Clinical trial · Interventional
Implementation of Shared Decision-Making in Cancer Care
Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial
NCT03393351CI-TRIAL-00052110PREPAREDcompletedN/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 study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shared decision-making program | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Shared decision-making program
- interventionNames
- Other: Shared decision-making program
- type
- ACTIVE_COMPARATOR
- label
- Usual care
- interventionNames
- Other: Usual Care
Primary outcomes (1)
- measure
- Change in uptake of shared decision-making from the patients' perspective
- timeFrame
- All clinics: baseline, 8 months, 16 months, 24 months
- description
- Action to employ shared decision-making as measured by the German version of the 9-item Shared Decision Making Questionnaire (SDM-Q-9)
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for participating patients: * diagnosed with neoplasms (ICD 10: C00-D49, excluding D10-D36) * admitted for inpatient or outpatient treatment at the participating clinics * age \> 18 years * German-speaking Exclusion Criteria for participating patients: * severe cognitive impairment Inclusion Criteria for participating health care professionals: * physician or nurse working at the participating clinics Exclusion Criteria for participating health care professionals: * none
References
Publications (3)
- BACKGROUNDScholl I, Hahlweg P, Lindig A, Bokemeyer C, Coym A, Hanken H, Muller V, Smeets R, Witzel I, Kriston L, Harter M. Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial. Implement Sci. 2018 Mar 27;13(1):51. doi: 10.1186/s13012-018-0740-y. PMID 29580249
- DERIVEDHahlweg P, Lindig A, Frerichs W, Zill J, Hanken H, Muller V, Peters MC, Scholl I. Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial. BMC Health Serv Res. 2023 Aug 8;23(1):840. doi: 10.1186/s12913-023-09778-w. PMID 37553560
- DERIVEDScholl I, Hahlweg P, Lindig A, Frerichs W, Zill J, Cords H, Bokemeyer C, Coym A, Schmalfeldt B, Smeets R, Vollkommer T, Witzel I, Harter M, Kriston L. Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial. Implement Sci. 2021 Dec 29;16(1):106. doi: 10.1186/s13012-021-01174-4. PMID 34965881