NCT04240717 (PEF-Immun) is a NA clinical trial of Patient Decision Aid in Patient Decision Aid, sponsored by University Hospital Heidelberg.

Who is sponsoring NCT04240717?

NCT04240717 is sponsored by University Hospital Heidelberg.

What drugs are being tested in NCT04240717?

Interventions in NCT04240717: Patient Decision Aid.

What condition does NCT04240717 study?

NCT04240717 studies Patient Decision Aid, Treatment As Usual.

Is NCT04240717 still recruiting?

NCT04240717 is currently completed. Last updated 7 November 2022.

Last reviewed 2022-11-07 · How we verify

NCT04240717: PEF-Immun

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Shared Decision Making on Immunotherapy in Oncology

Completed NA Last updated 7 November 2022

What this trial tests

NA trial testing Patient Decision Aid in Patient Decision Aid in 126 participants. Completed in 8 October 2022.

Timeline

7 February 2020

Primary endpoint
24 June 2022

8 October 2022

Quick facts

Lead sponsor	University Hospital Heidelberg
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	7 February 2020
Primary completion	24 June 2022
Estimated completion	8 October 2022
Sites	2 locations across Germany

Drugs / interventions tested

Patient Decision Aid

Conditions studied

Patient Decision Aid — all drugs for Patient Decision Aid →
Treatment As Usual — all drugs for Treatment As Usual →

Sponsor

University Hospital Heidelberg

Who can join

18 and older, any sex, with Patient Decision Aid or Treatment As Usual. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Decision aids for people facing health treatment or screening decisions.
Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6
Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial.
Grabbe P, Gschwendtner KM, Maatouk I, Strobel SB, et al · · 2021 · cited 3× · PMID 33879219 · DOI 10.1186/s13063-021-05234-4

Verify or expand the search:

Other trials of Patient Decision Aid

Trials testing the same drug.

NCT07146152 — Empowering Women - Shared Decision Making in Managing Cervical Precancer · NA · not yet recruiting
NCT04375566 — Progressive Web App About Individualized Patient Decision Aid for NSCLC Stage I-II · unknown
NCT04357288 — Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation · NA · completed
NCT03568552 — Patient Decision Aid for Opioid Use Disorder · NA · completed
NCT03631758 — Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions · NA · completed

Other University Hospital Heidelberg trials

Trials by the same sponsor.

NCT07388147 — Exercise Therapy for Multiple Myeloma Patients · NA · not yet recruiting
NCT07348874 — Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany · not yet recruiting
NCT07181928 — Is Mentalization-based Therapy More Effective Than Treatment-as-usual for Adolescents With Dissocial Disorders? · NA · not yet recruiting
NCT06954623 — Partial Breast Re-irradiation for Breast Cancer · NA · recruiting
NCT06913010 — DV 100 as a Framework for the Hospital Incident Command System · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04240717 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital Heidelberg
Last refreshed: 7 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04240717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing