Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383988
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-25
First Post:
2024-04-15
Brief Title:
A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Multi-Site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONNECT
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 ie lung cancer caregivers n120 and their care-recipients n120 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 111 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 ie 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 dont 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 dont have to answer any question that makes you feel uncomfortable
Participants ie 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 dont 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 dont have to answer any question that makes you feel uncomfortable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Lead Organization Identifier | OTHER | WF-2301CD | None |
| NCI-2023-10870 | OTHER | None | None |