Shared Decision Making on Immunotherapy in Oncology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2022-10-08

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Patient Decision Aid Treatment As Usual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to the interventional group (decision aid) or the control group (treatment-as-usual).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient Decision Aid

Patients review an interactive, web-based Patient Decision Aid regarding their treatment options. Afterwards they receive medical consultation.

Group Type EXPERIMENTAL

Patient Decision Aid

Intervention Type 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).

Treatment As Usual

Patients receive medical consultation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Decision Aid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No