- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03919864
Recruitment Status Completed
First Posted April 18, 2019
Last update posted August 3, 2020
The purpose of this research study is to evaluate a technology-based intervention, Caregiver Oncology Needs Evaluation Tool (CONNECT), which may increase lung cancer caregivers' knowledge about the benefits of supportive care resources, identify their unmet needs, and connect them with supportive care resources. The investigators will also determine their ability to recruit and keep patients and caregivers in the study.
The long-term goal of this program of research is to improve supportive care delivery and lung cancer caregiver and patient well-being through a caregiver delivered intervention, Caregiver Oncology Needs Evaluation Tool (CONNECT). The investigators propose to evaluate a novel technology-based intervention, CONNECT, informed by theory with input from an advisory panel including a lung cancer caregiver and stakeholders. The purpose of CONNECT is to empower and educate caregivers about the benefits of supportive care resources and to systematically identify unmet needs and connect lung cancer caregivers with tailored supportive care resources. CONNECT is designed to be low cost and to capture the various resources offered in different oncology environments to support future adaptation and dissemination for heterogeneous healthcare settings.
|Other: CONNECT Intervention Group
CONNECT includes a multi-component e-tool with the following: (1) a brief educational video that seeks to empower and educate caregivers about the importance of self-care and benefits of supportive care resource use; (2) an assessment of multidimensional supportive care needs (e.g., psychological, behavioral, social, financial, educational, spiritual); (3) a tailored resource list that includes local and national resources corresponding to caregivers needs (Table1); and (4) an optional automated referral to a caregiver navigator to facilitate connection to resources.
Behavioral: CONNECT Intervention
Participants will be included in a multi-component e-tool with brief educational videos, an assessment of multidimensional supportive care needs, a tailored resource list and an optional automated referral to a caregiver navigator. Two weeks after baseline participants will receive re-education and an optional referral.
|Other: CONTROL Group
Control arm participants will receive a generic (i.e., not tailored) printed list of hospital, community, and national supportive care resources. Control participants will not receive the educational video, complete the E-tool Preference survey, or have an option for an automated referral to a caregiver navigator
Behavioral: CONTROL Group
Participants will receive a generic printed list of hospital, community, and national supportive care resources.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Caregivers must be providing some capacity of informal (unpaid) care for a patient
meeting patient eligibility criteria. If a patient unexpectedly becomes deceased
during the study period, caregivers will be allowed to continue participation in the
assigned study arm and complete study assessments if they wish to.
- Caregivers must be > 18 years of age, as this study is focused on the experience of
adult patient-caregiver dyads.
- Patients must have a current diagnosis of limited stage small cell or stage 1-4
nonsmall cell lung cancer.
- Patients must be currently receiving or planning to receive treatment for their cancer
at the time of enrollment. For patients receiving surgery, the eligibility timeframe
will include 6 weeks following the date of surgery to account for the acute recovery
- Patients must be ambulatory and up more than 50% of waking hours, as measured by an
ECOG Performance Status rating of level 0, 1, or 2.
- Patients must be > 18 years of age, as this study is focused on the experience of
adult patient-caregiver dyads.
- Patients must be receiving some capacity of informal care from a caregiver meeting the
above criteria. If the caregiver unexpectedly becomes deceased during the study
period, the patient will be un-enrolled from this study as we are evaluating a
caregiver-only delivered intervention.
• Caregivers cannot read/ communicate in English.
- Patients who are post-treatment survivors at the time of study enrollment. For
patients receiving surgery only, this includes the period beyond acute recovery (i.e.
≥ 7 weeks post-surgery).
- Caregivers cannot read/ communicate in English.
Eligibility to participate in the study is conditional on participation of both the
caregiver and patient.
United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center
Wake Forest University Health Sciences
Lung Cancer Research Foundation
Principal Investigator: Chandylen Nighingale, Ph.D Wake Forest University Health Sciences