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 : Completed
First Posted : June 25, 2013
Last Update Posted : May 12, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer (NSCLC)||Other: Usual Care Other: Intervention Arm||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|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|
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.
- 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
- 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).
- 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
- 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
- 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.
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.
|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- AA race
- Clinically suspicious or biopsy-proven, early stage NSCLC, and
- Ages 21 years and older
- 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
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
|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|
|New Orleans, Louisiana, United States, 70121|
|United States, Michigan|
|Beaumont Hospital - Royal Oak|
|Royal Oak, Michigan, United States, 48073|
|United States, Minnesota|
|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|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Kathryn E Weaver, PhD||Wake Forest Universith Health Sciences|
Documents provided by Wake Forest University Health Sciences:
|Responsible Party:||Wake Forest University Health Sciences|
|Other Study ID Numbers:||
REBAWF 01414 ( Other Identifier: NCI )
|First Posted:||June 25, 2013 Key Record Dates|
|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|
non-small cell lung cancer (NSCLC)
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases