A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources
CONNECT
Multi-Site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers
3 other identifiers
interventional
216
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 25, 2024
CompletedStudy Start
First participant enrolled
November 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
April 13, 2026
April 1, 2026
1.6 years
April 15, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Caregiver retention 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
Secondary Outcomes (16)
Caregiver accrual rate
Upon completion of recruitment, approximately 12 months
Caregiver participation
Upon completion of recruitment, approximately 12 months
Caregiver retention at 24 weeks
At 24 weeks
Caregiver acceptability
At 12 weeks
Average time (minutes) needed for training for Local Practice Referral Coordinator
At completion of training, up to 6 months
- +11 more secondary outcomes
Other Outcomes (4)
Patient accrual rate
Upon completion of recruitment, approximately 12 months
Patient participation rate
Upon completion of recruitment, approximately 12 months
Patient retention at 12 weeks
At 12 weeks
- +1 more other outcomes
Study Arms (3)
Group 1 (Standard care followed by generic resource list)
ACTIVE COMPARATORCaregivers receive standard care and are then given a generic resource list at week 24.
Group 2 (Generic resource list)
ACTIVE COMPARATORCaregiver receive a generic resource list at the start of the study.
Group 3 (CONNECT, personalized list, and navigation)
EXPERIMENTALCaregivers 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.
Interventions
Receive access to CONNECT tool
Complete calls with caregiver navigator
Receive a generic resource list
Receive personalized resource list
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- Self-report currently receiving cancer treatment
- Unable to read and communicate in English, as the CONNECT intervention is currently only available in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Kaiser Permanente-Franklin
Denver, Colorado, 80205, United States
Kaiser Permanente - Rock Creek
Lafayette, Colorado, 80026, United States
Kaiser Permanente - Lone Tree
Lone Tree, Colorado, 80124, United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701, United States
Lake Regional Hospital
Osage Beach, Missouri, 65065, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin, 54956, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kathryn Weaver, PhD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 25, 2024
Study Start
November 11, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication for a 2 year duration
- Access Criteria
- upon request to NCORP@wakehealth.edu
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.