Feasibility Pilot of AYA-PARTNER (AYA-PARTNER)
Feasibility Pilot of the Adapted Adolescent and Young Adult Patient Advocacy, Real-Time Navigation, Equity and Reach (AYA-PARTNER) Intervention To Address Unmet Needs of AYAs Undergoing Active Cancer Treatment
This is a single-center, non-randomized feasibility pilot study of an adapted Adolescent and Young Adult Patient Advocacy, Real-Time Navigation, Equity and Reach (AYA-PARTNER) intervention for young adults ages 18-39 receiving systemic cancer treatment at the University of North Carolina at Chapel Hill (UNC) and UNC Rex and affiliated clinics.
The study will use information from the electronic health record to identify young adults who may have unmet needs during cancer treatment. Examples include emergency or urgent care visits, missed appointments, no activation of the patient portal (MyChart), or treatment plans that may cause significant side effects. A trained study navigator will confirm eligibility, obtain informed consent, and provide personalized support for 4 months. The navigator will contact participants at least once each month by phone, text message, email, MyChart, or video, based on participant preference. Support may include connecting participants with supportive care services and sharing concerns with their oncology care team.
The study will enroll 30 participants over 12 months, with a total study duration of 24 months. Participants will complete a needs assessment at the start of the study and again at 4 months, as well as a survey about their experience with the intervention at 4 months.
The main goal of the study is to determine whether the intervention is feasible, measured by the percentage of participants who complete the 4-month survey. The study will consider the intervention feasible if at least 50% of participants complete the survey. Other goals are to determine how many eligible patients agree to participate and how acceptable the intervention is to patients and oncology clinicians. The study will also explore changes in participants' unmet needs and describe how the navigation program is delivered, including navigator activities, participant engagement, and other factors that may affect implementation.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hannah C Winslow
- Numéro de téléphone: 919-984-0000
- E-mail: Hannah_Winslow@med.unc.edu
Sauvegarde des contacts de l'étude
- Nom: Allison Bell
- E-mail: allison_bell@med.unc.edu
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- University of North Carolina at Chapel Hill
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Contact:
- Hannah C Winslow
- Numéro de téléphone: 919-984-0000
- E-mail: Hannah_Winslow@med.unc.edu
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Chercheur principal:
- Jake Stein, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age 18-39 years at the time of consent.
- Histological or cytological evidence/confirmation of any invasive cancer.
- Currently receiving any form of systemic anti-cancer therapy
Exclusion Criteria:
- Patients only receiving surgery or radiation therapy (not systemic therapy)
- Unable to communicate in English.
- Patients do not have access to both phone and internet.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: AYA-PARTNER
Young adults between 18 and 39 years of age who are currently receiving systemic anti-cancer therapy or are expected to begin systemic anti-cancer therapy within a month.
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Participants will receive personalized support and navigation from a trained study navigator for 4 months, with contact at least once each month through phone, text message, email, MyChart, or video based on their preference.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility of the AYA-PARTNER Intervention
Délai: Up to 4 months
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The proportion of patients who consent to participate and maintain contact through the 4-month intervention by completing the 4-month survey.
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Up to 4 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Participant Enrollment Rate
Délai: Up to 4 months
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The proportion of eligible patients who consent to participate in the intervention after eligibility is confirmed.
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Up to 4 months
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Acceptability of the AYA-PARTNER Intervention
Délai: Up to 4 months
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Acceptability of the intervention will be measured at month 4 using an adapted 8-item Theoretical Framework of Acceptability (TFA) survey. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptability. |
Up to 4 months
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Provider Acceptability of the AYA-PARTNER Intervention
Délai: Up to 4 months
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Acceptability of the AYA-PARTNER intervention among oncology providers will be assessed at the end of the study using a provider version of the adapted 8-item Theoretical Framework of Acceptability (TFA) survey.
The survey will assess providers' perceptions of the intervention, including its appropriateness, ease of use, burden, and fit within routine clinical care.
Items will be rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptability.
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Up to 4 months
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Jacob Stein, MD, UNC Lineberger Comprehensive Cancer Center
Publications et liens utiles
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
Autres numéros d'identification d'étude
- LCCC2618
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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