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OpenTrials
Completed

NCT Number: NCT01885455

Improving Resection Rates Among African Americans With NSCLC

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beebe Healthcare Tunnell Cancer Center, Lewes, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2013
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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