Ein webbasiertes Programm, das Betreuern von Lungenpatienten dabei hilft, sich über verfügbare unterstützende Pflegeressourcen zu informieren (CONNECT)
Community-onkologische Planung an mehreren Standorten für die CONNECT-Intervention für Lungenkrebs-Betreuer
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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80205
- Kaiser Permanente-Franklin
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Lafayette, Colorado, Vereinigte Staaten, 80026
- Kaiser Permanente - Rock Creek
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Lone Tree, Colorado, Vereinigte Staaten, 80124
- Kaiser Permanente - Lone Tree
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-
Delaware
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Millville, Delaware, Vereinigte Staaten, 19967
- Beebe South Coastal Health Campus
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Rehoboth Beach, Delaware, Vereinigte Staaten, 19971
- Beebe Health Campus
-
-
Georgia
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Augusta, Georgia, Vereinigte Staaten, 30912
- Augusta University Medical Center
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Hawaii
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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‘Aiea, Hawaii, Vereinigte Staaten, 96701
- Hawaii Cancer Care - Westridge
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Missouri
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Osage Beach, Missouri, Vereinigte Staaten, 65065
- Lake Regional Hospital
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Springfield, Missouri, Vereinigte Staaten, 65807
- CoxHealth South Hospital
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New York
-
The Bronx, New York, Vereinigte Staaten, 10461
- Montefiore Medical Center-Einstein Campus
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North Carolina
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Winston-Salem, North Carolina, Vereinigte Staaten, 27157
- Wake Forest NCORP Research Base
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Pennsylvania
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Scranton, Pennsylvania, Vereinigte Staaten, 18510
- Community Medical Center
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Wilkes-Barre, Pennsylvania, Vereinigte Staaten, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
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South Carolina
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Gaffney, South Carolina, Vereinigte Staaten, 29341
- Gibbs Cancer Center-Gaffney
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Greenville, South Carolina, Vereinigte Staaten, 29615
- Prisma Health Cancer Institute - Eastside
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Greenville, South Carolina, Vereinigte Staaten, 29605
- Prisma Health Cancer Institute - Butternut
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Greer, South Carolina, Vereinigte Staaten, 29651
- Gibbs Cancer Center-Pelham
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Spartanburg, South Carolina, Vereinigte Staaten, 29303
- Spartanburg Medical Center
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Union, South Carolina, Vereinigte Staaten, 29379
- MGC Hematology Oncology-Union
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Wisconsin
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Appleton, Wisconsin, Vereinigte Staaten, 54911
- ThedaCare Regional Cancer Center
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Green Bay, Wisconsin, Vereinigte Staaten, 54311
- Aurora BayCare Medical Center
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Kenosha, Wisconsin, Vereinigte Staaten, 53142
- Aurora Cancer Care-Kenosha South
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Milwaukee, Wisconsin, Vereinigte Staaten, 53215
- Aurora Saint Luke's Medical Center
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Neenah, Wisconsin, Vereinigte Staaten, 54956
- ThedaCare Regional Medical Center - Neenah
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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. |
Receive a generic resource list |
|
Aktiver Komparator: Group 2 (Generic resource list)
Caregiver receive a generic resource list at the start of the study. |
Receive a generic resource list |
|
Experimental: 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. |
Receive personalized resource list Receive access to CONNECT tool Complete calls with caregiver navigator
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Caregiver retention at 12 weeks
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Caregiver accrual rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient accrual rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At 24 weeks
|
Number of patients who complete at least 75% of the 24-week assessments divided by the number randomized |
At 24 weeks
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Kathryn Weaver, PhD, Wake Forest University Health Sciences
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Lungentumoren
- Verwaltung des Gesundheitswesens
- Therapeutika
- Patientenversorgung
- Gesundheitsdienste
- Belegschaft und Dienstleistungen für Gesundheitseinrichtungen
- Patientenversorgung Management
- Umfassende Gesundheitsversorgung
- Patientenzentrierte Pflege
- Primärgesundheitsversorgung
- Palliativpflege
- Patientennavigation
Andere Studien-ID-Nummern
- IRB00112187
- NCI-2023-10870 (Andere Kennung: NCI Trial Identifier)
- Lead Organization Identifier (Andere Kennung: WF-2301CD)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
6 months after publication for a 2 year duration
IPD-Sharing-Zugriffskriterien
upon request to NCORP@wakehealth.edu
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