- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03862001
Lung Cancer Screening: A Multilevel Intervention (LungCARE)
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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California
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San Francisco, California, Stati Uniti, 94143
- University of California, San Francisco
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- age 55-80
- smoked at least 30 pack-years in lifetime
- if former smoker, quit smoking within the last 15 years
- English speaker
- no prior history of lung cancer
- did not have a lung cancer screening test within the last year
- PCP does not object to patient's participation
- have a scheduled visit at University of California, San Francisco (UCSF) internal medicine clinics.
Exclusion Criteria:
- speaking a language other than English
- has a history of lung cancer
- had a lung cancer screening test within the last year
- PCP objects to patient's participation.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: LungCARE Group
The intervention group will receive the LungCARE intervention
|
The LungCARE intervention involves patient and PCP components. The patient component consists of watching a short, educational video, answering questions about lung cancer screening preferences, and receiving a patient report and handout. The PCP component consists of receiving a similar report (physician report) prior to the patient visit. This report is based on the patient's risk factors and lung cancer screening preferences. It contains additional information about documenting discussions related to risk, screening, and referrals in the electronic medical record system. |
Nessun intervento: Comparison Group
The comparison group will receive usual care.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Discussion of lung cancer risk and LDCT screening with PCP
Lasso di tempo: Over 3 months
|
Outcome 1 will be assessed in the follow-up survey, administered within one week following the clinic visit. All patients will answer the following yes/no questions: "During your PCP visit, did you discuss...your personal risk of getting lung cancer/the risks and benefits of screening/how often people should be screened/whether you should be screened?", "Did you discuss smoking cigarettes?", "Did you talk about smoking and the risk of lung cancer?", and "Did your doctor refer you to or order a test for lung cancer screening?" Each question will be looked at individually and summed into a single score (0-7). Higher scores indicate an increased discussion of lung cancer risk and LDCT screening. Three months following the clinic visit, the investigators will review the electronic health records for all patients who signed HIPAA forms. Investigators will gather information about discussion of lung cancer risk and documentation, referrals, counseling, and receipt of LDCT screening. |
Over 3 months
|
Knowledge of lung cancer screening
Lasso di tempo: Over one week
|
Outcome 2 will be assessed in the follow-up survey, administered within one week following the clinic visit.
All patients will answer true/false questions addressing various screening topics (e.g. annual lung cancer screening, false negative scans, false positive scans, who should be screened, and radiation exposure).
Correct answers will be given a score of 1 and incorrect answers will be given a score of 0. Responses for each question will be added up to a single score, ranging between 0 and 10.
Lower scores indicate lower knowledge and higher scores indicate higher knowledge.
|
Over one week
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Perception of lung cancer risk
Lasso di tempo: Over one week
|
Outcome 3 will be measured using an adapted Lerman Cancer Worry Scale.
The following question will be asked over the course of one week, both prior to and following the clinic visit: "In your opinion, compared to most people of your same age, sex, and race, what are you chances of getting lung cancer someday?" Participants will use a five-point Likert scale ("much higher" [1], "higher" [2], "about the same" [3], "lower" [4], "much lower" [5]) to answer the questions.
A higher score indicates a lower perception of lung cancer risk.
Responses will be compared between the baseline and follow-up surveys.
|
Over one week
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Worry about lung cancer
Lasso di tempo: Over one week
|
Outcome 4 will be measured using an adapted Lerman Cancer Worry Scale.
The following questions will be asked over the course of one week, both prior to and following the clinic visit: "How worried are you about getting lung cancer someday?", "During the past month, how much has your worry about lung cancer affected your mood?", "During the past month, how much has your worry about lung cancer affected your ability to perform your daily activities?", and "During the past month, how often have you thought about your chances of getting lung cancer?"
Patients will use a 5-point Likert scale ("a lot" [1], "somewhat" [2], "a little" [3], "not at all" [4]) to answer the first 3 questions and a 4-point Likert scale ("almost all the time" [1], "often" [2], "sometimes" [3], "not at all or rarely" [4]) to answer the last question.
Higher scores indicate a lower perception of risk.
Each question will be examined individually.
Responses will be compared between the baseline and follow-up surveys.
|
Over one week
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Celia Kaplan, DrPH, University of California, San Francisco
Pubblicazioni e link utili
Pubblicazioni generali
- Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.
- Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521. Erratum In: JAMA. 2012 Oct 3;308(13):1324. JAMA. 2013 Jun 5;309(21):2212.
- McBride CM, Emmons KM, Lipkus IM. Understanding the potential of teachable moments: the case of smoking cessation. Health Educ Res. 2003 Apr;18(2):156-70. doi: 10.1093/her/18.2.156.
- National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997 Mar;44(5):681-92. doi: 10.1016/s0277-9536(96)00221-3.
- Henderson S, DeGroff A, Richards TB, Kish-Doto J, Soloe C, Heminger C, Rohan E. A qualitative analysis of lung cancer screening practices by primary care physicians. J Community Health. 2011 Dec;36(6):949-56. doi: 10.1007/s10900-011-9394-2.
- Poghosyan H, Kennedy Sheldon L, Cooley ME. The impact of computed tomography screening for lung cancer on smoking behaviors: a teachable moment? Cancer Nurs. 2012 Nov-Dec;35(6):446-75. doi: 10.1097/NCC.0b013e3182406297.
Collegamenti utili
- U.S. Preventive Services Task Force. USPTF Bulletin: U.S. Preventive Services Task Force Issues Draft Recommendation Statement on Screening for Lung Cancer. U.S. Preventive Services Task Force 2013.
- Center for Medicare and Medicaid Services. Decision memo for screening for lung cancer with low dose computed tomography (LDCT).
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 17-22564
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