinical trial · Interventional
The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction
The Impact of a Web-based Decision Aid for Women Considering Breast Reconstruction: a Randomized Controlled Trial
- 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 study evaluates the impact of an online patient decision aid on the process of decision making regarding breast reconstruction and the decision quality in women with breast cancer undergoing mastectomy and considering immediate breast reconstruction. Half of participants will receive care as usual and access to the online decision aid, while the other half will receive care as usual including a standard information leaflet.
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 |
|---|---|---|---|
| online patient decision aid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intervention group
- description
- Care as usual and an online patient decision aid
- interventionNames
- Other: online patient decision aid
- type
- NO_INTERVENTION
- label
- control group
- description
- Care as usual with a standard information leaflet
Primary outcomes (1)
- measure
- decisional conflict
- timeFrame
- 1 week after consultation with a plastic surgeon (T1)
- description
- decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * female (≥18 years); * diagnosed with breast cancer or carcinoma in situ; * will be treated with mastectomy and is eligible for immediate breast reconstruction; * is referred to a plastic surgeon (consultation takes place ≥3 working days after study invitation); * has internet access and sufficient computer skills; * is able to read and speak the Dutch language. Exclusion Criteria: None
References
Publications (2)
- DERIVEDTer Stege JA, Woerdeman LAE, Kieffer JM, Sherman KA, Agelink van Rentergem JA, van Duijnhoven FH, van Huizum MA, Gerritsma MA, Kuenen M, Corten EML, Kimmings NAN, Ruhe QPQ, Krabbe-Timmerman IS, Van't Riet M, Hahn DEE, Witkamp AJ, Oldenburg HSA, Bleiker EMA. Efficacy of a Decision Aid in Breast Cancer Patients Considering Immediate Reconstruction: Results of a Randomized Controlled Trial. Plast Reconstr Surg. 2024 Oct 1;154(4):706-722. doi: 10.1097/PRS.0000000000011100. Epub 2023 Oct 9. PMID 37815283
- DERIVEDTer Stege JA, Woerdeman LAE, Hahn DEE, van Huizum MA, van Duijnhoven FH, Kieffer JM, Retel VP, Sherman KA, Witkamp AJ, Oldenburg HSA, Bleiker EMA. The impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction: study protocol of a multicenter randomized controlled trial. BMC Med Inform Decis Mak. 2019 Aug 19;19(1):165. doi: 10.1186/s12911-019-0873-1. PMID 31426772