Remote Screening and Navigation to Increase Trial Enrollment, INVITE Trial (INVITE)
INVITE: Remote ScreenIng & NaVigation to Increase Trial Enrollment
This clinical trial studies the feasibility, acceptability, appropriateness, and effectiveness of a remote screening and navigation program in increasing clinical trial enrollment among patients with prostate and bladder cancer receiving cancer care in the community setting. Genitourinary (GU) cancers, including prostate and bladder cancer, are among the most common affecting patients in the United States. In spite of recent advances, there are still only a few broad categories of treatments effective in both prostate and bladder cancer, and investigating new therapies in clinical trials is essential. In Washington State, the majority of patients with prostate and bladder cancer are treated at local community oncology sites. Patients are referred to Fred Hutch (FH) GU oncologists for clinical trials, but often this referral occurs once a patient has exhausted all standard of care options for treatment. This remote screening and navigation study involves approaching patients at community oncology and urology clinics in the Washington State area and pre-screening them for eligibility in open clinical trials at FH. Interested eligible patients will then be referred to our patient navigation program to be seen by a GU medical oncologist at Fred Hutch Cancer Center. This program may help increase access to clinical trials for patients with prostate and bladder cancer, as well as strengthen collaboration between community oncology providers and GU oncology specialists at FH.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OUTLINE:
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center. Patients NOT eligible for a clinical trial are assigned to Group I. Patients who are immediately eligible for a clinical trial are assigned to Group II. Patients who are eligible for a clinical trial in the future upon disease progression or change in status are assigned to Group III.
GROUP I: Patients are notified and receive no further contact.
GROUP II: Patients who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are NOT interested receive no further contact. These patients may have the option for future pre-screening.
GROUP III: Patients who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are interested in pursuing the clinical trial(s) upon eligibility, but do not wish to proceed to a GU appointment have the option to reach out at time of eligibility for re-screening and appointment. Patients who are NOT interested in the clinical trial(s) they are eligible for and/or not interested in participation receive no further contact. These patients may have the option for future pre-screening.
After completion of study, patients are followed for 12 months.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hiba M. Khan, MD
- Numéro de téléphone: 206-606-2524
- E-mail: hibakhan@uw.edu
Lieux d'étude
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Washington
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Seattle, Washington, États-Unis, 98109
- Fred Hutch/University of Washington Cancer Consortium
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Contact:
- Hiba M. Khan, MD
- Numéro de téléphone: 206-606-2524
- E-mail: hibakhan@uw.edu
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Chercheur principal:
- Hiba M. Khan, MD
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Age ≥ 18
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Ability to understand English or Spanish
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Records must be available to review on Epic CareEverywhere
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Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants
- For participants utilizing LAR, participant must assent or otherwise be capable of completing patient-reported surveys
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Receiving care for prostate or bladder cancer at participating community sites
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
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Not enrolled in hospice
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group I (pre-screening)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients NOT eligible for a clinical trial are notified and receive no further contact. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
Autres noms:
|
|
Expérimental: Group II (pre-screening, GU appointment)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients who are immediately eligible for a clinical trial who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are immediately eligible for a clinical trial who are NOT interested receive no further contact. These patients may have the option for future pre-screening. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
Autres noms:
Attend appointment with GU medical oncologist
Autres noms:
|
|
Expérimental: Group III (pre-screening, GU appointment, re-screening)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are interested in pursuing the clinical trial(s) upon eligibility, but do not wish to proceed to a GU appointment have the option to reach out at time of eligibility for re-screening and appointment. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are NOT interested in the clinical trial(s) they are eligible for and/or not interested in participation receive no further contact. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
Autres noms:
Attend appointment with GU medical oncologist
Autres noms:
Undergo re-screening
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of patients who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
Délai: After pre-screening for clinical trials is complete (Up to 9 months)
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After pre-screening for clinical trials is complete (Up to 9 months)
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|
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Percentage of community providers who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
Délai: After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
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Percentage of patients who "agree" or "completely agree" in the Acceptability of Intervention Measure (Acceptability)
Délai: After pre-screening for clinical trials is complete (Up to 9 months)
|
After pre-screening for clinical trials is complete (Up to 9 months)
|
|
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Percentage of community providers who "agree" or "completely agree" in the Acceptability of Intervention Measure (Acceptability)
Délai: After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
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Percentage of patients who "agree" or "completely agree" in the Intervention Appropriateness Measure (Appropriateness)
Délai: After pre-screening for clinical trials is complete (Up to 9 months)
|
After pre-screening for clinical trials is complete (Up to 9 months)
|
|
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Percentage of community providers who "agree" or "completely agree" in the Intervention Appropriateness Measure (Appropriateness)
Délai: After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
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Percentage of remotely screened patients that are identified as eligible for a prostate or bladder cancer clinical trial at Fred Hutch (FH) and enroll in that clinical trial
Délai: Up to 9 months
|
Analysis of these percentages will be taken into context with the reported barriers that our patient population describes. Will provide rationale for a larger clinical trial, in which barriers can be directly addressed if possible, to assess improvement in clinical trial interest/participation among patients receiving care in the community. |
Up to 9 months
|
|
Percentage of remotely screened patients that are identified as eligible or potentially eligible for a prostate or bladder cancer clinical trial at FH, and express interest in participating
Délai: Up to 9 months
|
Analysis of these percentages will be taken into context with the reported barriers that our patient population describes. Will provide rationale for a larger clinical trial, in which barriers can be directly addressed if possible, to assess improvement in clinical trial interest/participation among patients receiving care in the community. |
Up to 9 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perceived barriers to participation in clinical trials
Délai: Baseline up to 9 months
|
Free-text survey data from patients and qualitative interview data from referring providers will be analyzed using Braun & Clarke's inductive thematic analysis framework. |
Baseline up to 9 months
|
|
Distribution of participants by race and ethnicity among remotely pre-screened patients who enroll or indicate intent to enroll in a clinical trial
Délai: Up to 9 months
|
Free-text survey data from patients and qualitative interview data from referring providers will be analyzed using Braun & Clarke's inductive thematic analysis framework. |
Up to 9 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hiba M. Khan, MD, Fred Hutch/University of Washington Cancer Consortium
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Tumeurs génitales, homme
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Tumeurs urologiques
- Maladies de la vessie urinaire
- Tumeurs prostatiques
- Tumeurs de la vessie urinaire
- Administration des services de santé
- Gestion des soins aux patients
- Soins de santé complets
- Soins centrés sur le patient
- Soins de santé primaires
- Navigation des patients
Autres numéros d'identification d'étude
- RG1126822
- P30CA015704 (Subvention/contrat des NIH des États-Unis)
- NCI-2026-07173 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- STUDY00025270 (Autre identifiant: Fred Hutch/University of Washington Cancer Consortium)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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