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Shared Decision Making on Immunotherapy in Oncology

NCT04240717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-11-07

No results posted yet for this study

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).

Conditions

  • Patient Decision Aid
  • Treatment As Usual

Interventions

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).

Sponsors & Collaborators

  • Innovationsfonds des Gemeinsamen Bundesausschusses, Germany

    collaborator UNKNOWN

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Christiane Bieber, Prof. Dr. · Heidelberg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2022-06-24
Completion
2022-10-08

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240717 on ClinicalTrials.gov