A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources

NCT ID: NCT06383988

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2026-07-30

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.

Detailed Description

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.

Conditions

Stage II Lung Cancer; Stage III Lung Cancer; Stage IV Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Support for Caregiver - Personalized List

Intervention Type: OTHER

Receive personalized resource list

Internet-Based Intervention - CONNECT

Intervention Type: OTHER

Receive access to CONNECT tool

Patient Navigation

Intervention Type: BEHAVIORAL

Complete calls with caregiver navigator

Group 1 (Standard care followed by generic resource list)

Caregivers receive standard care and are then given a generic resource list at week 24.

Group Type: ACTIVE_COMPARATOR

Support for Caregiver - Generic List

Intervention Type: OTHER

Receive a generic resource list

Group 2 (Generic resource list)

Caregiver receive a generic resource list at the start of the study.

Group Type: ACTIVE_COMPARATOR

Support for Caregiver - Generic List

Intervention Type: OTHER

Receive a generic resource list

Interventions

Support for Caregiver - Generic List

Receive a generic resource list

Intervention Type: OTHER

Support for Caregiver - Personalized List

Receive personalized resource list

Intervention Type: OTHER

Internet-Based Intervention - CONNECT

Receive access to CONNECT tool

Intervention Type: OTHER

Patient Navigation

Complete calls with caregiver navigator

Intervention Type: BEHAVIORAL

Other Intervention Names

Patient Navigator Program

Eligibility Criteria

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

• 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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn Weaver, PhD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Kaiser Permanente-Franklin

Denver, Colorado, United States

Kaiser Permanente - Rock Creek

Lafayette, Colorado, United States

Kaiser Permanente - Lone Tree

Lone Tree, Colorado, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Augusta University Medical Center

Augusta, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Lake Regional Hospital

Osage Beach, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Wake Forest NCORP Research Base

Winston-Salem, North Carolina, United States

Community Medical Center

Scranton, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

MGC Hematology Oncology-Union

Union, South Carolina, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

ThedaCare Regional Medical Center - Neenah

Neenah, Wisconsin, United States

Countries

United States

Other Identifiers

NCI-2023-10870

Identifier Type: OTHER

Identifier Source: secondary_id

Lead Organization Identifier

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00112187

Identifier Type: -

Identifier Source: org_study_id