Improving Resection Rates Among African Americans With NSCLC

• ClinicalTrials.gov Identifier: NCT01885455
• Recruitment Status: Completed
• First Posted: June 25, 2013
• Last Update Posted: May 12, 2020
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer (NSCLC)	Other: Usual Care; Other: Intervention Arm	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 248 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Resection Rates Among African Americans With NSCLC
• Actual Study Start Date: April 23, 2015
• Actual Primary Completion Date: August 23, 2019
• Actual Study Completion Date: September 9, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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).	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).
Experimental: Intervention Arm; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Receipt of LDTCI [ Time Frame: 12 Months Post-Enrollment ]
   Receipt of lung-directed therapy with curative intent (LDTCI), Inquiry at time of follow-up survey, confirmed by medical record review

Secondary Outcome Measures :

1. Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review [ Time Frame: Baseline, 3, 6, 9, and 12 Months Post-Enrollment ]
   • 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).
2. Time to LDTCI (For Pts. Who Received LDTCI Only) Confirmed by Medical Record Review [ Time Frame: Baseline, 3, 6, 9, and 12 Months Post-Enrollment ]
   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
3. Satisfaction with Care Received, Patient Satisfaction(REF) (28 items) [ Time Frame: 6 Months Post-Enrollment ]
   Satisfaction with Care Received, Patient Satisfaction(REF) (28 items). 6 Months Post-Enrollment
4. Time of Death, Follow-up Survey, Confirmed by Medical Record Review [ Time Frame: Baseline, 3, 6, 9, and 12 Months Post-Enrollment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Delaware

Beebe Healthcare Tunnell Cancer Center

Lewes, Delaware, United States, 19958

United States, Georgia

Saint Joseph's/Candler Hospital

Savannah, Georgia, United States, 31405

United States, Illinois

Stroger Hospital of Cook County

Chicago, Illinois, United States, 60612

United States, Louisiana

Ochsner NCORP

New Orleans, Louisiana, United States, 70121

United States, Michigan

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States, 48073

United States, Minnesota

Metro-Minnesota NCORP

Saint Louis Park, Minnesota, United States, 55426

United States, Nevada

Nevada Cancer Research Foundation

Las Vegas, Nevada, United States, 89106

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27127

United States, Pennsylvania

Fox Chase

Philadelphia, Pennsylvania, United States, 19111

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Kathryn E Weaver, PhD; Wake Forest Universith Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Informed Consent Form  [PDF] July 1, 2018

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01885455
• Other Study ID Numbers: IRB00031268; REBAWF 01414 ( Other Identifier: NCI )
• First Posted: June 25, 2013
• Last Update Posted: May 12, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

non-small cell lung cancer (NSCLC)

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms