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Internetowy program pomagający opiekunom pacjentów z płucami poznać dostępne zasoby opieki wspomagającej (CONNECT)

23 września 2026 zaktualizowane przez: Wake Forest University Health Sciences

Społeczne planowanie onkologiczne w wielu ośrodkach dla interwencji CONNECT skierowanej do opiekunów chorych na raka płuc

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

216

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Group 1 (Standard care followed by generic resource list)

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

Receive a generic resource list
Aktywny komparator: Group 2 (Generic resource list)

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

Receive a generic resource list
Eksperymentalny: 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.
Inny: Support for Caregiver - Personalized List

Receive personalized resource list

Inny: Internet-Based Intervention - CONNECT

Receive access to CONNECT tool

Behawioralne: Patient Navigation

Complete calls with caregiver navigator

Inne nazwy:
  • Program Patient Navigator

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Caregiver retention at 12 weeks
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Caregiver accrual rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Patient accrual rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At 24 weeks

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Wake Forest University Health Sciences

Współpracownicy

National Cancer Institute (NCI)

Śledczy

  • Krzesło do nauki: Kathryn Weaver, PhD, Wake Forest University Health Sciences

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

11 listopada 2024

Zakończenie podstawowe (Szacowany)

30 grudnia 2026

Ukończenie studiów (Szacowany)

30 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

15 kwietnia 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 kwietnia 2024

Pierwszy wysłany (Rzeczywisty)

25 kwietnia 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

6 months after publication for a 2 year duration

Kryteria dostępu do udostępniania IPD

upon request to NCORP@wakehealth.edu

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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