Improving Resection Rates Among African Americans With NSCLC
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Delaware
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Lewes、Delaware、アメリカ、19958
- Beebe Healthcare Tunnell Cancer Center
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Georgia
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Savannah、Georgia、アメリカ、31405
- Saint Joseph's/Candler Hospital
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Illinois
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Chicago、Illinois、アメリカ、60612
- Stroger Hospital of Cook County
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Louisiana
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New Orleans、Louisiana、アメリカ、70121
- Ochsner NCORP
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Michigan
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Royal Oak、Michigan、アメリカ、48073
- Beaumont Hospital - Royal Oak
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Minnesota
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Saint Louis Park、Minnesota、アメリカ、55426
- Metro-Minnesota NCORP
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Nevada
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Las Vegas、Nevada、アメリカ、89106
- Nevada Cancer Research Foundation
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27127
- Wake Forest University Health Sciences
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19111
- Fox Chase
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Virginia
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ: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).
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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).
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実験的: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). |
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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Receipt of LDTCI
時間枠:12 Months Post-Enrollment
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Receipt of lung-directed therapy with curative intent (LDTCI), Inquiry at time of follow-up survey, confirmed by medical record review
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12 Months Post-Enrollment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review
時間枠:Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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• 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).
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Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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Time to LDTCI (For Pts. Who Received LDTCI Only) Confirmed by Medical Record Review
時間枠:Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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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
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Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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Satisfaction with Care Received, Patient Satisfaction(REF) (28 items)
時間枠:6 Months Post-Enrollment
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Satisfaction with Care Received, Patient Satisfaction(REF) (28 items).
6 Months Post-Enrollment
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6 Months Post-Enrollment
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Time of Death, Follow-up Survey, Confirmed by Medical Record Review
時間枠:Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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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.
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Baseline, 3, 6, 9, and 12 Months Post-Enrollment
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協力者と研究者
捜査官
- 主任研究者:Kathryn E Weaver, PhD、Wake Forest Universith Health Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Usual Careの臨床試験
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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New York UniversitySt. Luke's-Roosevelt Hospital Center完了
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New York UniversityIndiana University; Moi University完了
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Boston Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD); Center for Community Health...完了肥満 | 喘息 | 血圧 | 小児発達 | ヘルスケアの利用 | 児童虐待 | 医療格差 | 満たされていない基本的な社会的ニーズアメリカ
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Fondation Oeuvre de la Croix Saint-Simon引きこもった
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University Health Network, Toronto募集リンパ腫 | リンパ増殖性疾患 | 乳がんステージ I | 乳がんステージ II | 大腸がんステージ II | 結腸直腸がん III期 | 乳がんステージ III | 結腸直腸がんステージ I | 頭頸部がん III期 | 乳がん、ステージ0 | 頭頸部がんステージ I | 頭頸部がんステージ IIカナダ
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Emory UniversityFoundation for Physical Therapy, Inc.完了
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Saint-Joseph University完了