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Een webgebaseerd programma om zorgverleners van longpatiënten te helpen meer te weten te komen over beschikbare ondersteunende zorgbronnen (CONNECT)

23 september 2026 bijgewerkt door: Wake Forest University Health Sciences

Multi-site community oncologieplanning voor de CONNECT-interventie gericht op longkankerzorgverleners

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

216

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Group 1 (Standard care followed by generic resource list)

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

Receive a generic resource list
Actieve vergelijker: Group 2 (Generic resource list)

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

Receive a generic resource list
Experimenteel: 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.
Ander: Support for Caregiver - Personalized List

Receive personalized resource list

Ander: Internet-Based Intervention - CONNECT

Receive access to CONNECT tool

Gedragsmatig: Patient Navigation

Complete calls with caregiver navigator

Andere namen:
  • Patient Navigator-programma

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Caregiver retention at 12 weeks
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Caregiver accrual rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient accrual rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At 24 weeks

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Kathryn Weaver, PhD, Wake Forest University Health Sciences

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 november 2024

Primaire voltooiing (Geschat)

30 december 2026

Studie voltooiing (Geschat)

30 december 2026

Studieregistratiedata

Eerst ingediend

15 april 2024

Eerst ingediend dat voldeed aan de QC-criteria

22 april 2024

Eerst geplaatst (Werkelijk)

25 april 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

23 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

6 months after publication for a 2 year duration

IPD-toegangscriteria voor delen

upon request to NCORP@wakehealth.edu

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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