NCT01885455

Improving Resection Rates Among African Americans With NSCLC

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, interventional trial in which the navigation is the intervention. Phase is not applicable. The study is a randomized trial to evaluate the impact of a nurse-led patient navigation intervention in improving rates of receipt of lung-directed therapy with curative intent (LDTCI) among African Americans with early stage lung cancer. Study sites are cluster-randomized to either the usual care study arm or the to the navigation intervention study arm. Randomization occurred at the level of the study site rather than at the level of individual participants. There are two arms.

Detailed description

The burden to participants will be minimized to enhance retention. Patients in the usual care arm receive the current "gold standard" of treatment. The patients in the intervention arm are assigned to a PN, who helps to reduce the barriers to care that could negatively impact the patients' receipt of LDTCI. The telephone-administered survey is administered to all study participants at baseline and at 3-, 6-, and 12-months post-enrollment. It takes approximately 30-40 minutes to administer. The telephone mode of survey administration was chosen to reduce the number of visits that would be required by each patient. Interviews are scheduled at the convenience of the study participants. To further reduce burden to the study participants, the interviewers offer breaks during the interview process. Patients in both arms undergo standard therapy visits. Patients in the navigation arm receive standard therapy visits plus the navigation intervention. Outside of the standard therapy visits, no additional clinic visits are required of the study participants. Once informed consent has been obtained and the informed consent document is received, the SSC/PN will communicate to the MUSC HCC study staff the participant's contact information and that the participant is ready for baseline survey administration. All the study surveys will be administered by trained MUSC HCC study staff via telephone. A survey answer guide will be provided to the participant either in-person or via mail prior to administration of the baseline survey.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
OTHER	Usual Care	Usual care includes: complete staging work-up (CT/PET scan and possible mediastinoscopy), surgical consultation with a general or cardiothoracic surgeon, cardiac clearance and/or pulmonary function testing (if deemed necessary by the evaluating surgeon), surgical resection (wedge resection, lobectomy, pneumonectomy, or radiosurgery, as indicated by the size and location of the tumor), and adjuvant therapy (radiotherapy and/or chemotherapy, as determined by the intraoperative findings and pathology results).
OTHER	Intervention Arm	The proposed Intervention (EPDPN) will be administered by the PNs at the intervention sites on an outpatient basis. Several defining, fundamental characteristics of the PNs will ensure consistency of the intervention delivery across the various study sites.

Timeline

• Start date: 2015-04-23
• Primary completion: 2019-08-23
• Completion: 2019-09-09
• First posted: 2013-06-25
• Last updated: 2020-05-12

Locations

10 sites across 1 country: United States