Patient Decision AidPEF-ImmunNCT04240717
Shared Decision Making on Immunotherapy in Oncology
A study testing Patient Decision Aid in people with Patient Decision Aid and Treatment As Usual, run by University Hospital Heidelberg at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Decision Aid, Treatment As Usual
- What is being tested?
- Patient Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesGermany
- Study dates
- 7 Feb 2020to 8 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Carl Gustav Carus University Hospital Dresden
Dresden, Saxony, 01307
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69115
About this study
Official title: Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial
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).
Read the 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. 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.
- Conditions
- Patient Decision Aid, Treatment As Usual
- Being tested
- Patient Decision Aid
- Keywords
- Shared Decision Making, Patient Empowerment, Immunotherapy, Melanoma, Patient Decision Aid
- Medical subject headings
- Patient Participation, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Decision AidBehavioural
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Aid | Experimental | Patients review an interactive, web-based Patient Decision Aid regarding their treatment options. Afterwards they receive medical consultation. Receives: Behavioral: Patient Decision Aid |
| Treatment As Usual | No intervention | Patients receive medical consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1 = after intervention (PtDA/TAU); duration of assessment: 10 minutes
Secondary outcomes (6)
Decision satisfaction
Decision satisfaction is assessed by the Satisfaction with Decision Scale (SwD; min. value: 6, max. value: 30; higher scores indicate higher satisfaction with decision)
Measured: T1 = after intervention (PtDA/TAU); duration of assessment: 2 minutes
Decision satisfaction (follow-up)
Decision satisfaction is assessed with the same scale used at T1 (see Outcome 2 for a detailed description)
Measured: 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
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)
Measured: during medical consultation; duration of assessment: approx. 30 minutes
Choice of treatment option
Choice of treatment option is assessed by a self-developed item
Measured: T1 = after the intervention (PtDA/TAU); duration of assessment: 1 minute
Quality of physician-patient interaction
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)
Measured: T1 = after the intervention (PtDA/TAU); duration of assessment: 2 minutes
Knowledge about different treatment options (follow-up)
Knowledge is assessed with the same multiple choice test used at T1 (see Outcome 1 for a detailed description).
Measured: T2: approx. 3 months after intervention (PtDA/TAU), before being informed about potential tumor progress; duration of assessment: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start7 Feb 2020
- Primary completion24 Jun 2022
- Study completion8 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patient Decision AidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to the interventional group (decision aid) or the control group (treatment-as-usual).
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Innovationsfonds des Gemeinsamen Bundesausschusses, Germany
- Responsible party
- Principal investigator, Christiane Bieber, Heidelberg University
- Investigators
- Christiane Bieber, Prof. Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240717
- Sponsor's protocol ID
- 01VSF18047
- Acronym
- PEF-Immun
- Status last verified
- Nov 2022
- First submitted
- 23 Dec 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31562797Stacey 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.
PubMed 28402085Volk 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.
PubMed 24624947Schadendorf 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.
PubMed 30238891Grabbe 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.
PubMed 33879219
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04240717
- Acronym / sponsor ID
- PEF-Immun / 01VSF18047
- Conditions
- Patient Decision Aid, Treatment As Usual
- Keywords
- Shared Decision Making, Patient Empowerment, Immunotherapy, Melanoma, Patient Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Innovationsfonds des Gemeinsamen Bundesausschusses, Germany
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 8 Oct 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to the interventional group (decision aid) or the control group (treatment-as-usual).
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Aid | Experimental | Behavioral: Patient Decision AidPatients review an interactive, web-based Patient Decision Aid regarding their treatment options. Afterwards they receive medical consultation. |
| Treatment As Usual | No intervention | –Patients receive medical consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Decision AidAlso: Decision AidThe 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). | Behavioural | Patient Decision Aid |
Primary outcome
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.
6 secondary outcomes
Decision satisfaction
Time frame: T1 = after intervention (PtDA/TAU); duration of assessment: 2 minutes
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
Patient involvement in the decision making process
Time frame: during medical consultation; duration of assessment: approx. 30 minutes
Choice of treatment option
Time frame: T1 = after the intervention (PtDA/TAU); duration of assessment: 1 minute
Quality of physician-patient interaction
Time frame: T1 = after the intervention (PtDA/TAU); duration of assessment: 2 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 31562797Larkin 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.
- Background: PubMed 28402085Stacey 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.
- Background: PubMed 24624947Volk 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.
- Background: PubMed 30238891Schadendorf 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.
- Derived from this study: PubMed 33879219Grabbe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Bieber, Prof. Dr. principal investigator
Heidelberg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Decision Aid in people with Patient Decision Aid and Treatment As Usual, run by University Hospital Heidelberg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about different treatment options (time frame: T1 = after intervention (PtDA/TAU); duration of assessment: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240717, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.