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Completed

NCT Number: NCT04240717

Shared Decision Making on Immunotherapy in Oncology

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

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About this study

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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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).

Other names: Decision Aid

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Innovationsfonds des Gemeinsamen Bundesausschusses, Germany

Registry information

Official study title

Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial

Acronym: PEF-Immun

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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