Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04240717
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2019-12-23
Brief Title:
Shared Decision Making on Immunotherapy in Oncology
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Shared Decision Making on Immunotherapy in Oncology - Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEF-Immun
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 BRAFMEK 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
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 BRAFMEK 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None