Clinical trial NCT06383988: A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources
Official title: Multi-Site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stage II Lung Cancer
Stage III Lung Cancer
Stage IV Lung Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-04-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Patient 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 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 s elf-report receiving unpaid care from a caregiver who meets the study caregiver criteria and who is willing to participate

Caregiver Inclusion Criteria:

* Must be ≥18 years of age, as this study is focused on the experience of adult patient-caregiver dyads
* Must self-report providing the majority of the unpaid 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

Patient Exclusion Criteria:

* Post-treatment survivors 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

Caregiver Exclusion Criteria:

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

Primary outcomes:
measure: Caregiver retention at 12 weeks
timeFrame: At 12 weeks
Secondary outcomes:
measure: Caregiver accrual rate
timeFrame: Upon completion of recruitment, approximately 12 months
measure: Caregiver participation
timeFrame: Upon completion of recruitment, approximately 12 months
measure: Caregiver retention at 24 weeks
timeFrame: At 24 weeks
measure: Caregiver acceptability
timeFrame: At 12 weeks
measure: Average time (minutes) needed for training for Local Practice Referral Coordinator
timeFrame: At completion of training, up to 6 months
measure: Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator
timeFrame: At completion of training, up to 6 months
measure: Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database
timeFrame: At conclusion of practice intervention activities, an average of 18 months
measure: Frequency of needed resource updates in the CONNECT database
timeFrame: Up to completion of practice intervention activities, an average of 18 months
measure: Average time (minutes) spent by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
timeFrame: Up to completion of practice intervention activities, an average of 18 months
measure: Modality of contact (e.g. phone, virtual web meeting, email) made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
timeFrame: Up to completion of practice intervention activities, an average of 18 months
measure: Number of contacts made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
timeFrame: Up to completion of practice intervention activities, an average of 18 months
measure: Number of referrals facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator
timeFrame: Up to completion of practice intervention activities, an average of 18 months
measure: Type of referrals (e.g., in person, online) facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator
timeFrame: Up to completion of practice intervention activities, an average of 18 months
measure: Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator
timeFrame: Up to completion of practice intervention activities, an average of 18 months
measure: Modalities used for communication (e.g., phone, virtual web meeting, email) for Central Caregiver Navigator and Local Practice Referral Coordinator
timeFrame: Up to completion of practice intervention activities, an average of 18 months
measure: Improvements for the future trial from Local Practice Referral Coordinator's perspectives from a survey at the end of the study
timeFrame: At completion of practice intervention activities, an average of 18 months
Other outcomes:
measure: Patient accrual rate
timeFrame: Upon completion of recruitment, approximately 12 months
measure: Patient participation rate
timeFrame: Upon completion of recruitment, approximately 12 months
measure: Patient retention at 12 weeks
timeFrame: At 12 weeks
measure: Patient retention at 24 weeks
timeFrame: At 24 weeks
Locations:
city: Denver
country: United States
facility: Kaiser Permanente-Franklin
state: Colorado
city: Lafayette
country: United States
facility: Kaiser Permanente - Rock Creek
state: Colorado
city: Lone Tree
country: United States
facility: Kaiser Permanente - Lone Tree
state: Colorado
city: Millville
country: United States
facility: Beebe South Coastal Health Campus
state: Delaware
city: Rehoboth Beach
country: United States
facility: Beebe Health Campus
state: Delaware
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: 'Aiea
country: United States
facility: Hawaii Cancer Care - Westridge
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc - Waterfront Plaza
state: Hawaii
city: Osage Beach
country: United States
facility: Lake Regional Hospital
state: Missouri
city: Springfield
country: United States
facility: CoxHealth South Hospital
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center-Einstein Campus
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest NCORP Research Base
state: North Carolina
city: Scranton
country: United States
facility: Community Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley/Henry Cancer Center
state: Pennsylvania
city: Gaffney
country: United States
facility: Gibbs Cancer Center-Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Butternut
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Eastside
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Union
country: United States
facility: MGC Hematology Oncology-Union
state: South Carolina
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Kenosha
country: United States
facility: Aurora Cancer Care-Kenosha South
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Neenah
country: United States
facility: ThedaCare Regional Medical Center - Neenah
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathryn Weaver, PhD
role: STUDY_CHAIR
References: