Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-10870 | Other Identifier | NCI Trial Identifier | |
| Lead Organization Identifier | Other Identifier | WF-2301CD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
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:
Caregiver Participants (Group 1, 2 and 3) will be asked to complete study surveys at three time points:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Standard care followed by generic resource list) | Active Comparator | Caregivers receive standard care and are then given a generic resource list at week 24. |
|
| Group 2 (Generic resource list) | Active Comparator | Caregiver receive a generic resource list at the start of the study. |
|
| Group 3 (CONNECT, personalized list, and navigation) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Support for Caregiver - Generic List | Other | Receive a generic resource list |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Caregiver participation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient participation rate | Proportion of eligible patients who agreed to participate |
Patient Inclusion Criteria:
Caregiver Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathryn Weaver, PhD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente-Franklin | Denver | Colorado | 80205 | United States | ||
| Kaiser Permanente - Rock Creek |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42364728 | Derived | Nightingale CL, Snavely AC, Levine B, Turner JC, Farris ML, Tingen MS, Foust M, Graves K, Danai J, Price SN, Asad S, Adonizio CS, Lesser GJ, Childrey L, Weaver KE. Multi-site feasibility of a web-based and telephone navigation intervention to connect lung cancer caregivers in community oncology settings with resources: Protocol for the WF-2301CD caregiver oncology needs evaluation tool (CONNECT) trial. Contemp Clin Trials. 2026 Jun 27:108387. doi: 10.1016/j.cct.2026.108387. Online ahead of print. |
Not provided
Not provided
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Not provided
6 months after publication for a 2 year duration
upon request to NCORP@wakehealth.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Support for Caregiver - Personalized List | Other | Receive personalized resource list |
|
| Internet-Based Intervention - CONNECT | Other | Receive access to CONNECT tool |
|
| Patient Navigation | Behavioral | Complete calls with caregiver navigator |
|
|
Proportion of eligible caregivers who agreed to participate
| 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. | 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) | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At completion of practice intervention activities, an average of 18 months |
| Upon completion of recruitment, approximately 12 months |
| 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 |
| 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 |
| Lafayette |
| Colorado |
| 80026 |
| United States |
| Kaiser Permanente - Lone Tree | Lone Tree | Colorado | 80124 | United States |
| Beebe South Coastal Health Campus | Millville | Delaware | 19967 | United States |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | United States |
| Hawaii Cancer Care - Westridge | ‘Aiea | Hawaii | 96701 | United States |
| Lake Regional Hospital | Osage Beach | Missouri | 65065 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| Wake Forest NCORP Research Base | Winston-Salem | North Carolina | 27157 | United States |
| Community Medical Center | Scranton | Pennsylvania | 18510 | United States |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | 29341 | United States |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| MGC Hematology Oncology-Union | Union | South Carolina | 29379 | United States |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States |
| Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | 53142 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| ThedaCare Regional Medical Center - Neenah | Neenah | Wisconsin | 54956 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided