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Stage II Lung CancerCONNECTNCT06383988

A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources

A study testing Support for Caregiver - Generic List, Support for Caregiver - Personalized List and Internet-Based Intervention - CONNECT in people with Stage II Lung Cancer and Stage III Lung Cancer, run by Wake Forest University Health Sciences at 25 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Support for Caregiver - Generic List, Support for Caregiver - Personalized List and Internet-Based Intervention - CONNECT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
25 sitesUnited States
Study dates
11 Nov 2024to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Patient Exclusion Criteria:

  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Kaiser Permanente - Rock Creek

    Lafayette, Colorado, 80026

  • Kaiser Permanente - Lone Tree

    Lone Tree, Colorado, 80124

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • ThedaCare Regional Medical Center - Neenah

    Neenah, Wisconsin, 54956

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • MGC Hematology Oncology-Union

    Union, South Carolina, 29379

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Wake Forest NCORP Research Base

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official 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.

Read the 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.

Being tested
Support for Caregiver - Generic List, Support for Caregiver - Personalized List, Internet-Based Intervention - CONNECT, Patient Navigation
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Support for Caregiver - Generic ListOther

    Receive a generic resource list

  • Support for Caregiver - Personalized ListOther

    Receive personalized resource list

  • Internet-Based Intervention - CONNECTOther

    Receive access to CONNECT tool

  • Patient NavigationBehavioural

    Also called Patient Navigator Program

    Complete calls with caregiver navigator

Study groups in NCT06383988
Study groupRoleWhat they receive
Group 1 (Standard care followed by generic resource list)Active comparatorCaregivers receive standard care and are then given a generic resource list at week 24.
Receives: Other: Support for Caregiver - Generic List
Group 2 (Generic resource list)Active comparatorCaregiver receive a generic resource list at the start of the study.
Receives: Other: Support for Caregiver - Generic List
Group 3 (CONNECT, personalized list, and navigation)ExperimentalCaregivers 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.
Receives: Other: Support for Caregiver - Personalized List; Other: Internet-Based Intervention - CONNECT; Behavioral: Patient Navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 12 weeks

Secondary outcomes (16)

  1. Caregiver accrual rate

    Number of caregivers who agree to participate divided by the number of months of recruitment

    Measured: Upon completion of recruitment, approximately 12 months

  2. Caregiver participation

    Proportion of eligible caregivers who agreed to participate

    Measured: Upon completion of recruitment, approximately 12 months

  3. Caregiver retention at 24 weeks

    Number of caregivers who complete at least 75% of the 24-week assessments divided by the number randomized.

    Measured: At 24 weeks

  4. 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)

    Measured: At 12 weeks

  5. Average time (minutes) needed for training for Local Practice Referral Coordinator

    Will be summarized across practices using mean, median, standard deviation and interquartile range.

    Measured: At completion of training, up to 6 months

  6. Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator

    Will be summarized using appropriate descriptive statistics.

    Measured: At completion of training, up to 6 months

  7. 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.

    Measured: At conclusion of practice intervention activities, an average of 18 months

  8. Frequency of needed resource updates in the CONNECT database

    Will be summarized across practices using mean, median, standard deviation and interquartile range

    Measured: Up to completion of practice intervention activities, an average of 18 months

  9. 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.

    Measured: Up to completion of practice intervention activities, an average of 18 months

  10. 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.

    Measured: Up to completion of practice intervention activities, an average of 18 months

  11. 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.

    Measured: Up to completion of practice intervention activities, an average of 18 months

  12. 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.

    Measured: Up to completion of practice intervention activities, an average of 18 months

  13. 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.

    Measured: Up to completion of practice intervention activities, an average of 18 months

  14. 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.

    Measured: Up to completion of practice intervention activities, an average of 18 months

  15. 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.

    Measured: Up to completion of practice intervention activities, an average of 18 months

  16. 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.

    Measured: At completion of practice intervention activities, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start11 Nov 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06383988
Sponsor's protocol ID
IRB00112187
Other IDs
NCI-2023-10870, Lead Organization Identifier
Acronym
CONNECT
Status last verified
Sep 2026
First submitted
15 Apr 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Nightingale CL, Snavely AC, Levine BJ, Turner JC, Farris MK, Tingen MS, Foust M, Graves K, Danai J, Price SN, Asad SS, 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 Sep;168:108387. doi: 10.1016/j.cct.2026.108387. Epub 2026 Jun 27.

    PubMed 42364728

Questions about this trial

What is this clinical trial studying?

A study testing Support for Caregiver - Generic List, Support for Caregiver - Personalized List and Internet-Based Intervention - CONNECT in people with Stage II Lung Cancer and Stage III Lung Cancer, run by Wake Forest University Health Sciences at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver retention at 12 weeks (time frame: At 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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