Web-Based Support Program for Caregivers of Lung Cancer Patients

(CONNECT Trial)

Recruiting at 29 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

240 Participants Needed

Trial Summary

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 data supports the effectiveness of the Web-based Program treatment for caregivers of lung cancer patients?

Research shows that web-based systems like the Comprehensive Health Enhancement Support System (CHESS) can improve communication and decision-making for cancer patients and their caregivers, which may help them cope better with the challenges of cancer care. ^{1 2 3 4 5}

Is the Web-Based Support Program for Caregivers of Lung Cancer Patients safe?

Research on similar web-based programs for caregivers, like CHESS, shows they are generally safe and can help reduce stress and improve mood for caregivers of cancer patients. ^{2 6 7 8 9}

How is the Web-Based Support Program for Caregivers of Lung Cancer Patients different from other treatments?

This treatment is unique because it is a web-based program specifically designed to support caregivers of lung cancer patients, focusing on reducing their emotional and physical burden through information, communication, and coaching. Unlike traditional treatments that target the patient, this program addresses the needs of caregivers, helping them manage stress and improve their mood. ^{2 5 9 10 11}

What is the purpose of this trial?

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.

Research Team

Kathryn Weaver, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

I spend more than half of my day out of bed.

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

Exclusion Criteria

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

Caregiver must not self-report currently receiving cancer treatment

Patient must not be enrolled in hospice care

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Web-based cancer communication and decision making systems: connecting patients, caregivers, and clinicians for improved health outcomes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Using Web-based interventions to support caregivers of patients with cancer: a systematic review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcomes monitoring during lung cancer chemotherapy: A nested cohort within the PRO-TECT pragmatic trial (AFT-39). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Physical health, mental health, and life changes among family caregivers of patients with lung cancer. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Web-based support for spouses of patients with life-threatening illness cared for in specialized home care - A feasibility study. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

CHESS improves cancer caregivers' burden and mood: results of an eHealth RCT. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for informal caregivers of lung cancer patients: A systematic review. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Current perspectives on supportive care for lung cancer patients]. [2015]