Web-Based Support Program for Caregivers of Lung Cancer Patients

(CONNECT Trial)

Enrolling by invitation at 33 trial locations

Overseen By Karen Craver

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Hospice care, Cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based support program for caregivers of lung cancer patients. The goal is to determine if personalized resources and navigation support enhance caregivers' well-being while caring for someone with stage II-IV lung cancer. Participants will receive either standard care, a generic resource list, or a personalized resource list with additional support. Caregivers assisting someone with stage II-IV lung cancer and having internet access might be suitable for this trial. As an unphased trial, it offers caregivers the chance to access potentially beneficial resources and support tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this web-based program is safe for caregivers?

Research has shown that online programs like CONNECT are generally safe for caregivers. One study found that the CONNECT program improved caregivers' mood, reduced their stress, and increased their confidence in caregiving for advanced cancer patients. No serious negative effects were reported from using this type of program.

Other studies also indicate that technology-based support is well-received by caregivers, with no major safety concerns reported. The program's online nature makes it easy to access and use, which benefits caregivers with busy schedules.

Overall, the CONNECT tool appears to be a safe and useful resource for caregivers of lung cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-Based Support Program for caregivers of lung cancer patients because it offers a personalized and interactive approach, unlike the standard care options which typically involve generic resources. The program includes the CONNECT tool that tailors resources to individual caregiver preferences, enhancing the support system. Additionally, caregivers have scheduled calls with a navigator to address specific needs and ensure they utilize the resources effectively. This personalized and guided approach aims to improve caregiver well-being and, indirectly, patient care, making it a promising development in caregiver support strategies.

What evidence suggests that this web-based program is effective for supporting caregivers of lung cancer patients?

In this trial, caregivers of lung cancer patients will join different groups to evaluate various support strategies. Research has shown that the CONNECT web-based program, provided to participants in Group 3, boosts caregivers' confidence in their caregiving skills. Although it does not reduce stress or improve mood, it enhances their sense of capability and empowerment. This program connects caregivers to resources tailored to their needs, offering personalized support and advice. By using this tool, caregivers can better manage challenges and access helpful resources. This support is crucial, as caregivers often experience high stress and need guidance to care for themselves. ^{1 2 3 6 7}

Who Is on the Research Team?

Kathryn Weaver, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adult caregivers providing unpaid care to someone with stage II-IV lung cancer. Caregivers must be able to use the internet and have a phone for navigation sessions. The patient must have started treatment with at least 9 weeks left, and both caregiver and patient need an ECOG status of 0-2.

Inclusion Criteria

I have a caregiver willing to participate in the study with me.

Caregiver must have access to the internet at home or be willing to use CONNECT in the clinic

Caregiver must have access to telephone to complete sessions with the central caregiver navigator

Exclusion Criteria

Patient must not be enrolled in hospice care

Patient must not be post-treatment survivors at the time of study enrollment

Caregiver must not self-report currently receiving cancer treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete initial surveys to assess demographics, cancer symptoms, and caregiving experience

1 week

1 visit (in-person or remote)

Intervention

Caregivers are randomized into one of three groups: CONNECT intervention, usual care, or generic resource list. CONNECT group receives personalized resources and navigator support

24 weeks

2 calls with caregiver navigator (CONNECT group)

Follow-up

Participants complete follow-up surveys to assess retention, satisfaction, and resource utilization

24 weeks

Surveys at 12 and 24 weeks (remote or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Web-based Program

Trial Overview The study tests a web-based program called CONNECT that matches caregivers of lung cancer patients with supportive resources. It includes personalized support lists and caregiver navigation sessions to help manage their responsibilities.

How Is the Trial Designed?

Group I: Group 3 (CONNECT, personalized list, and navigation) Experimental Treatment 3 Interventions

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 II: Group 1 (Standard care followed by generic resource list) Active Control 1 Intervention

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

Group III: Group 2 (Generic resource list) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The My Child's Safety web-based education program significantly improved caregivers' awareness of patient safety for children with cancer, as shown by pre- and post-test results.

After using the program, caregivers felt more empowered to ask questions about procedures and treatments, indicating an increase in their understanding of their rights during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of My Child's Safety Web-Based Program for Caregivers of Children with Cancer in South Korea. Park, BK., Lee, E.[2021]

In a study of 1361 patients undergoing radiation therapy for locally advanced lung cancer, over half (53%) reported significant declines in their quality of life (QoL) by the end of treatment, indicating that treatment can have a substantial impact on patient well-being.

While clinician-reported adverse events (AEs) were linked to declines in QoL, the correlation was only moderate, suggesting that patient-reported outcomes (PROs) are crucial for understanding the full impact of treatment and may help identify when interventions are needed to improve patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Physician- and Patient-Reported Symptoms in Patients Treated With Definitive Radiation Therapy for Locally Advanced Lung Cancer in a Statewide Consortium. Wilkie, JR., Hochstedler, KA., Schipper, MJ., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11099917

Multi-site Community Oncology Planning for the CONNECT ... The overall goal of this program of research is to develop innovative and scalable programs to improve supportive care delivery for cancer caregivers in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10191108/

Examining Caregiver Outcomes in the CONNECT Intervention ... Caregivers in CONNECT did not experience improved burden or mood, however, they reported higher self-efficacy compared to caregivers receiving standard care.

3. withpower.com withpower.com/trial/phase-stage-ii-lung-cancer-6-2024-5643c

Web-Based Support Program for Caregivers of Lung Cancer ... The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a novel web-based intervention designed for the community oncology setting, to systematically connect ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-10870

A Web-based Program to Help Caregivers of Lung Patients ... This clinical trial tests the feasibility of a web based caregiver support resource, along with caregiver navigation sessions for caregivers of patients ...

5. ascopubs.org ascopubs.org/doi/10.1200/jco.2015.33.29_suppl.90

A web-based program to engage informal caregivers ... "Cancer CarePartners" is a system designed to engage informal caregivers to support patients' quality of life as they receive chemotherapy. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6661176/

Improving Family Caregiver and Patient Outcomes in Lung ... To describe the study protocol of the Multimedia Self-Management Intervention (SMI) to prepare patients and family caregivers (FCGs) for lung cancer surgery.

7. nature.com nature.com/articles/s41746-025-01913-7

Systematic review on the technology's role in supporting ... This systematic review examines the role of technology-based interventions in supporting lung cancer patients during their treatment.