Trial Information

Improving Resection Rates Among African Americans With NSCLC

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.

Usual Care Arm: Participants who are assigned to the usual care arm may receive the
following services: 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). Participants will be
contacted at baseline and at 3-month intervals to complete telephone-administered study
surveys for one year.

Intervention Arm: Participants who are assigned to the intervention arm will receive a copy
of the NCI's "What You Need to Know about Lung Cancer" booklet and they will be assigned to
an RN-level nurse navigator. The patient navigators will contact their assigned participants
on at least a weekly basis. The role of the patient navigators is to: (1) help patients who
are newly diagnosed with early stage lung cancer schedule clinical appointments ; (2)
identify each patient's unique logistical and emotional needs (barriers to care) and
coordinate with professional staff to develop effective solutions; (3) connect patients to
community and social support services; (4) provide medical appointment reminders; (5)
accompany patients to their clinic appointments as requested; (6) reschedule appointments
when patients cannot keep them; (7) provide patients with sources of expert information
about the recommended surgical treatment; (8) guide patients through the health care system,
including helping them arrive at appointments on time and prepared; (9) interact with
patients to help them resolve financial, language, transportation, or other barriers to
treatment; (10) assist patients in finding ways to pay for their health care by working with
financial counselors at the health care site; (11) organize and coordinate patient
transportation services; (12) provide health education to patients about lung cancer surgery
and other relevant information (this may include smoking cessation services); (13) help
patients to access language-specific materials, (14) facilitate interaction and
communication with health care staff and providers; (15) use lay language to describe the
medical terms used by clinicians, and explain patients' concerns to their health care
providers so that these concerns can be addressed; (16) interact with patients' specialists
to relay patients' concerns about surgical resection so that they can be addressed by these
specialists; (17) provide support through active, empathic listening; (18) arrange for
patients to hear "testimonials" from other patients with similar racial and ethnic
backgrounds who had successful surgical outcomes for treatment of NSCLC and (19) respect
patients' medical treatment decisions.

The patient navigation intervention is standardized to ensure consistency of the
intervention delivery across the three intervention study sites. The navigators employ a
secure, web-based data management system to track the frequency, intensity, and content of
the navigation intervention. Information that is recorded includes the number, length, and
type of contact (telephone, email or in person) with each participant, and a description of
the barriers that were addressed. This system fosters the successful deployment of the
intervention in a standardized manner across the intervention sites and it identifies the
specific types of barriers to surgery or radiosurgery that were overcome through the
navigation intervention. These data will also be used to estimate the cost (using
time-driven, activity-based costing) and cost-effectiveness (increase in quality-adjusted
life years/cost) of the navigation intervention in a subsequent study. To further ensure
treatment fidelity, in Year the navigators participated in a 24- hour patient navigation
training program led by the study consultant, Dr. Beth Calhoun, who is one of the nation's
leading patient navigation experts, and Dr. Debbie C. Bryant, who led a successful breast
cancer-focused patient navigation intervention at the Medical University of South Carolina
MUSC Hollings Cancer Center (MUSC HCC). In addition, the navigators participate in bi-weekly
teleconferences led by Dr. Ford, during which the intervention is discussed in detail and
training is provided in such areas as developing effective communication approaches,
identifying institutional and community resources, and problem-solving.