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Набор скоро начнётся NCT07664436

Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS)

Без фазы С лечением Cancer Financial Burden Financial Toxicity Screening Tool

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Financial counseling and navigation.
Кому может быть актуально
Состояния в реестре: Cancer, Financial Burden, Financial Toxicity, Screening Tool. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Screening and referral program to proactively identify financial hardship in adult patients with cancer and connect those at-risk with education, counseling, and resources. Patients with cancer will be screened as part of routine care and referred to available resources at their institution, following the referral processes developed and mapped in Aim 1.

Подробное описание

In Aim 1, we will interview up to 30 clinical leaders and front-line staff across the two healthcare systems and community-based practices to understand workflows and opportunities for I-ACCESS integration. Assessment constructs will focus on understanding structural characteristics (including information technology infrastructure), available resources, culture, compatibility, relational connections, communications, and access to knowledge. These data will inform the creation of tailored process maps to outline processes and procedures to prepare each site for I-ACCESS implementation and elucidate when, how, and by whom I-ACCESS screening should be done.

In Aim 2, we will implement I-ACCESS as part of routine clinical practice for eight months at each site. Using a pre-/post-approach, we will examine whether I-ACCESS screening increases the number of financial counseling and oncology social work referrals (primary outcome). We will also examine counseling dispositions, receipt of services among those referred to financial support, and the predictive accuracy of the screening tool (secondary outcomes).

In Aim 3, we will analyze approximately 225 patient and 25 clinician surveys, informed by the Practical, Robust, Implementation and Sustainability Model, to gather feedback on I-ACCESS delivery, procedures, and barriers/facilitators to implementation. Based upon survey findings, we will then focus on key implementation determinants and outcomes through in-depth, semi-structured interviews with up to 40 stakeholders. Stakeholders will include patients, caregivers, healthcare providers, financial counselors, clinical support staff, and hospital administration at participating clinical sites.

Вмешательства

  • Поведенческое Financial counseling and navigation
    Patients who screen positive for financial toxicity on the 2-question screener tool, will be referred to available counseling or navigation resources available at each site.

Первичные конечные точки

  • Screening completion [Срок оценки: From enrollment to the end of the intervention at 8 months.]
  • Rate of referral assistance [Срок оценки: From enrollment to the end of the intervention at 8 months.]
Вторичные конечные точки (8)
  • Type of referral [Срок оценки: From enrollment to the end of the intervention at 8 months.]
  • Counseling content [Срок оценки: From enrollment to the end of the intervention at 8 months.]
  • Applications for assistance [Срок оценки: From enrollment to the end of the intervention at 8 months.]
  • Referrals to external resources [Срок оценки: From enrollment to the end of the intervention at 8 months.]
  • Predictive accuracy of tool [Срок оценки: From enrollment through the end of data analysis at 12 months]
  • Acceptability of Intervention Measure [Срок оценки: 4-6 months after implementation of I-ACCESS]
  • Intervention Appropriateness Measure [Срок оценки: 4-6 months after implementation of I-ACCESS]
  • Feasibility of Intervention Measure [Срок оценки: 4-6 months after intervention completion]

Критерии участия

Критерии включения

  • Patients: Treatment for cancer at study site, over age 18 years, speak/read English or Spanish; Caregivers: Identified caregiver of a patient with cancer offered financial hardship screening, over age 18 years, speak/read English or Spanish; Staff/Clinicians: Involvement with I-ACCESS pilot implementation; over age 18 years, speak/read English or Spanish

Критерии исключения

  • Unable to read of speak English or Spanish
  • Under the age of 18 years old

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 4 центра
  • Perlmutter Cancer Center — New York
  • Cone Health Alamance Regional — Burlington
  • University of North Carolina at Chapel Hill — Chapel Hill
  • UNC Health Pardee — Hendersonville

Идентификаторы

NCT: NCT07664436 · 25-1413

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗