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Trial record 1 of 1 for:    05548621
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A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC) (SDM-RCC)

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ClinicalTrials.gov Identifier: NCT05548621
Recruitment Status : Recruiting
First Posted : September 21, 2022
Last Update Posted : November 29, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Cato Bresser, St. Antonius Hospital

Study Description
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Brief Summary:
The aim of this study is to evaluate the effect of two decision aids for renal cell carcinoma (RCC) on the decision-making process and the quality of the decision.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Renal Cell Carcinoma Metastatic Other: Decision aid

Detailed Description:

Background: Treatment options for patients diagnosed with RCC depend on the stage of the disease, histopathology and patient's preferences and values regarding outcomes. For local (non-metastatic) disease, gold standard for treatment is surgical resection of the tumour. Besides this, ablative therapies or active surveillance could also be an option. For metastatic disease, targeted therapy and/or immunotherapy can be offered and new treatment options are being tested in clinical trials. The number of available treatment options for patients with RCC is increasing, but the availability of these options differs per hospital and the transparency about treatment options is limited, resulting in practice variation between hospitals.

Decision aids help patients to make decisions regarding treatment, particularly when there is not one medically superior treatment option. In this tools treatment options are explained, including outcome information such as possible side effects and benefits of therapy. Decision aids have proven to lead to increased patient knowledge, less anxiety in patients, improved health outcomes such as physical en mental health, reductions in unwarranted variation in care and costs, greater alignment of care with patients' values.

For patients with RCC, two decision aids are in development right now: one decision aid focussed on local disease and one decision aid focussed on metastatic disease. Using these decision aids, patients are encouraged to make a well-informed decision together with the healthcare professional.

Objective: To assess how the decision aids for RCC influence the quality of the decision-making processes for RCC, defined as the extent to which elements of shared decision-making (SDM) are observed.

Design, setting and participants: This study includes patients clinically diagnosed with RCC, facing a decision which is addressed in the decision aids. Study design will be a prospective multicenter pre-test post-test study.

Outcome measurements and statistical analysis: The primary endpoint of this study is the mean change in OPTION-5 score between pre-test and post-test groups. Secondary outcome measures include perceived quality of the decision-making process, quality of the decision and implementation of the decision aids.

Study Design
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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Evaluate the Implementation of Shared Decision Making Strategy for Renal Cell Cancer (RCC)
Actual Study Start Date : November 24, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Pre-test
Patients with RCC receiving usual care (without use of the decision aids)
Post-test
Patients with RCC using the decision aids
 Other: Decision aid
Online interactive decision aid for RCC


Outcome Measures
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Primary Outcome Measures :
  1. OPTION-5 [ Time Frame: During consultation ]
    Observed patient involvement in decision-making


Secondary Outcome Measures :
  1. Decisional conflict scale [ Time Frame: Two weeks and nine weeks after consultation ]
    Validated scale to measure personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty and effective decision making.

  2. Preparation for decision-making [ Time Frame: Two weeks after consultation ]
    Validated scale that assesses the patient's perception of how useful a decision aid is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision.

  3. Control preference scale [ Time Frame: Two weeks after consultation ]
    Validated measure of patient's preferred and actual roles in treatment decisions

  4. SDM-Q-9 [ Time Frame: Health care professional: directly after consultatiion, patient: two weeks after consultation ]
    Validated questionnaire of perceived level of shared decision-making

  5. Knowledge check [ Time Frame: Two weeks after consultation ]
    Objective assessment of patient's understanding of information relevant for the decision at stake using ten questions which can be answered as true/false/I don't know.

  6. Implementation of the decision aids [ Time Frame: Nine weeks after consultation ]
    Qualitative information about experiences with implementation and use of the decision aids will be obtained through semi-structured interviews with patients and healthcare professionals.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients clinically diagnosed with RCC
Criteria

Inclusion Criteria:

  • Patients clinically diagnosed with RCC
  • Patients facing a decision which is addressed in the decision aids (T1 tumor or metastatic disease)
  • Written informed consent

Exclusion Criteria:

  • Patients who are not able to fill in a questionnaire or undergo an interview individually
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05548621


Contacts
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Contact: Cato Bresser 0631143301 c.bresser@antoniusziekenhuis.nl

Locations
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Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Contact: Cato Bresser    0631143301    c.bresser@antoniusziekenhuis.nl   
Sponsors and Collaborators
St. Antonius Hospital
Merck Sharp & Dohme LLC
More Information
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Responsible Party: Cato Bresser, Coordinating Investigator, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT05548621    
Other Study ID Numbers: WW 22.121/NWMO22.06.013
First Posted: September 21, 2022    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cato Bresser, St. Antonius Hospital:
decision aid
renal cell carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases