Implementering af et randomiseret kontrolforsøg for at teste den udvidede webbaserede beslutningsstøtte
The overall goal of the randomized control trial (RCT) will be to evaluate the efficacy of modifications to a web-based tool for patient decision-making regarding return of genomic results that will more closely focus on rare cancers. Participants will be given access to a web-based decision aid (or a standard control) that guides participants in making decisions about what type of genomic results they would like to receive from testing performed in the PE-CGS study (NCT06340646).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Missouri
-
St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Eligibility Criteria:
-
Enrolled in the WU-PE-CGS study (IRB#202106129); that eligibility entails:
- Diagnosis of cholangiocarcinoma
- Diagnosis of multiple myeloma, must be African American
- Diagnosis of colorectal cancer, must be African American and age 65 or older at time of diagnosis
-
At least 18 years old.
-
Able to understand an IRB-approved informed consent document and agree to participation
-
Have access to a personal computer, tablet or mobile device
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention: Genetics Advisor Online Tool
The Intervention group will receive the expanded Genetics Advisor decision aid. |
Participants will be given the option to receive different types of results from genomic sequencing. The participants will be given access to a web-based decision aid that elicits participants' values and preferences for receiving results from cancer genomic sequencing to guide them making a decision about what types of results they would like to receive. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. |
|
Aktiv komparator: Control: Standard developed materials
The control group will receive a description of each type of genomic sequencing result they could receive using the standard informed consent process for the return-of-results protocol. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in self-efficacy about genomic test results
Tidsramme: Baseline, after viewing assigned materials (day 1), and 3-months after enrollment
|
7-item, Likert scale. This scale has 5 points ranging from strongly disagree to strongly agree. 1= Strongly disagree, 2= Disagree, 3= Neither Agree nor Disagree, 4= Agree, 5= Strongly Agree. All items are scored such that 'strongly agree' reflects a correct response and 'agree' reflects a less confident correct response in the correct direction. This will be scored by adding up the numbers for each of the 7 items regarding self-efficacy. The total score ranges from 7 to 35. A higher score for the participant represents higher participant self-efficacy. |
Baseline, after viewing assigned materials (day 1), and 3-months after enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in decisional conflict
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
17-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree. All items are scored such that 'strongly disagree' reflects an incorrect response and 'disagree' reflects a less confident incorrect response in the incorrect direction. This will be scored by adding up the numbers for each of the 17 items regarding decisional conflict. The total score ranges from 17 to 85. The higher score for the participant represents higher participant decisional conflict. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Change in knowledge of clinical genetic testing
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
12-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-12) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, 5) are reverse scored so that "strongly agree' reflected a correct response and 'somewhat agree' reflected a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 12 to 60. A higher score for the participant represents higher participant knowledge. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Change in expectations for potential benefits of cancer genomic sequencing
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
Participants will rate their expectation for 6 potential benefits of cancer genomic sequencing on a 4-point scale ranging from extremely unlikely to extremely likely. . 1= Extremely unlikely, 2= Unlikely, 3= Likely, 4= Extremely likely. This will be scored by adding up the numbers for each of the 6 items regarding participant expectations of benefit. The total score ranges from 6 to 24. A higher score for the participant represents higher levels of expectations. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Decisional conflict scores categorized by demographic factors
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
17-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree. All items are scored such that 'strongly disagree' reflects an incorrect response and 'disagree' reflects a less confident incorrect response in the incorrect direction. This will be scored by adding up the numbers for each of the 17 items regarding decisional conflict. The total score ranges from 17 to 85. The higher score for the participant represents higher participant decisional conflict. Demographic factors include age, race, SES, and geographic residence. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Knowledge scores categorized by demographic factors
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
12-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-12) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, 5) are reverse scored so that "strongly agree' reflected a correct response and 'somewhat agree' reflected a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 12 to 60. A higher score for the participant represents higher participant knowledge. Demographic factors include age, race, SES, and geographic residence. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Decisional conflict scores categorized by genomic literacy
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
Genomic literacy will be measured at baseline. 14 items. For 7 items participants will rate their familiarity with genetic terminology on a 7 point scale ranging from strongly disagree to strongly agree. 1= Strongly disagree, 7= Strongly agree. This portion ill be scored by adding up the numbers for each of these 7 items. The total score on this portion ranges from 7 to 49. An additional 7 questions ask participants to fill in a missing word in a statement about genetics. These 7 items are multiple-choice questions and are scored by adding up the number of correct answers. The score on this portion ranges from 0 to 7. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Knowledge scores categorized by genomic literacy
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
Genomic literacy will be measured at baseline. 14 items. For 7 items participants will rate their familiarity with genetic terminology on a 7 point scale ranging from strongly disagree to strongly agree. 1= Strongly disagree, 7= Strongly agree. This portion ill be scored by adding up the numbers for each of these 7 items. The total score on this portion ranges from 7 to 49. An additional 7 questions ask participants to fill in a missing word in a statement about genetics. These 7 items are multiple-choice questions and are scored by adding up the number of correct answers. The score on this portion ranges from 0 to 7. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Decisional conflict scores categorized by genomic sequencing testing attitudes
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
Genomic sequencing testing attitudes is measured at baseline. 6-items. This scale has 4 points ranging from 'strongly disagree' to 'strongly agree'. 1= Strongly disagree, 4=Strongly agree. This is scored by adding up the numbers for each of the 6 items. The score ranges from 6 to 24. A higher score indicates a higher participant level of trust in genomic research participation. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Knowledge scores categorized by genomic sequencing testing attitudes
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
Genomic sequencing testing attitudes is measured at baseline. 6-items. This scale has 4 points ranging from 'strongly disagree' to 'strongly agree'. 1= Strongly disagree, 4=Strongly agree. This is scored by adding up the numbers for each of the 6 items. The score ranges from 6 to 24. A higher score indicates a higher participant level of trust in genomic research participation. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Decisional conflict scores categorized by clinical characteristics
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
7-item, Likert scale. This scale has 5 points ranging from strongly disagree to strongly agree. 1= Strongly disagree, 2= Disagree, 3= Neither Agree nor Disagree, 4= Agree, 5= Strongly Agree. All items are scored such that 'strongly agree' reflects a correct response and 'agree' reflects a less confident correct response in the correct direction. This will be scored by adding up the numbers for each of the 7 items regarding self-efficacy. The total score ranges from 7 to 35. A higher score for the participant represents higher participant self-efficacy. Clinical characteristics include cancer type, stage at diagnosis, and primary treatment. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
|
Knowledge scores categorized by clinical characteristics
Tidsramme: After viewing assigned materials (day 1) and 3-months after enrollment
|
12-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-12) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, 5) are reverse scored so that "strongly agree' reflected a correct response and 'somewhat agree' reflected a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 12 to 60. A higher score for the participant represents higher participant knowledge. Clinical characteristics include cancer type, stage at diagnosis, and primary treatment. |
After viewing assigned materials (day 1) and 3-months after enrollment
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Erin Linnenbringer, Ph.D., MS, Washington University School of Medicine
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Hæmatologiske sygdomme
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Tyktarmssygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Karcinom
- Neoplasmer, Plasmacelle
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Hæmoragiske lidelser
- Hemiske og lymfatiske sygdomme
- Kolorektale neoplasmer
- Cholangiocarcinom
- Myelomatose
Andre undersøgelses-id-numre
- 202409214
- U2CCA252981 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Will share all data, software and know-how generated during the course of this work, without limitations except as prevented by prior agreement. This will include both the final datasets, as well as the data necessary to complete the aims. Will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Wherever applicable, data will be deposited to appropriate public repositories.
All participants whose genomic data are collected will be consented for broad data sharing, and their genomic data will be included in the study deposits. Data documentation and de-identified data will be deposited for sharing along with phenotypic data, which includes demographics and diagnosis, consistent with applicable laws and regulations.
IPD-delingstidsramme
The investigators agree to deposit data into database of Genotypes and Phenotypes (dbGaP) repository after data cleaning and quality control as soon as possible but no later than within three months, or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier. When data are released from dbGaP, the data will be made available to the Genomic Data Commons (GDC).
IPD-delingsadgangskriterier
The investigators agree that they will identify where the data will be available (dbGaP and GDC) and how to access the data in any publications and presentations that they author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations. As they will be using the database of Genotypes and Phenotypes (dbGaP), which is an NIH-funded repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .