Stage IV Lung Cancer Clinical Trial
— CONNECTOfficial title:
Multi-Site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Wake Forest University Health Sciences | National Cancer Institute (NCI) |
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 |
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