Contemporary clinical trials · 2026
Multi-site feasibility of a web-based and telephone navigation intervention to connect lung cancer caregivers in community oncology settings with resources: Protocol for the WF-2301CD Caregiver Oncology Needs Evaluation Tool (CONNECT) trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Nightingale Chandylen L, Snavely Anna C, Levine Beverly J, Turner Julie C, Farris Michael K, Tingen Martha S, Foust Melyssa, Graves Kristi, Danai Jenni, Price Sarah N, Asad Sarah S, Adonizio Christian S, Lesser Glenn J, Childrey Lauren, Weaver Kathryn E
Аннотация
BACKGROUND: Family caregivers of patients with lung cancer experience high levels of unmet needs, burden, and distress, yet systematic processes to identify and connect caregivers with resources are lacking in community oncology. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a hybrid intervention delivered through a combination of web-based components and telephone-based navigation to inform caregivers about resources, assess their needs, and connect them to tailored supportive care services. Initial pilot testing at a single academic center demonstrated feasibility and acceptability, but feasibility in community settings remains untested. In this study, we aim to assess the multi-site feasibility of CONNECT.
METHODS: This multi-site, randomized controlled pilot trial (WF-2301CD) is conducted through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Lung cancer caregiver-patient dyads (N = 120) are recruited from 12 community oncology practices and randomized to: CONNECT, generic resource list, or usual care. The primary objective is to assess multi-site feasibility, measured by caregiver retention at 12-weeks. Secondary objectives include evaluating caregiver accrual, participation, retention at 24-weeks, and acceptability, as well as process metrics. Exploratory objectives assess patient accrual, participation and retention. Data are collected via surveys at baseline, 12-, and 24-weeks, with additional process tracking by site staff and navigators.
DISCUSSION: This trial will provide critical data on the multi-site feasibility of implementing CONNECT in community oncology practices to inform protocol and design refinements for a future efficacy trial. If feasible, future efficacy testing will focus on the impact of CONNECT on caregiver burden and distress.NCT06383988.
METHODS: This multi-site, randomized controlled pilot trial (WF-2301CD) is conducted through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Lung cancer caregiver-patient dyads (N = 120) are recruited from 12 community oncology practices and randomized to: CONNECT, generic resource list, or usual care. The primary objective is to assess multi-site feasibility, measured by caregiver retention at 12-weeks. Secondary objectives include evaluating caregiver accrual, participation, retention at 24-weeks, and acceptability, as well as process metrics. Exploratory objectives assess patient accrual, participation and retention. Data are collected via surveys at baseline, 12-, and 24-weeks, with additional process tracking by site staff and navigators.
DISCUSSION: This trial will provide critical data on the multi-site feasibility of implementing CONNECT in community oncology practices to inform protocol and design refinements for a future efficacy trial. If feasible, future efficacy testing will focus on the impact of CONNECT on caregiver burden and distress.NCT06383988.