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| Name | Class |
|---|---|
| Innovationsfonds des Gemeinsamen Bundesausschusses, Germany | UNKNOWN |
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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).
Immunotherapies are regarded as a new, promising treatment option for patients with advanced melanoma. However, immunotherapies can cause massive up to life-threatening side effects. The risks and benefits vary considerably between the possible therapy options. 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. This treatment option usually produces a rapid response. In most cases, however, melanomas develop resistance after about 12 months.
Therefore, patients with advanced melanoma and their treating physicians are confronted with a very complex and preference-sensitive decision situation. Support in the form of a Patient Decision Aid (PtDA) can be helpful to support this complex decision-making process.
In the first project phase, an interactive web-based PtDA on treatment options for advanced melanomas will be developed. In the second phase of the project, the PtDA will be evaluated in a prospective randomized controlled clinical trial. Patients with a diagnosis of advanced melanoma will be recruited at the National Center for Tumor Diseases (NCT) Heidelberg and at the University Cancer Center (UCC) Dresden.
Patients of the intervention group will receive access to the interactive PtDA prior to a medical consultation. Patients of the control group will receive the medical consultation only (treatment-as-usual). Group differences between the intervention group and the control group are analysed at T1 (immediately after the medical consultation) and T2 (three months after the medical consultation). The following variables are measured: informedness of the decision (primary outcome), decision satisfaction, and involvement of the patients in the decision process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Decision Aid | Experimental | Patients review an interactive, web-based Patient Decision Aid regarding their treatment options. Afterwards they receive medical consultation. |
|
| Treatment As Usual | No Intervention | Patients receive medical consultation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Decision Aid | Behavioral | The Patient Decision Aid is an interactive, web-based tool that provides information on advanced melanoma and its treatment options with a strong focus on immunotherapies (i.e. response to therapy, risk of side effects). |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge about different treatment options | 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. | T1 = after intervention (PtDA/TAU); duration of assessment: 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Decision satisfaction | Decision satisfaction is assessed by the Satisfaction with Decision Scale (SwD; min. value: 6, max. value: 30; higher scores indicate higher satisfaction with decision) | T1 = after intervention (PtDA/TAU); duration of assessment: 2 minutes |
| Decision satisfaction (follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Bieber, Prof. Dr. | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Heidelberg | Heidelberg | Baden-Wurttemberg | 69115 | Germany | ||
| Carl Gustav Carus University Hospital Dresden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31562797 | Background | Larkin 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. | |
| 28402085 |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Participants are assigned to the interventional group (decision aid) or the control group (treatment-as-usual).
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|
Decision satisfaction is assessed with the same scale used at T1 (see Outcome 2 for a detailed description) |
| T2 = approx. 3 months after intervention (PtDA/TAU), before and after being informed about potential tumor progress; duration of assessment: 2 minutes |
| Patient involvement in the decision making process | Patient involvement in the decision making process is assessed by the Observer OPTION 5 (min. value: 0, max. value: 20, higher scores indicate higher patient involvement in the decision making process) | during medical consultation; duration of assessment: approx. 30 minutes |
| Choice of treatment option | Choice of treatment option is assessed by a self-developed item | T1 = after the intervention (PtDA/TAU); duration of assessment: 1 minute |
| Quality of physician-patient interaction | Quality of physician-patient interaction is assessed by the Questionnaire on the Quality of Physician-Patient Interaction (QQPPI, min. value: 14, max. value: 70, higher values indicate higher quality of physician-patient interaction) | T1 = after the intervention (PtDA/TAU); duration of assessment: 2 minutes |
| Knowledge about different treatment options (follow-up) | Knowledge is assessed with the same multiple choice test used at T1 (see Outcome 1 for a detailed description). | T2: approx. 3 months after intervention (PtDA/TAU), before being informed about potential tumor progress; duration of assessment: 10 minutes |
| Dresden |
| Saxony |
| 01307 |
| Germany |
| Background |
| Stacey 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. |
| 24624947 | Background | Volk 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. |
| 30238891 | Background | Schadendorf 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. |
| 33879219 | Derived | Grabbe 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. |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |