Shared Decision Making on Immunotherapy in Oncology

NCT04240717 | Completed

• 1 other identifier: 01VSF18047
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

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).

Conditions

Patient Decision Aid; Treatment As Usual

Keywords

Shared Decision Making; Patient Empowerment; Immunotherapy; Melanoma; Patient Decision Aid

Outcome Measures

Primary Outcomes (1)

• Knowledge about different treatment options

  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.

  T1 = after intervention (PtDA/TAU); duration of assessment: 10 minutes

Secondary Outcomes (6)

• Decision satisfaction

  T1 = after intervention (PtDA/TAU); duration of assessment: 2 minutes

• Decision satisfaction (follow-up)

  T2 = approx. 3 months after intervention (PtDA/TAU), before and after being informed about potential tumor progress; duration of assessment: 2 minutes

• Patient involvement in the decision making process

  during medical consultation; duration of assessment: approx. 30 minutes

• Choice of treatment option

  T1 = after the intervention (PtDA/TAU); duration of assessment: 1 minute

• Quality of physician-patient interaction

  T1 = after the intervention (PtDA/TAU); duration of assessment: 2 minutes

Study Arms (2)

Patient Decision Aid

EXPERIMENTAL

Patients review an interactive, web-based Patient Decision Aid regarding their treatment options. Afterwards they receive medical consultation.

Behavioral: Patient Decision Aid

Treatment As Usual

NO INTERVENTION

Patients receive medical consultation.

Interventions

Patient Decision Aid BEHAVIORAL

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).

Also known as: Decision Aid

Patient Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of metastatic melanoma (C43), stage 3 and 4
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Innovationsfonds des Gemeinsamen Bundesausschusses, Germany: collaborator

Study Sites (2)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Carl Gustav Carus University Hospital Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (5)

• Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.

  PMID: 31562797 BACKGROUND

• Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.

  PMID: 28402085 BACKGROUND

• Volk RJ, Llewellyn-Thomas H, Stacey D, Elwyn G. Ten years of the International Patient Decision Aid Standards Collaboration: evolution of the core dimensions for assessing the quality of patient decision aids. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S1. doi: 10.1186/1472-6947-13-S2-S1. Epub 2013 Nov 29.

  PMID: 24624947 BACKGROUND

• Schadendorf D, van Akkooi ACJ, Berking C, Griewank KG, Gutzmer R, Hauschild A, Stang A, Roesch A, Ugurel S. Melanoma. Lancet. 2018 Sep 15;392(10151):971-984. doi: 10.1016/S0140-6736(18)31559-9.

  PMID: 30238891 BACKGROUND

• Grabbe P, Gschwendtner KM, Maatouk I, Strobel SB, Salzmann M, Bossert J, Eich W, Wild B, Meier F, Hassel JC, Bieber C. Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial. Trials. 2021 Apr 20;22(1):294. doi: 10.1186/s13063-021-05234-4.

  PMID: 33879219 DERIVED

MeSH Terms

Conditions

Patient Participation; Melanoma

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Christiane Bieber, Prof. Dr.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Participants are assigned to the interventional group (decision aid) or the control group (treatment-as-usual).

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 27, 2020
• Study Start: February 7, 2020
• Primary Completion: June 24, 2022
• Study Completion: October 8, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)