Shared Decision Making on Immunotherapy in Oncology (PEF-Immun)
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|ClinicalTrials.gov Identifier: NCT04240717|
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2020
Last Update Posted : March 24, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Patient Decision Aid Treatment As Usual||Behavioral: Patient Decision Aid||Not Applicable|
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. In total 90 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 (n = 45) will receive access to the interactive PtDA prior to a medical consultation. Patients of the control group (n = 45) 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are assigned to the interventional group (decision aid) or the control group (treatment-as-usual).|
|Masking:||None (Open Label)|
|Official Title:||Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial|
|Actual Study Start Date :||February 7, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Patient Decision Aid
Patients review an interactive, web-based Patient Decision Aid regarding their treatment options. Afterwards they receive medical consultation.
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).
Other Name: Decision Aid
No Intervention: Treatment As Usual
Patients receive medical consultation.
- Knowledge about different treatment options [ Time Frame: T1 = after intervention (PtDA/TAU); duration of assessment: 10 minutes ]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.
- Decision satisfaction [ Time Frame: T1 = after intervention (PtDA/TAU); duration of assessment: 2 minutes ]Decision satisfaction is assessed by the Satisfaction with Decision Scale (SwD; min. value: 6, max. value: 30; higher scores indicate higher satisfaction with decision)
- Decision satisfaction (follow-up) [ Time Frame: T2 = approx. 3 months after intervention (PtDA/TAU), before and after being informed about potential tumor progress; duration of assessment: 2 minutes ]Decision satisfaction is assessed with the same scale used at T1 (see Outcome 2 for a detailed description)
- Patient involvement in the decision making process [ Time Frame: during medical consultation; duration of assessment: approx. 30 minutes ]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)
- Choice of treatment option [ Time Frame: T1 = after the intervention (PtDA/TAU); duration of assessment: 1 minute ]Choice of treatment option is assessed by a self-developed item
- Quality of physician-patient interaction [ Time Frame: T1 = after the intervention (PtDA/TAU); duration of assessment: 2 minutes ]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)
- Knowledge about different treatment options (follow-up) [ Time Frame: T2: approx. 3 months after intervention (PtDA/TAU), before being informed about potential tumor progress; duration of assessment: 10 minutes ]Knowledge is assessed with the same multiple choice test used at T1 (see Outcome 1 for a detailed description).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240717
|University Hospital Heidelberg|
|Heidelberg, Baden-Württemberg, Germany, 69115|
|Carl Gustav Carus University Hospital Dresden|
|Dresden, Saxony, Germany, 01307|
|Principal Investigator:||Christiane Bieber, Prof. Dr.||Heidelberg University|