Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    improving resection rates among african americans with nsclc
Previous Study | Return to List | Next Study

Improving Resection Rates Among African Americans With NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885455
Recruitment Status : Active, not recruiting
First Posted : June 25, 2013
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Layout table for study information
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
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885455


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Kathryn E Weaver, PhD Wake Forest Universith Health Sciences

Layout table for additonal 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    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for 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