Improving Resection Rates Among African Americans With NSCLC

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

Improving Resection Rates Among African Americans With NSCLC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885455
• Other study ID #: IRB00031268
• Secondary ID: REBAWF 01414
• Status: Completed
• Phase: N/A
• Start date: April 23, 2015
• Est. completion date: September 9, 2019

Study information

• Verified date: March 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: September 9, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer (NSCLC)

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Beebe Healthcare Tunnell Cancer Center	Lewes	Delaware
United States	Ochsner NCORP	New Orleans	Louisiana
United States	Fox Chase	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Beaumont Hospital - Royal Oak	Royal Oak	Michigan
United States	Metro-Minnesota NCORP	Saint Louis Park	Minnesota
United States	Saint Joseph's/Candler Hospital	Savannah	Georgia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of LDTCI	Receipt of lung-directed therapy with curative intent (LDTCI), Inquiry at time of follow-up survey, confirmed by medical record review	12 Months Post-Enrollment
Secondary	Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review	• Receipt of surgical and/or radiation oncology consultation (defined as outpatient or inpatient consultation with a general or cardiothoracic surgeon and/or radiation oncologist to discuss LDTCI for NSCLC within 4 months post-diagnosis of probable/proven, early stage NSCLC).	Baseline, 3, 6, 9, and 12 Months Post-Enrollment
Secondary	Time to LDTCI (For Pts. Who Received LDTCI Only) Confirmed by Medical Record Review	Time to LDTCI (For Pts. Who Received LDTCI Only). Inquiry at Time of Follow-Up Survey, Confirmed by Medical Record Review. Baseline, 3, 6, 9, and 12 Months Post-Enrollment	Baseline, 3, 6, 9, and 12 Months Post-Enrollment
Secondary	Satisfaction with Care Received, Patient Satisfaction(REF) (28 items)	Satisfaction with Care Received, Patient Satisfaction(REF) (28 items). 6 Months Post-Enrollment	6 Months Post-Enrollment
Secondary	Time of Death, Follow-up Survey, Confirmed by Medical Record Review	Time of Death. Inquiry at Time of Follow-Up Survey, Confirmed by Medical Record Review , inquiry of cancer registries at study sites, and inquiry of Social Security Death Index. Baseline, 3, 6, 9, and 12 Months Post-Enrollment.	Baseline, 3, 6, 9, and 12 Months Post-Enrollment