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Shared Decision Making on Immunotherapy in Oncology (PEF-Immun)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240717
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Innovationsfonds des Gemeinsamen Bundesausschusses
Information provided by (Responsible Party):
Christiane Bieber, Heidelberg University

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).


Condition or disease Intervention/treatment Phase
Patient Decision Aid Treatment As Usual Behavioral: Patient Decision Aid Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of metastatic melanoma (C43) stage 4 (UICC IV)
  • 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

Information from the National Library of Medicine

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


Locations
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Germany
University Hospital Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69115
Carl Gustav Carus University Hospital Dresden
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
University Hospital Heidelberg
Innovationsfonds des Gemeinsamen Bundesausschusses
Investigators
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Principal Investigator: Christiane Bieber, Prof. Dr. Heidelberg University
Publications:
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Responsible Party: Christiane Bieber, Prof. Dr. med., Heidelberg University
ClinicalTrials.gov Identifier: NCT04240717    
Other Study ID Numbers: 01VSF18047
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christiane Bieber, Heidelberg University:
Shared Decision Making
Patient Empowerment
Immunotherapy
Melanoma
Patient Decision Aid