Trial Title:
A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources
NCT ID:
NCT06383988
Condition:
Stage II Lung Cancer
Stage III Lung Cancer
Stage IV Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Support for Caregiver - Generic List
Description:
Receive a generic resource list
Arm group label:
Group 1 (Standard care followed by generic resource list)
Arm group label:
Group 2 (Generic resource list)
Intervention type:
Other
Intervention name:
Support for Caregiver - Personalized List
Description:
Receive personalized resource list
Arm group label:
Group 3 (CONNECT, personalized list, and navigation)
Intervention type:
Other
Intervention name:
Internet-Based Intervention - CONNECT
Description:
Receive access to CONNECT tool
Arm group label:
Group 3 (CONNECT, personalized list, and navigation)
Intervention type:
Behavioral
Intervention name:
Patient Navigation
Description:
Complete calls with caregiver navigator
Arm group label:
Group 3 (CONNECT, personalized list, and navigation)
Other name:
Patient Navigator Program
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 (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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Kaiser Permanente-Franklin
Address:
City:
Denver
Zip:
80205
Country:
United States
Facility:
Name:
Kaiser Permanente - Rock Creek
Address:
City:
Lafayette
Zip:
80026
Country:
United States
Facility:
Name:
Kaiser Permanente - Lone Tree
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Facility:
Name:
Augusta University Medical Center
Address:
City:
Augusta
Zip:
30912
Country:
United States
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Address:
City:
Columbus
Zip:
39705
Country:
United States
Facility:
Name:
Baptist Cancer Center-Grenada
Address:
City:
Grenada
Zip:
38901
Country:
United States
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Union County
Address:
City:
New Albany
Zip:
38652
Country:
United States
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Oxford
Address:
City:
Oxford
Zip:
38655
Country:
United States
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Desoto
Address:
City:
Southhaven
Zip:
38671
Country:
United States
Facility:
Name:
Lake Regional Hospital
Address:
City:
Osage Beach
Zip:
65065
Country:
United States
Facility:
Name:
CoxHealth South Hospital
Address:
City:
Springfield
Zip:
65807
Country:
United States
Facility:
Name:
Montefiore Medical Center-Einstein Campus
Address:
City:
Bronx
Zip:
10461
Country:
United States
Facility:
Name:
Wake Forest NCORP Research Base
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Facility:
Name:
Community Medical Center
Address:
City:
Scranton
Zip:
18510
Country:
United States
Facility:
Name:
Geisinger Wyoming Valley/Henry Cancer Center
Address:
City:
Wilkes-Barre
Zip:
18711
Country:
United States
Facility:
Name:
Gibbs Cancer Center-Gaffney
Address:
City:
Gaffney
Zip:
29341
Country:
United States
Facility:
Name:
Prisma Health Cancer Institute - Butternut
Address:
City:
Greenville
Zip:
29605
Country:
United States
Facility:
Name:
Prisma Health Cancer Institute - Eastside
Address:
City:
Greenville
Zip:
29615
Country:
United States
Facility:
Name:
Gibbs Cancer Center-Pelham
Address:
City:
Greer
Zip:
29651
Country:
United States
Facility:
Name:
Spartanburg Medical Center
Address:
City:
Spartanburg
Zip:
29303
Country:
United States
Facility:
Name:
MGC Hematology Oncology-Union
Address:
City:
Union
Zip:
29379
Country:
United States
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Collierville
Address:
City:
Collierville
Zip:
38017
Country:
United States
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Memphis
Address:
City:
Memphis
Zip:
38120
Country:
United States
Facility:
Name:
ThedaCare Regional Cancer Center
Address:
City:
Appleton
Zip:
54911
Country:
United States
Start date:
November 11, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383988
