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L'essai clinique NCT06963723 (PROOF) pour Cancer avancé, Cancer métastatique est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer (PROOF)
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06963723 (PROOF) est un essai interventionnel pour Cancer avancé, Cancer métastatique. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 juillet 2025, avec un objectif de 1 000 participants. Dirigé par Alliance Foundation Trials, LLC., l'essai devrait être terminé d'ici le 1 avril 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 mai 2025.
Résumé succinct
The study aims to determine whether monthly remote digital financial hardship screening among adults with advanced/metastatic cancer, undergoing outpatient systemic therapy with non-curative intent, improves patient-centered outcomes, including financial worry, health-related quality of life (HRQoL), symptom burden, patient-reported cancer treatment adherence, and exploratory outcomes of overall survival, patient-reported economic burden, patient-reported support received, patient-reported financial coping strategies, and health insurance literacy.
Description détaillée
Financial hardship is a common problem that affects patients treated for advanced cancer and leads to poor outcomes related to financial worry, health related quality of life (HRQoL), symptom burden, treatment adherence, and overall survival. Prior studies have shown that financial navigation may be an effective strategy to attenuate the impact of financial hardship. However, patients and clinicians have identified communication as a key barrier that prevents patients from being connected to sources of financial assistance. To address this critical gap in patient care, and based on strong preliminary data that financial hardship screening may improve patient outcomes, this financial hardship screening intervention will help connect patients to financial navigation resources. It is hypothesized that by connecting patients experiencing financial hardship with financial navigation resources, this intervention will lead to improved patient-centered outcomes.
Titre officiel
Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer
Conditions
Cancer avancéCancer métastatiqueAutres identifiants de l'essai
- PROOF
- A232403
Numéro NCT
Date de début (réel)
2025-07-01
Dernière mise à jour publiée
2025-05-09
Date de fin (estimée)
2029-04-01
Inscription (estimée)
1 000
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Financial Toxicity
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalIntervention Participants randomized to the intervention arm will complete their monthly screening using the single-item screening question (every 4 weeks for 12 months). | Financial Hardship Screening Financial Hardship Screening and Financial Needs Assessment |
Comparateur actifEnhanced Usual Care Participants randomized to receive enhanced usual care will not be systematically screened for financial hardship through the electronic PRO Core system. | Soins habituels améliorés Enhanced Usual Care |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Financial Worry | Patient-reported financial worry will be measured by the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) total scale.
Possible score range: 0 to 44, with higher scores indicating better outcomes | 6 months |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Health-related quality of life | Patient-reported health-related quality of life will be measured by the Functional Assessment of Cancer Therapy-General (FACT-G) total scale.
Possible score range: 0 to 108, with higher scores indicating better outcomes | 6 months |
Symptom burden | Patient-reported symptom burden will be measured by the Functional Assessment of Cancer Therapy-General (FACT-G) physical well-being scale.
Possible score range: 0 to 28, with higher scores indicating better outcomes | 6 months |
Cancer treatment adherence | Patient-reported cancer treatment adherence will be measured by the Domains of Subjective Extent of Nonadherence-Cancer (DOSE-Nonadherence-Cancer) extent of nonadherence scale, with patients classified as adherent (i.e., all responses of "none of the time" on the DOSE-Nonadherence-Cancer items for missing, skipping, or not taking a dose of medicine) versus nonadherent | 6 months |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
21 Years
Sexes éligibles
Tous
- Minimum age of 21
- Understands English and/or Spanish
- Has a diagnosis of advanced/metastatic cancer
- Currently undergoing systemic therapy (enteral or parenteral) with non-curative intent
- Has been receiving treatment for at least 2 months
- Life expectancy of at least 6 months, in the opinion of the treating oncologist
- Cognitively able to give informed consent
- Under the age of 21
- Does not understand English or Spanish
- Has cognitive deficits that would preclude understanding of consent form and/or questionnaires
- Undergoing treatment with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer, primary curative therapy for testis cancer or lymphoma)
- Not undergoing systemic therapy (enteral or parenteral) with non-curative intent
- Receiving treatment for fewer than 2 months
- Life expectancy is less than 6 months, in the opinion of the treating oncologist
Contact central de l'essai
Contact: AFT Quality Management Group Inbox, 617-732-8727, [email protected]
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