Lung Cancer Screening Navigation for Homeless People

Vetëm përdoruesit e regjistruar mund të përkthejnë artikuj

Identifikohuni Regjistrohu

Lidhja ruhet në kujtesën e fragmenteve

StatusiNuk është ende rekrutimi

Sponsorët

Massachusetts General Hospital

Bashkëpunëtorë

American Cancer Society, Inc.

TRAJTIM KLINIKAL: NCT04308226

BioSeek: nct04308226

Fjalë kyçe

Abstrakt

We will conduct a pragmatic clinical trial to test the effect of patient navigation on lung cancer screening (LCS) low-dose computed tomography (LDCT) completion among Boston Health Care for the Homeless Program (BHCHP) patients at increased risk for lung cancer. Patient navigation is a strategy for guiding individuals through complex health systems, and we hypothesize that this may be a promising approach for helping homeless-experienced people overcome their unique barriers to obtaining LCS.

We will aim to recruit 300 people to participate in this research study; 100 will be randomly assigned to arm 1 (usual care) and 200 will be randomly assigned to arm 2 (patient navigation). Randomization of participants will be stratified by smoking status, housing status, clinical site, and whether they have previously discussed LCS with their primary care provider (PCP) to ensure balance between study groups on these variables. People assigned to the usual care arm will be referred back to their PCP for further management. People assigned to the patient navigation arm will be given the chance to work with a LCS navigator. The navigator will assist participants and their PCPs with all aspects of the LCS process in addition to offering brief tobacco counseling for current smokers.

The primary aim of the trial is to determine—among homeless-experienced people who are eligible for LCS—the effect of patient navigation on 1) LCS LDCT completion at 6 months post-enrollment and 2) LCS LDCT completion at 6 months with diagnostic follow-up of abnormal results within 1 month of the recommended time frame. Study outcomes will be assessed by examining participant health records.

Following the intervention, qualitative interviews will be conducted with 40 participants and 10 BHCHP PCPs to better understand how the LCS process unfolds in the setting of homelessness, the ways in which the navigator facilitated this process, and opportunities for improving the navigation intervention for future use.

Datat

Verifikuar së fundmi:	02/29/2020
Paraqitur së pari:	03/10/2020
Regjistrimi i vlerësuar u dorëzua:	03/10/2020
Postuar së pari:	03/12/2020
Përditësimi i fundit i paraqitur:	03/10/2020
Përditësimi i fundit i postuar:	03/12/2020
Data e fillimit të studimit aktual:	03/31/2020
Data e vlerësuar e përfundimit primar:	11/30/2021
Data e vlerësimit të përfundimit të studimit:	05/31/2022

Gjendja ose sëmundja

Lung Cancer

Tobacco Use

Homelessness

Ndërhyrja / trajtimi

Behavioral: Usual care with patient navigation

Faza

Grupet e krahëve

Krah	Ndërhyrja / trajtimi
No Intervention: Usual care without patient navigation Participants assigned to this arm will be given basic educational materials on general lung health and referred back to their PCP for management as per usual practice.
Experimental: Usual care with patient navigation Participants assigned to this arm will be informed about lung cancer screening (LCS), provided educational materials on LCS and patient navigation, and offered access to an LCS navigator who will partner with participants and PCPs to facilitate low-dose computed tomography (LDCT) completion and follow-up.	Behavioral: Usual care with patient navigation The navigator's principal role is to guide participants through the lung cancer screening (LCS) process. The navigator will work within the existing BHCHP clinical structure and collaborate with participants' PCPs to facilitate LCS low-dose computed tomography (LDCT) referral, completion, and timely follow-up by addressing participants' barriers to LCS completion and enhancing participants' self-efficacy. The navigator's secondary role is to offer brief tobacco counseling for participants who currently smoke.

Krah

Ndërhyrja / trajtimi

No Intervention: Usual care without patient navigation

Participants assigned to this arm will be given basic educational materials on general lung health and referred back to their PCP for management as per usual practice.

Experimental: Usual care with patient navigation

Participants assigned to this arm will be informed about lung cancer screening (LCS), provided educational materials on LCS and patient navigation, and offered access to an LCS navigator who will partner with participants and PCPs to facilitate low-dose computed tomography (LDCT) completion and follow-up.

Behavioral: Usual care with patient navigation

The navigator's principal role is to guide participants through the lung cancer screening (LCS) process. The navigator will work within the existing BHCHP clinical structure and collaborate with participants' PCPs to facilitate LCS low-dose computed tomography (LDCT) referral, completion, and timely follow-up by addressing participants' barriers to LCS completion and enhancing participants' self-efficacy. The navigator's secondary role is to offer brief tobacco counseling for participants who currently smoke.

Kriteret e pranimit

Moshat e pranueshme për studim	55 Years Për të 55 Years
Gjinitë e pranueshme për studim	All
Pranon Vullnetarë të Shëndetshëm	po
Kriteret	Inclusion Criteria: - Currently or formerly homeless - Have a 30 pack-year smoking history and have smoked within the past 15 years - Have a Boston HealthCare for the Homeless (BHCHP) primary care provider (PCP) - Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers Exclusion Criteria: - Prior chest computed tomography (CT) imaging in the past 12 months - Personal history of lung cancer, or current presentation with symptoms concerning for lung cancer (e.g. hemoptysis or unexplained weight loss of >15 lbs. in the past year) - Life-limiting comorbid conditions (oxygen dependence, recent cancer or chemotherapy) - Recent pneumonia or lung infection - Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate

Rezultati

Masat Kryesore të Rezultateve

1. Receipt of LDCT for LCS at 6 Months [6 months]

This outcome will be based on radiology records verifying that a chest CT was performed for LCS and interpreted according to the Lung-RADS framework.

Masat dytësore të rezultateve

1. Receipt of LDCT for LCS at 6 months with diagnostic follow-up of abnormal results Within 1 Month of the Recommended Time frame [6 months plus guideline-recommended follow-up timeframe plus 1 month]

Participants must achieve the primary outcome and, if the result is abnormal (Lung-RADS category 3 or 4), also obtain the next recommended follow-up test within 1 month of the advised timeframe based on the Lung-RADS framework. Radiology records will be obtained for participants who underwent LDCT for LCS to document the findings of the study, determine the Lung-RADS category associated with those findings, and ascertain the recommended diagnostic follow-up plan.

Lung Cancer Screening Navigation for Homeless People

Fjalë kyçe

nikotina

tumoret e mushkërive

kanceri

Abstrakt

Datat

Gjendja ose sëmundja

Ndërhyrja / trajtimi

Faza

Grupet e krahëve

Kriteret e pranimit

Rezultati

Baza e të dhënave më e plotë e bimëve medicinale e mbështetur nga shkenca