Improving Resection Rates Among African Americans With NSCLC

NCT01885455 | Completed DMC

• 2 other identifiers: IRB00031268REBAWF 01414
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 10

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review

  Baseline, 3, 6, 9, and 12 Months Post-Enrollment

• Time to LDTCI (For Pts. Who Received LDTCI Only) Confirmed by Medical Record Review

  Baseline, 3, 6, 9, and 12 Months Post-Enrollment

• Satisfaction with Care Received, Patient Satisfaction(REF) (28 items)

  6 Months Post-Enrollment

• Time of Death, Follow-up Survey, Confirmed by Medical Record Review

  Baseline, 3, 6, 9, and 12 Months Post-Enrollment

Study Arms (2)

Usual Care Arm

ACTIVE COMPARATOR

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).

Other: Usual Care

Intervention Arm

EXPERIMENTAL

The PN will provide each patient with a copy of the NCI's "What You Need to Know About Lung Cancer" booklet and encourage them to re-contact his/her primary care physician (or the physician who diagnosed their probable/proven NSCLC) to discuss treatment options. The PNs will provide patients with their contact information and brief patients on their role. The PNs will navigate study participants for up to 4 months (16 weeks, 112 days) after NSCLC diagnosis, until the patient is deemed ineligible for LDTCI (i.e., lung resection or SBRT) by their physician(s), until receipt of LDTCI, or death (whichever comes first). During the EPDPN intervention period, PNs will contact each intervention group participant by telephone (or in-person) on weekly basis (at minimum).

Other: Intervention Arm

Interventions

Usual Care OTHER

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).

Usual Care Arm

Intervention Arm OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (10)

Beebe Healthcare Tunnell Cancer Center

Lewes, Delaware, 19958, United States

Location

Saint Joseph's/Candler Hospital

Savannah, Georgia, 31405, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Ochsner NCORP

New Orleans, Louisiana, 70121, United States

Location

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Metro-Minnesota NCORP

Saint Louis Park, Minnesota, 55426, United States

Location

Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27127, United States

Location

Fox Chase

Philadelphia, Pennsylvania, 19111, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kathryn E Weaver, PhD

  Wake Forest Universith Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 25, 2013
• Study Start: April 23, 2015
• Primary Completion: August 23, 2019
• Study Completion: September 9, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)