Multi-Site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
- 试验地点
- 48
- 主要终点
- Caregiver retention at 12 weeks
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 (i.e., initial diagnosis) 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 self-report receiving informal (i.e., not professional) 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 informal (i.e. not professional) 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
排除标准
- •Patients who have completed treatment for their lung cancer 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
研究组 & 干预措施
Group 1 (Standard care followed by generic resource list)
Caregivers receive standard care and are then given a generic resource list at week 24.
干预措施: Support for Caregiver - Generic List (Other)
Group 2 (Generic resource list)
Caregiver receive a generic resource list at the start of the study.
干预措施: Support for Caregiver - Generic List (Other)
Group 3 (CONNECT, personalized list, and navigation)
Caregivers receive access to the CONNECT tool, watch an educational video on self care and receive a personalized list of resources based on caregiver preferences. Caregivers also receive access to and complete at least 2 calls, at baseline and at week 4, with a caregiver navigator to review the resource list and address any additional needs.
干预措施: Support for Caregiver - Personalized List (Other)
Group 3 (CONNECT, personalized list, and navigation)
Caregivers receive access to the CONNECT tool, watch an educational video on self care and receive a personalized list of resources based on caregiver preferences. Caregivers also receive access to and complete at least 2 calls, at baseline and at week 4, with a caregiver navigator to review the resource list and address any additional needs.
干预措施: Internet-Based Intervention - CONNECT (Other)
Group 3 (CONNECT, personalized list, and navigation)
Caregivers receive access to the CONNECT tool, watch an educational video on self care and receive a personalized list of resources based on caregiver preferences. Caregivers also receive access to and complete at least 2 calls, at baseline and at week 4, with a caregiver navigator to review the resource list and address any additional needs.
干预措施: Patient Navigation (Behavioral)
结局指标
主要结局
Caregiver retention at 12 weeks
时间窗: 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.
次要结局
- Caregiver participation(Upon completion of recruitment, approximately 12 months)
- Caregiver accrual rate(Upon completion of recruitment, approximately 12 months)
- Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator(At completion of training, up to 6 months)
- Frequency of needed resource updates in the CONNECT database(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(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(Up to completion of practice intervention activities, an average of 18 months)
- Caregiver retention at 24 weeks(At 24 weeks)
- Caregiver acceptability(At 12 weeks)
- 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(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(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(At completion of practice intervention activities, an average of 18 months)
- Average time (minutes) needed for training for Local Practice Referral Coordinator(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(At conclusion 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(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(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(Up to completion of practice intervention activities, an average of 18 months)