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Web-Based Support Program for Caregivers of Lung Cancer Patients (CONNECT Trial)

N/A

Waitlist Available

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be ambulatory and up (i.e., not bedridden) more than 50% of waking hours

Patient must be ≥ 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads

Must not have

Patient must be unable to read and English and not willing to have someone read surveys for them

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at completion of practice intervention activities, an average of 18 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new online resource called CONNECT for caregivers of patients with advanced lung cancer. The resource aims to connect caregivers with tailored support services. Caregivers play a crucial role in caring for

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions like online support systems and information provision, there are no direct medical side effects associated with drugs or procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My lung cancer is at stage II, III, or IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot read English and do not want help with reading surveys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at conclusion of practice intervention activities, an average of 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at conclusion of practice intervention activities, an average of 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at conclusion of practice intervention activities, an average of 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caregiver retention at 12 weeks

Secondary study objectives

Average time (minutes) needed for training for Local Practice Referral Coordinator

Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator

Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database

+13 more

Other study objectives

Patient accrual rate

Patient participation rate

Patient retention at 12 weeks

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 3 (CONNECT, personalized list, and navigation)Experimental Treatment3 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 Control1 Intervention

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

Group III: Group 2 (Generic resource list)Active Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

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