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

Stage IV Lung Cancer Clinical Trial

— CONNECT  

Official title:

Multi-Site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383988
• Other study ID #: IRB000112187
• Secondary ID: NCI-2023-10870Le
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Karen Craver
• Phone: 336-716-0891
• Email: NCORP[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (gender, 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 (gender, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Eastern Cooperative Oncology Group (ECOG) performance status rating of level 0, 1, or 2

• Must be 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 be 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 a 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 communicate in English

Caregiver Exclusion Criteria:

• Currently receiving cancer treatment

• No access to a telephone

• Unable to read and communicate in English, as the CONNECT intervention is currently only available in English

Related Conditions & MeSH terms

• Lung Neoplasms
• Stage II Lung Cancer
• Stage III Lung Cancer
• Stage IV Lung Cancer

Intervention

Other:
• Support for Caregiver - Generic List
Receive a generic resource list
• Support for Caregiver - Personalized List
Receive personalized resource list
• Internet-Based Intervention - CONNECT
Receive access to CONNECT tool

Behavioral:
• Patient Navigation
Complete calls with caregiver navigator

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient accrual rate	Number of patients who agree to participate divided by the number of months of recruitment	Upon completion of recruitment, approximately 12 months
Other	Patient participation rate	Proportion of eligible patients who agreed to participate	Upon completion of recruitment, approximately 12 months
Other	Patient retention at 12 weeks	Number of patients who complete at least 75% of the 12-week assessments divided by the number randomized	At 12 weeks
Other	Patient retention at 24 weeks	Number of patients who complete at least 75% of the 24-week assessments divided by the number randomized	At 24 weeks
Primary	Caregiver retention at 12 weeks	Calculated as the following: Number of caregivers who complete at least 75% of the 12-week assessments divided by the number randomized. Retention will be estimated and reported along with an exact 95% confidence interval.	At 12 weeks
Secondary	Caregiver accrual rate	Number of caregivers who agree to participate divided by the number of months of recruitment	Upon completion of recruitment, approximately 12 months
Secondary	Caregiver participation	Proportion of eligible caregivers who agreed to participate	Upon completion of recruitment, approximately 12 months
Secondary	Caregiver retention at 24 weeks	Number of caregivers who complete at least 75% of the 24-week assessments divided by the number randomized.	At 24 weeks
Secondary	Caregiver acceptability	Self-report survey developed for this study to assess the degree to which caregivers found different aspects of CONNECT, the generic resource list, or usual care helpful using a Likert response from 0 (Not at all) to 5 (Very Much)	At 12 weeks
Secondary	Average time (minutes) needed for training for Local Practice Referral Coordinator	Will be summarized across practices using mean, median, standard deviation and interquartile range.	At completion of training, up to 6 months
Secondary	Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator	Will be summarized using appropriate descriptive statistics.	At completion of training, up to 6 months
Secondary	Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database	Will be summarized across practices using mean, median, standard deviation and interquartile range.	At conclusion of practice intervention activities, an average of 18 months
Secondary	Frequency of needed resource updates in the CONNECT database	Will be summarized across practices using mean, median, standard deviation and interquartile range	Up to completion of practice intervention activities, an average of 18 months
Secondary	Average time (minutes) spent by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm	Will be summarized across practices using mean, median, standard deviation and interquartile range.	Up to completion of practice intervention activities, an average of 18 months
Secondary	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	Will be summarized using appropriate descriptive statistics.	Up to completion of practice intervention activities, an average of 18 months
Secondary	Number of contacts made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm	Will be summarized across practices using mean, median, standard deviation and interquartile range.	Up to completion of practice intervention activities, an average of 18 months
Secondary	Number of referrals facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator	Will be summarized across practices using mean, median, standard deviation and interquartile range.	Up to completion of practice intervention activities, an average of 18 months
Secondary	Type of referrals (e.g., in person, online) facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator	Will be summarized using appropriate descriptive statistics.	Up to completion of practice intervention activities, an average of 18 months
Secondary	Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator	Will be summarized across practices using mean, median, standard deviation and interquartile range.	Up to completion of practice intervention activities, an average of 18 months
Secondary	Modalities used for communication (e.g., phone, virtual web meeting, email) for Central Caregiver Navigator and Local Practice Referral Coordinator	Will be summarized using appropriate descriptive statistics.	Up to completion of practice intervention activities, an average of 18 months
Secondary	Improvements for the future trial from Local Practice Referral Coordinator's perspectives from a survey at the end of the study	Will be summarized using appropriate descriptive statistics.	At completion of practice intervention activities, an average of 18 months