Improving Resection Rates Among African Americans With NSCLC
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/14/2018 |
| Start Date: | April 23, 2015 |
| End Date: | February 2020 |
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.
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.
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.
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.
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
We found this trial at
10
sites
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18947 John J Williams Highway
Lewes, Delaware 19958
Lewes, Delaware 19958
Phone: 302-645-3100
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Phone: 336-713-6519
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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