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

Status: closed to accrual

This clinical trial 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 that is newly diagnosed or that has come back after a period of improvement (recurrent). 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 that is newly diagnosed or recurrent.

Inclusion Criteria

PRACTICE: Provide care for ≥ 50 newly diagnosed (new or recurrent) stage II-IV lung cancer patients annually
PRACTICE: Must be willing to complete an entry in the screening project for all dyads screened
PRACTICE: Able to identify 1-2 local practice referral coordinators willing to assist with CONNECT intervention delivery. Practices only able to identify one practice referral coordinator will be required to specify a back-up plan in the event that the practice referral coordinator becomes unavailable
PRACTICE: Able to identify a research and/or clinical champion for the study, distinct from the local practice referral coordinator(s)
CAREGIVER: 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
CAREGIVER: Must self-report being the primary caregiver when there is more than one caregiver for a patient
CAREGIVER: Must be ≥18 years of age, as this study is focused on the experience of adult patient-caregiver dyads
CAREGIVER: Must have access to the internet or be willing to use CONNECT in the clinic
CAREGIVER: Must have access to a telephone to complete sessions with the central caregiver navigator
PATIENT: Must have a current diagnosis of new (i.e., initial diagnosis) or recurrent stage II-IV lung cancer
PATIENT: Must be enrolled after the start of anticancer systemic therapy (+/- radiation therapy) with at least 9 weeks of any planned anticancer treatment remaining
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
PATIENT: 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

Exclusion Criteria

CAREGIVER: Self report currently receiving cancer treatment
CAREGIVER: Unable to read and communicate in English, as the CONNECT intervention is currently only available in English
PATIENT: Patients who have completed treatment for their lung cancer at the time of study enrollment
PATIENT: Enrolled in hospice care
PATIENT: Unable to read English and not willing to have someone read surveys for them

PRIMARY OBJECTIVE:

I. To assess the multi-site feasibility of the CONNECT intervention as measured by retention of caregivers at 12 weeks via a randomized pilot trial enrolling 120 lung cancer caregiver-patient dyads (CONNECT, n=40; usual care, n=40; generic resource list, n=40).

SECONDARY OBJECTIVES:

I. To further assess the multi-site feasibility of the CONNECT intervention as measured by accrual rate, participation, and retention of caregivers at 24 weeks.

II. To describe caregiver acceptability within each arm (CONNECT, usual care, and generic resource list).

III. To obtain data on time needed for practice participation and central navigation, referral processes, and communication processes between the local practice referral coordinator and central caregiver navigator.

EXPLORATORY OBJECTIVE:

I. To further assess the multi-site feasibility of the CONNECT intervention as measured by accrual rate, participation, and retention of patients at 12 and 24 weeks.

OUTLINE: Caregivers are randomized to 1 of 3 groups.

GROUP 1: Caregivers receive standard care and are then given a generic resource list at week 24.

GROUP 2: Caregivers receive a generic resource list at the start of the study.

GROUP 3: 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. Caregivers receive a letter at week 2 reminding them of their week 4 call with the caregiver navigator.

After completion of study intervention, participants are followed up at 4, 12, and/or 24 weeks.

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

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