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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
216
Receive a generic resource list
Receive personalized resource list
Receive access to CONNECT tool
Complete calls with caregiver navigator
Kaiser Permanente-Franklin
Denver, Colorado, United States
Kaiser Permanente - Rock Creek
Lafayette, Colorado, United States
Kaiser Permanente - Lone Tree
Lone Tree, Colorado, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Augusta University Medical Center
Augusta, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
Lake Regional Hospital
Osage Beach, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
...and 15 more locations
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.
Time frame: At 12 weeks
Caregiver accrual rate
Number of caregivers who agree to participate divided by the number of months of recruitment
Time frame: Upon completion of recruitment, approximately 12 months
Caregiver participation
Proportion of eligible caregivers who agreed to participate
Time frame: Upon completion of recruitment, approximately 12 months
Caregiver retention at 24 weeks
Number of caregivers who complete at least 75% of the 24-week assessments divided by the number randomized.
Time frame: At 24 weeks
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)
Time frame: At 12 weeks
Average time (minutes) needed for training for Local Practice Referral Coordinator
Will be summarized across practices using mean, median, standard deviation and interquartile range.
Time frame: At completion of training, up to 6 months
Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator
Will be summarized using appropriate descriptive statistics.
Time frame: At completion of training, up to 6 months
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.
Time frame: At conclusion of practice intervention activities, an average of 18 months
Frequency of needed resource updates in the CONNECT database
Will be summarized across practices using mean, median, standard deviation and interquartile range
Time frame: Up to completion of practice intervention activities, an average of 18 months
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.
Time frame: Up to completion of practice intervention activities, an average of 18 months
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.
Time frame: Up to completion of practice intervention activities, an average of 18 months
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.
Time frame: Up to completion of practice intervention activities, an average of 18 months
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.
Time frame: Up to completion of practice intervention activities, an average of 18 months
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.
Time frame: Up to completion of practice intervention activities, an average of 18 months
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.
Time frame: Up to completion of practice intervention activities, an average of 18 months
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.
Time frame: Up to completion of practice intervention activities, an average of 18 months
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.
Time frame: At completion of practice intervention activities, an average of 18 months
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