Shared Decision Making on Immunotherapy in Oncology

Treatment As Usual Clinical Trial

— PEF-Immun  

Official title:

Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04240717
• Other study ID #: 01VSF18047
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: October 8, 2022

Study information

• Verified date: November 2022
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 8, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Decision Aid
• Treatment As Usual

Intervention

Behavioral:
• Patient Decision Aid
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).

Locations

Country	Name	City	State
Germany	Carl Gustav Carus University Hospital Dresden	Dresden	Saxony
Germany	University Hospital Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Innovationsfonds des Gemeinsamen Bundesausschusses, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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, Márquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schöffski P, Carlino MS, Lebbé 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. — View Citation

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. Review. Erratum in: Lancet. 2019 Feb 23;393(10173):746. — View Citation

Stacey D, Légaré 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:CD001431. doi: 10.1002/14651858.CD001431.pub5. Review. — View Citation

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:S1. doi: 10.1186/1472-6947-13-S2-S1. Epub 2013 Nov 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Decision satisfaction (follow-up)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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