Clinical trial NCT01885455: Improving Resection Rates Among African Americans With NSCLC
Official title: Improving Resection Rates Among African Americans With NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: non-small cell lung cancer (NSCLC)
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 248
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* AA race
* Clinically suspicious or biopsy-proven, early stage NSCLC, and
* Ages 21 years and older

Exclusion Criteria:

* Previous history of lung cancer
* Spread of newly diagnosed probably/proven lung cancer to other part of the body
* Diagnosis of synchronous cancer other than non-melanoma skin cancer or lung cancer, and
* Receipt of surgical resection or radiosurgery for lung cancer since diagnosis with probable/proven lung cancer

Primary outcomes:
measure: Receipt of LDTCI
timeFrame: 12 Months Post-Enrollment
Secondary outcomes:
measure: Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review
timeFrame: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
measure: Time to LDTCI (For Pts. Who Received LDTCI Only) Confirmed by Medical Record Review
timeFrame: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
measure: Satisfaction with Care Received, Patient Satisfaction(REF) (28 items)
timeFrame: 6 Months Post-Enrollment
measure: Time of Death, Follow-up Survey, Confirmed by Medical Record Review
timeFrame: Baseline, 3, 6, 9, and 12 Months Post-Enrollment
Other outcomes:
Locations:
city: Lewes
country: United States
facility: Beebe Healthcare Tunnell Cancer Center
state: Delaware
city: Savannah
country: United States
facility: Saint Joseph's/Candler Hospital
state: Georgia
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Ochsner NCORP
state: Louisiana
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
city: Saint Louis Park
country: United States
facility: Metro-Minnesota NCORP
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation
state: Nevada
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Fox Chase
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Wake Forest Universith Health Sciences
name: Kathryn E Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
References: