- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04905082
HOPE-Genomics Intervention per il miglioramento della conoscenza della genomica da parte dei malati di cancro
Aiutare i pazienti oncologici Explore-Genomics (HOPE-Genomics) Web Tool Sperimentazione clinica randomizzata
This clinical trial studies the effectiveness of a web-based cancer education tool called Helping Oncology Patients Explore Genomics (HOPE-Genomics) in improving patient knowledge of personal genomic testing results and cancer and genomics in general. HOPE-Genomics is a web-based education tool that teaches cancer/leukemia patients, and patients who may be at high-risk for developing cancer, about genomic testing and provide patients with information about their own genomic test results. The HOPE-Genomics tool may improve patient's genomic knowledge and quality of patient-centered care. In addition, it may also improve education and care quality for future patients.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Test the efficacy of the HOPE-Genomics intervention in improving patient knowledge of genomics.
II. Test the efficacy of the HOPE-Genomics intervention in improving patient receipt of guideline-concordant care.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (USUAL CARE): Patients receive education pamphlet about whole-genome sequencing (WES) and have their genomics test results returned by their clinician in a typical manner.
ARM II (RETURN OF RESULTS ONLY): Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.
ARM III (RETURN OF RESULTS PLUS PRE-TEST EDUCATION): Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.
After completion of study intervention, patients are followed up at 2 weeks, 3 and 9 months after receiving genomic test results.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
-
Duarte, California, Stati Uniti, 91010
- City of Hope Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Are enrolled in City of Hope (COH) Institutional Review Board (IRB) 07047
- Have a diagnosis of lung, breast, colorectal, pancreatic, ovarian or prostate cancer
- Having somatic, germline or paired somatic/germline sequencing
- Are fluent in English
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Are >= 18 years old
Exclusion Criteria:
- Are unable to provide informed consent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Arm I (usual care)
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner. |
Ancillary studies Receive usual care
Altri nomi:
|
|
Sperimentale: Arm II (genomics test results, HOPE-Genomics)
Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available. |
Ancillary studies View HOPE-Genomics tool after genomic test results are available
Altri nomi:
View HOPE-Genomics before sequencing results are available
Altri nomi:
Receive genomics test results
Altri nomi:
|
|
Sperimentale: Arm III (HOPE-Genomics, genomics test results)
Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool. |
Ancillary studies View HOPE-Genomics tool after genomic test results are available
Altri nomi:
View HOPE-Genomics before sequencing results are available
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recall Rates of Personal Genomic Results
Lasso di tempo: Up to 3 months
|
Recall rate refers to the proportion of patients who accurately remembered whether they had undergone genetic testing, as reported in the 10-day follow-up survey. If a patient's response at the 10-day mark was unavailable, their answer from the 3-month survey was used as a substitute. This metric helps assess how well patients retained and understood information about their genetic testing experience shortly after receiving their results. |
Up to 3 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Operationalization of Contextual Guideline Concordant Care
Lasso di tempo: Up to 12-month period after results disclosure
|
In the primary analysis, we will assess the uptake of contextualized guideline-concordant care taking into account clinically relevant, patient specific circumstances. Will use clinical characteristics from the electronic health record (EHR) to assign each patient to clinical category for which there are discrete National Comprehensive Cancer Network (NCCN) recommendations. Using patient self-reported baseline/T1 and EHR data, following sequencing disclosure, we will create a summary genetically-guided care variable ranging from 0-100%. In the secondary analyses, will define guideline concordant as meeting >= 75% of recommended guidelines. |
Up to 12-month period after results disclosure
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Test-related Distress
Lasso di tempo: 10 days, 3 months, 9 months
|
The psychosocial impact of genetic testing and patient uncertainty were assessed at 10 days, 3 months and 9 months using both the adapted PAGIS Certainty Scale and the FACToR. The FACToR was a 12-item measure that included four subscales: privacy concerns, uncertainty, test-related distress, and positive experiences. The overall FACToR score is computed by summing all items after reverse scoring the positivity subscale, resulting in a total range of 0 to 48. Higher total scores indicate greater psychosocial impact, which is considered a worse outcome. The PAGIS Certainty Subscale consists of 6 items scored on a 1-6 scale, with a total range of 6-36. Higher scores reflect greater certainty and better psychological adaptation to genetic information, which is considered a positive outcome. |
10 days, 3 months, 9 months
|
|
Genetically-guided Care
Lasso di tempo: Up to 9 months
|
In exploratory analyses related to Aim 2 (i.e. receipt of contextual guideline-concordant care), will also operationalize the secondary outcome in an additional way: Categories of genetically-guided care: Will evaluate patients' receipt of 1) treatment recommended by provider based on sequencing (any/none), 2) patients' sharing of sequencing results with family members (any/none), and 3) patients' consultation with genetic counseling/ recommended specialist (any/none). |
Up to 9 months
|
|
HOPE-Genomics Tool Usage
Lasso di tempo: Up to 9 months
|
Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements). |
Up to 9 months
|
|
Change in Genomic Knowledge Score
Lasso di tempo: baseline, pre-test (approximately 2-3 days after baseline), 10 days and 3 months
|
Genomic knowledge was assessed using a modified 35-item instrument comprising three subscales: cancer genomics knowledge, understanding of the use of genetic testing results in cancer care, and germline sequencing knowledge. Overall knowledge scores were calculated for patients who completed more than half of the items in the full measure. Each score was expressed as the percentage of correct responses out of the total number of questions answered in that category, with scores ranging from 0 to 100. The change in pre/post scores was calculated by taking the differences in knowledge scores from baseline to pre-test, 10-days and 3 months survey. |
baseline, pre-test (approximately 2-3 days after baseline), 10 days and 3 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Stacy W Gray, City of Hope Medical Center
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema endocrino
- Neoplasie genitali, maschio
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie intestinali
- Malattie delle vie respiratorie
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Neoplasie intestinali
- Malattie del retto
- Malattie genitali, femmina
- Malattie polmonari
- Neoplasie delle ghiandole endocrine
- Malattie pancreatiche
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Malattie del colon
- Malattie ovariche
- Malattie annessiali
- Neoplasie genitali, femmina
- Disturbi gonadici
- Malattie della pelle
- Malattie del seno
- Malattie della pelle e del tessuto connettivo
- Neoplasie prostatiche
- Neoplasie polmonari
- Neoplasie colorettali
- Neoplasie ovariche
- Neoplasie mammarie
- Neoplasie pancreatiche
- Amministrazione dei servizi sanitari
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Tecniche investigative
- Qualità dell'assistenza sanitaria
- Indicatori di qualità, assistenza sanitaria
- Servizi sanitari
- Force di lavoro e servizi per le strutture sanitarie
- Servizi sanitari per bambini
- Servizi sanitari della comunità
- Servizi sanitari preventivi
- Fattori socioeconomici
- Caratteristiche della popolazione
- Fenomeni genetici
- Linee guida come argomento
- Assicurazione della qualità, assistenza sanitaria
- Background genetico
- Metodi
- Standard di cura
- Intervento precoce, educativo
- Stato educativo
- Pratica le linee guida come argomento
- Profilo genetico
Altri numeri di identificazione dello studio
- 20430
- P30CA033572 (Sovvenzione/contratto NIH degli Stati Uniti)
- 20430 (Altro identificatore: City of Hope Medical Center)
- NCI-2021-03114 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
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