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Un programme Web pour aider les soignants des patients pulmonaires à connaître les ressources disponibles en matière de soins de soutien (CONNECT)

23 septembre 2026 mis à jour par: Wake Forest University Health Sciences

Planification d'oncologie communautaire multisite pour l'intervention CONNECT ciblant les soignants atteints du cancer du poumon

Clinical trial that tests the feasibility of a web based caregiver support resource, along with caregiver navigation sessions for caregivers of patients with stage II-IV lung cancer. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a novel web-based intervention designed for the community oncology setting, to systematically connect lung cancer caregivers with tailored supportive care resources. Lung cancer caregivers provide critical and challenging care for their loved ones and are at risk for their own negative psychosocial and physical outcomes. Implementing the CONNECT program along with caregiver navigation may provide additional support to caregivers of patients with stage II-IV lung cancer.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

This study is a multi-site randomized pilot trial enrolling 120 lung cancer caregiver-patient dyads (i.e., lung cancer caregivers (n=120) and their care-recipients (n=120)) across approximately 8-12 practices to assess the multi-site feasibility of a caregiver technology-based intervention (CONNECT) to identify caregivers' needs and connect them with supportive care resources. Caregivers will be randomized 1:1:1 to either the CONNECT intervention, usual care comparison group or generic resource list comparison group. CONNECT is a web-based intervention that empowers and educates caregivers about the benefits of supportive care services and systematically identifies unmet needs to connect lung cancer caregivers with tailored supportive care resources. The Central Caregiver Navigator will assist caregivers with resolving barriers to accessing resources and work with the Local Practice Referral Coordinator to process referrals. Caregivers and patients will complete measures at baseline (prior to caregiver randomization), and 12 and 24 weeks after baseline. Feasibility measures (retention, accrual rates, and participation) will be evaluated to inform the future trial. The Local Practice Referral Coordinator for each practice will report on time needed for practice participation, referral processes, and communication processes with the Central Caregiver Navigator.

Participants (i.e., patients or care-recipients) will be asked to complete study surveys at three time points:

  • After consenting and before randomization of participant and caregiver. (Initial survey)
  • Approximately 12 weeks after completing the first survey (12-week survey)
  • Approximately 24 weeks after completing the first survey (24-week survey)

Each survey will take about 30-45 minutes to complete. The forms will ask about things such as demographics (sex, race, etc.), cancer symptoms, satisfaction with cancer care and health behaviors. You don't have to answer any question that makes you feel uncomfortable. These surveys can be done remotely over the internet, in the clinic, by phone or by mail.

Caregivers will also complete surveys at three time points and will be assigned to 1 of 3 study groups:

  • Group 1 will be given the usual care provided at your clinic. At the completion of the study, this group will be given the generic supportive care resource list for their use that Group 2 received.
  • Group 2 will be provided with a generic supportive care resource list.
  • Group 3 will be asked to watch a brief video and complete the web-based CONNECT program either in the clinic or on your own device. The CONNECT program is designed to help identify any unmet needs and connect the caregiver with tailored supportive care resources, based on specific needs. The CONNECT Navigator will follow-up with within 2 business days of completion of the program and again 4 weeks later.

Caregiver Participants (Group 1, 2 and 3) will be asked to complete study surveys at three time points:

  • After consenting and before randomization of participant and caregiver. (Initial survey)
  • Approximately 12 weeks after completing the first survey (12-week survey)
  • Approximately 24 weeks after completing the first survey (24-week survey)

Each survey will take about 35-45 minutes to complete. The forms will ask about things such as demographics (sex, race, etc.), caregiving experience, use of supportive care resources, quality of life, mood, and social needs (housing, transportation, utilities, etc). You don't have to answer any question that makes you feel uncomfortable.

Type d'étude

Interventionnel

Inscription (Estimé)

216

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Colorado
      • Denver, Colorado, États-Unis, 80205
        • Kaiser Permanente-Franklin
      • Lafayette, Colorado, États-Unis, 80026
        • Kaiser Permanente - Rock Creek
      • Lone Tree, Colorado, États-Unis, 80124
        • Kaiser Permanente - Lone Tree
    • Delaware
      • Millville, Delaware, États-Unis, 19967
        • Beebe South Coastal Health Campus
      • Rehoboth Beach, Delaware, États-Unis, 19971
        • Beebe Health Campus
    • Georgia
      • Augusta, Georgia, États-Unis, 30912
        • Augusta University Medical Center
    • Hawaii
      • Honolulu, Hawaii, États-Unis, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • ‘Aiea, Hawaii, États-Unis, 96701
        • Hawaii Cancer Care - Westridge
    • Missouri
      • Osage Beach, Missouri, États-Unis, 65065
        • Lake Regional Hospital
      • Springfield, Missouri, États-Unis, 65807
        • CoxHealth South Hospital
    • New York
      • The Bronx, New York, États-Unis, 10461
        • Montefiore Medical Center-Einstein Campus
    • North Carolina
      • Winston-Salem, North Carolina, États-Unis, 27157
        • Wake Forest NCORP Research Base
    • Pennsylvania
      • Scranton, Pennsylvania, États-Unis, 18510
        • Community Medical Center
      • Wilkes-Barre, Pennsylvania, États-Unis, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Gaffney, South Carolina, États-Unis, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, États-Unis, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, États-Unis, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greer, South Carolina, États-Unis, 29651
        • Gibbs Cancer Center-Pelham
      • Spartanburg, South Carolina, États-Unis, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, États-Unis, 29379
        • MGC Hematology Oncology-Union
    • Wisconsin
      • Appleton, Wisconsin, États-Unis, 54911
        • ThedaCare Regional Cancer Center
      • Green Bay, Wisconsin, États-Unis, 54311
        • Aurora BayCare Medical Center
      • Kenosha, Wisconsin, États-Unis, 53142
        • Aurora Cancer Care-Kenosha South
      • Milwaukee, Wisconsin, États-Unis, 53215
        • Aurora Saint Luke's Medical Center
      • Neenah, Wisconsin, États-Unis, 54956
        • ThedaCare Regional Medical Center - Neenah

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Patient Inclusion Criteria:

  • Must be ≥ 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads
  • Must have a current diagnosis of new (i.e., initial diagnosis) or recurrent stage II-IV lung cancer
  • Must be enrolled after the start of anticancer systemic therapy (+/- radiation therapy) with at least 9 weeks of any planned anticancer treatment remaining
  • Must be ambulatory and up (i.e., not bedridden) more than 50% of waking hours
  • Must self-report receiving informal (i.e., not professional) care from a caregiver who meets the study caregiver criteria and who is willing to participate

Caregiver Inclusion Criteria:

  • Must be ≥18 years of age, as this study is focused on the experience of adult patient-caregiver dyads
  • Must self-report providing informal (i.e. not professional) care during cancer treatment for a patient who meets the patient criteria and who is willing to participate
  • Must have access to the internet at home or be willing to use CONNECT in the clinic
  • Must have access to telephone to complete sessions with the central caregiver navigator

Patient Exclusion Criteria:

  • Patients who have completed treatment for their lung cancer at the time of study enrollment
  • Enrolled in hospice care
  • Unable to read and English and not willing to have someone read surveys for them

Caregiver Exclusion Criteria:

  • Self-report currently receiving cancer treatment
  • Unable to read and communicate in English, as the CONNECT intervention is currently only available in English

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Group 1 (Standard care followed by generic resource list)

Caregivers receive standard care and are then given a generic resource list at week 24.
Autre: Support for Caregiver - Generic List

Receive a generic resource list
Comparateur actif: Group 2 (Generic resource list)

Caregiver receive a generic resource list at the start of the study.
Autre: Support for Caregiver - Generic List

Receive a generic resource list
Expérimental: Group 3 (CONNECT, personalized list, and navigation)

Caregivers receive access to the CONNECT tool, watch an educational video on self care and receive a personalized list of resources based on caregiver preferences. Caregivers also receive access to and complete at least 2 calls, at baseline and at week 4, with a caregiver navigator to review the resource list and address any additional needs.
Autre: Support for Caregiver - Personalized List

Receive personalized resource list

Autre: Internet-Based Intervention - CONNECT

Receive access to CONNECT tool

Comportemental: Patient Navigation

Complete calls with caregiver navigator

Autres noms:
  • Programme de navigateur des patients

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Caregiver retention at 12 weeks
Délai: At 12 weeks

Calculated as the following: Number of caregivers who complete at least 75% of the 12-week assessments divided by the number randomized. Retention will be estimated and reported along with an exact 95% confidence interval.
At 12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Caregiver accrual rate
Délai: Upon completion of recruitment, approximately 12 months

Number of caregivers who agree to participate divided by the number of months of recruitment
Upon completion of recruitment, approximately 12 months
Caregiver participation
Délai: Upon completion of recruitment, approximately 12 months

Proportion of eligible caregivers who agreed to participate
Upon completion of recruitment, approximately 12 months
Caregiver retention at 24 weeks
Délai: At 24 weeks

Number of caregivers who complete at least 75% of the 24-week assessments divided by the number randomized.
At 24 weeks
Caregiver acceptability
Délai: At 12 weeks

Self-report survey developed for this study to assess the degree to which caregivers found different aspects of CONNECT, the generic resource list, or usual care helpful using a Likert response from 0 (Not at all) to 5 (Very Much)
At 12 weeks
Average time (minutes) needed for training for Local Practice Referral Coordinator
Délai: At completion of training, up to 6 months

Will be summarized across practices using mean, median, standard deviation and interquartile range.
At completion of training, up to 6 months
Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator
Délai: At completion of training, up to 6 months

Will be summarized using appropriate descriptive statistics.
At completion of training, up to 6 months
Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database
Délai: At conclusion of practice intervention activities, an average of 18 months

Will be summarized across practices using mean, median, standard deviation and interquartile range.
At conclusion of practice intervention activities, an average of 18 months
Frequency of needed resource updates in the CONNECT database
Délai: Up to completion of practice intervention activities, an average of 18 months

Will be summarized across practices using mean, median, standard deviation and interquartile range
Up to completion of practice intervention activities, an average of 18 months
Average time (minutes) spent by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
Délai: Up to completion of practice intervention activities, an average of 18 months

Will be summarized across practices using mean, median, standard deviation and interquartile range.
Up to completion of practice intervention activities, an average of 18 months
Modality of contact (e.g. phone, virtual web meeting, email) made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
Délai: Up to completion of practice intervention activities, an average of 18 months

Will be summarized using appropriate descriptive statistics.
Up to completion of practice intervention activities, an average of 18 months
Number of contacts made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
Délai: Up to completion of practice intervention activities, an average of 18 months

Will be summarized across practices using mean, median, standard deviation and interquartile range.
Up to completion of practice intervention activities, an average of 18 months
Number of referrals facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator
Délai: Up to completion of practice intervention activities, an average of 18 months

Will be summarized across practices using mean, median, standard deviation and interquartile range.
Up to completion of practice intervention activities, an average of 18 months
Type of referrals (e.g., in person, online) facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator
Délai: Up to completion of practice intervention activities, an average of 18 months

Will be summarized using appropriate descriptive statistics.
Up to completion of practice intervention activities, an average of 18 months
Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator
Délai: Up to completion of practice intervention activities, an average of 18 months

Will be summarized across practices using mean, median, standard deviation and interquartile range.
Up to completion of practice intervention activities, an average of 18 months
Modalities used for communication (e.g., phone, virtual web meeting, email) for Central Caregiver Navigator and Local Practice Referral Coordinator
Délai: Up to completion of practice intervention activities, an average of 18 months

Will be summarized using appropriate descriptive statistics.
Up to completion of practice intervention activities, an average of 18 months
Improvements for the future trial from Local Practice Referral Coordinator's perspectives from a survey at the end of the study
Délai: At completion of practice intervention activities, an average of 18 months

Will be summarized using appropriate descriptive statistics.
At completion of practice intervention activities, an average of 18 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Patient accrual rate
Délai: Upon completion of recruitment, approximately 12 months

Number of patients who agree to participate divided by the number of months of recruitment
Upon completion of recruitment, approximately 12 months
Patient participation rate
Délai: Upon completion of recruitment, approximately 12 months

Proportion of eligible patients who agreed to participate
Upon completion of recruitment, approximately 12 months
Patient retention at 12 weeks
Délai: At 12 weeks

Number of patients who complete at least 75% of the 12-week assessments divided by the number randomized
At 12 weeks
Patient retention at 24 weeks
Délai: At 24 weeks

Number of patients who complete at least 75% of the 24-week assessments divided by the number randomized
At 24 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Wake Forest University Health Sciences

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chaise d'étude: Kathryn Weaver, PhD, Wake Forest University Health Sciences

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 novembre 2024

Achèvement primaire (Estimé)

30 décembre 2026

Achèvement de l'étude (Estimé)

30 décembre 2026

Dates d'inscription aux études

Première soumission

15 avril 2024

Première soumission répondant aux critères de contrôle qualité

22 avril 2024

Première publication (Réel)

25 avril 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB00112187
  • NCI-2023-10870 (Autre identifiant: NCI Trial Identifier)
  • Lead Organization Identifier (Autre identifiant: WF-2301CD)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

Délai de partage IPD

6 months after publication for a 2 year duration

Critères d'accès au partage IPD

upon request to NCORP@wakehealth.edu

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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