Clinical trial · Interventional
Shared Decision Making on Immunotherapy in Oncology
Shared Decision Making on Immunotherapy in Oncology - Prospective, 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)
Patients with advanced melanoma are confronted with a serious treatment decision. The current guideline recommends considering the option of immunotherapy with checkpoint inhibitors. The substances approved for this purpose differ greatly in their efficacy and the risk for adverse events. Besides, in about half of the patients with advanced melanoma a BRAF V600 Mutation is found. In these patients, in addition to immunotherapy, treatment with BRAF/MEK inhibitors must be considered. Research on shared decision making suggests that patients achieve greater satisfaction with the decision if they are actively being involved in the decision-making process. To enable them to do so, an interactive, web-based patient decision aid (PtDA) informing about the treatment options for advanced melanoma will be developed and evaluated in a bicentric, prospective randomized controlled clinical trial. The use of PtDA is expected to lead to a higher level of information about the benefits and risks of the various treatment options (primary hypothesis).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patient Decision Aid | — | UNRESOLVED | — |
| Treatment As Usual | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Decision Aid | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient Decision Aid
- description
- Patients review an interactive, web-based Patient Decision Aid regarding their treatment options. Afterwards they receive medical consultation.
- interventionNames
- Behavioral: Patient Decision Aid
- type
- NO_INTERVENTION
- label
- Treatment As Usual
- description
- Patients receive medical consultation.
Primary outcomes (1)
- measure
- Knowledge about different treatment options
- timeFrame
- T1 = after intervention (PtDA/TAU); duration of assessment: 10 minutes
- description
- Knowledge is assessed by a self-developed multiple choice test assessing knowledge about course, benefits, risks, and mechanisms of actions of different treatment options. Higher scores indicate higher knowledge about treatment options.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of metastatic melanoma (C43), stage 3 and 4 * first-line therapy * tumor or metastases are not resectable * sufficient knowledge of the German language to use the PtDA * informed written consent to participate in the study Exclusion Criteria: * limited legal capacity or impairments in this respect * cognitive or physical impairments, which severely complicate the use of the Patient Decision Aid (e.g. impaired vision) * severe psychiatric or mental illness
References
Publications (5)
- BACKGROUNDLarkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28. PMID 31562797
- BACKGROUNDStacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5. PMID 28402085
- BACKGROUNDVolk RJ, Llewellyn-Thomas H, Stacey D, Elwyn G. Ten years of the International Patient Decision Aid Standards Collaboration: evolution of the core dimensions for assessing the quality of patient decision aids. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S1. doi: 10.1186/1472-6947-13-S2-S1. Epub 2013 Nov 29. PMID 24624947
- BACKGROUNDSchadendorf D, van Akkooi ACJ, Berking C, Griewank KG, Gutzmer R, Hauschild A, Stang A, Roesch A, Ugurel S. Melanoma. Lancet. 2018 Sep 15;392(10151):971-984. doi: 10.1016/S0140-6736(18)31559-9. PMID 30238891
- DERIVEDGrabbe P, Gschwendtner KM, Maatouk I, Strobel SB, Salzmann M, Bossert J, Eich W, Wild B, Meier F, Hassel JC, Bieber C. Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial. Trials. 2021 Apr 20;22(1):294. doi: 10.1186/s13063-021-05234-4. PMID 33879219