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.
Brief Title
A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Stage II Lung Cancer
Stage III Lung Cancer
Stage IV Lung Cancer
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06383988
Org Class
Other
Org Full Name
Wake Forest University Health Sciences
Org Study Id
IRB00112187
Overall Status
Enrolling by invitation
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Multi-Site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers
Primary Outcomes
Outcome Description
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.
Outcome Measure
Caregiver retention at 12 weeks
Outcome Time Frame
At 12 weeks
Secondary Ids
Secondary Id
NCI-2023-10870
Secondary Id
Lead Organization Identifier
Secondary Outcomes
Outcome Description
Number of caregivers who agree to participate divided by the number of months of recruitment
Outcome Time Frame
Upon completion of recruitment, approximately 12 months
Outcome Measure
Caregiver accrual rate
Outcome Description
Proportion of eligible caregivers who agreed to participate
Outcome Time Frame
Upon completion of recruitment, approximately 12 months
Outcome Measure
Caregiver participation
Outcome Description
Number of caregivers who complete at least 75% of the 24-week assessments divided by the number randomized.
Outcome Time Frame
At 24 weeks
Outcome Measure
Caregiver retention at 24 weeks
Outcome Description
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)
Outcome Time Frame
At 12 weeks
Outcome Measure
Caregiver acceptability
Outcome Description
Will be summarized across practices using mean, median, standard deviation and interquartile range.
Outcome Time Frame
At completion of training, up to 6 months
Outcome Measure
Average time (minutes) needed for training for Local Practice Referral Coordinator
Outcome Description
Will be summarized using appropriate descriptive statistics.
Outcome Time Frame
At completion of training, up to 6 months
Outcome Measure
Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator
Outcome Description
Will be summarized across practices using mean, median, standard deviation and interquartile range.
Outcome Time Frame
At conclusion of practice intervention activities, an average of 18 months
Outcome Measure
Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database
Outcome Description
Will be summarized across practices using mean, median, standard deviation and interquartile range
Outcome Time Frame
Up to completion of practice intervention activities, an average of 18 months
Outcome Measure
Frequency of needed resource updates in the CONNECT database
Outcome Description
Will be summarized across practices using mean, median, standard deviation and interquartile range.
Outcome Time Frame
Up to completion of practice intervention activities, an average of 18 months
Outcome Measure
Average time (minutes) spent by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
Outcome Description
Will be summarized using appropriate descriptive statistics.
Outcome Time Frame
Up to completion of practice intervention activities, an average of 18 months
Outcome 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
Outcome Description
Will be summarized across practices using mean, median, standard deviation and interquartile range.
Outcome Time Frame
Up to completion of practice intervention activities, an average of 18 months
Outcome Measure
Number of contacts made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
Outcome Description
Will be summarized across practices using mean, median, standard deviation and interquartile range.
Outcome Time Frame
Up to completion of practice intervention activities, an average of 18 months
Outcome Measure
Number of referrals facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator
Outcome Description
Will be summarized using appropriate descriptive statistics.
Outcome Time Frame
Up to completion of practice intervention activities, an average of 18 months
Outcome Measure
Type of referrals (e.g., in person, online) facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator
Outcome Description
Will be summarized across practices using mean, median, standard deviation and interquartile range.
Outcome Time Frame
Up to completion of practice intervention activities, an average of 18 months
Outcome Measure
Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator
Outcome Description
Will be summarized using appropriate descriptive statistics.
Outcome Time Frame
Up to completion of practice intervention activities, an average of 18 months
Outcome Measure
Modalities used for communication (e.g., phone, virtual web meeting, email) for Central Caregiver Navigator and Local Practice Referral Coordinator
Outcome Description
Will be summarized using appropriate descriptive statistics.
Outcome Time Frame
At completion of practice intervention activities, an average of 18 months
Outcome Measure
Improvements for the future trial from Local Practice Referral Coordinator's perspectives from a survey at the end of the study
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org