Clinical trial NCT04240717: Shared Decision Making on Immunotherapy in Oncology
Official title: Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Decision Aid
Treatment As Usual
Keywords: Shared Decision Making
Patient Empowerment
Immunotherapy
Melanoma
Patient Decision Aid
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Innovationsfonds des Gemeinsamen Bundesausschusses, Germany
First posted: 2020-01-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to the interventional group (decision aid) or the control group (treatment-as-usual).
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge about different treatment options
timeFrame: T1 = after intervention (PtDA/TAU); duration of assessment: 10 minutes
Secondary outcomes:
measure: Decision satisfaction
timeFrame: T1 = after intervention (PtDA/TAU); duration of assessment: 2 minutes
measure: Decision satisfaction (follow-up)
timeFrame: T2 = approx. 3 months after intervention (PtDA/TAU), before and after being informed about potential tumor progress; duration of assessment: 2 minutes
measure: Patient involvement in the decision making process
timeFrame: during medical consultation; duration of assessment: approx. 30 minutes
measure: Choice of treatment option
timeFrame: T1 = after the intervention (PtDA/TAU); duration of assessment: 1 minute
measure: Quality of physician-patient interaction
timeFrame: T1 = after the intervention (PtDA/TAU); duration of assessment: 2 minutes
measure: Knowledge about different treatment options (follow-up)
timeFrame: T2: approx. 3 months after intervention (PtDA/TAU), before being informed about potential tumor progress; duration of assessment: 10 minutes
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
city: Dresden
country: Germany
facility: Carl Gustav Carus University Hospital Dresden
state: Saxony
Study officials:
affiliation: Heidelberg University
name: Christiane Bieber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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(Suppl 2):S1. doi: 10.1186/1472-6947-13-S2-S1. Epub 2013 Nov 29.
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.
citation: 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.