TELESCOPE- TELEhealth Delt beslutningstakende coaching
TELEhealth Shared Decision-making Coaching for lungekreftscreening i primærhelsetjenesten (TELESCOPE)
Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict.
Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers.
Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The investigators' primary objective is to compare the effectiveness of the TELESCOPE intervention vs. enhanced usual care (EUC) on shared decision-making (SDM) for lung cancer screening.
Secondary objectives are to test the effectiveness of the TELESCOPE intervention vs. EUC on screening uptake, adherence with diagnostic testing and annual testing, and smoking cessation referrals and receipt of tobacco treatment for current smokers. The investigators will also use a mixed methods approach to evaluate the implementation potential of navigator-led decision coaching for lung cancer screening (LCS ) and identify components and organizational and individual level characteristics that might facilitate or interfere with successful implementation.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08901
- Rutgers Cancer Institute
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Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas MD Anderson Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Inclusion Criteria Cluster Randomized Trial
Eligibility of patients for the cluster randomized trial will follow United States Preventive Services Task Force criteria for lung cancer screening. Specifically, patients must:
- Be 50 to 77 years of age
- Be a current or former smoker having quit within the past 15 years
- Have at least a 20 pack-year smoking history
- Be scheduled for a non-acute care visit at one of the study sites. Interviews (N=50)
Participants completing the semi-structured interviews will be:
- A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator (n=20) at one of the participating sites or a TELESCOPE study patient navigator (n=7) and nurse navigator (n = 3)
- Age 18 or older
- Fluent in English Online surveys (N=130)
Providers completing online PRISM construct surveys will be:
- A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator
- Age 18 or older
- Fluent in English
Exclusion Criteria:
- Cluster Randomized Trial
Excluded will be patients who:
- Do not speak English
- Have a history lung cancer
- Were screened for lung cancer within the past 12 months
- Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider
- Are unable to provide informed consent Interviews (N=50)
Providers/administrators will be excluded if they:
- Are unable to provide informed consent Online surveys (N=130)
- Are unable to provide informed consent
- Women who are pregnant. English proficiency is required for the completion of surveys, and the intervention will be conducted in English.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: TELESCOPE intervention
Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. If a participant is a current smoker then they are offered and navigated to evidence-based smoking cessation. If the participant is interested in screening, an LDCT is ordered. Support for screening, diagnostic testing and oncology care will be provided as needed from the Nurse Navigators. |
The TELESCOPE intervention involves three complementary components: 1) decision aid and coaching for LCS, 2) referral of current smokers to evidence-based smoking cessation services, and 3) for participants interested in screening, navigation to complete LCS and diagnostic testing and oncology care as needed |
|
Ingen inngripen: Enhanced usual care (EUC)
Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. Primary and secondary outcome data related to the office visit will be collected. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess shared decision making
Tidsramme: The change in baseline, three months and five years
|
Semi-structured interviews (qualitative data) |
The change in baseline, three months and five years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Tobacco treatment referral
Tidsramme: The change in baseline, three months and five years
|
Semi-structured interviews (qualitative data) |
The change in baseline, three months and five years
|
|
Uptake of Low-Dose CT Screening for Lung Cancer
Tidsramme: Within 6 months post-intervention
|
Proportion of participants who complete low-dose CT (LDCT) lung cancer screening within 6 months post-intervention. |
Within 6 months post-intervention
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Receipt of tobacco treatment
Tidsramme: The change in baseline, three months and five years
|
Semi-structured interviews (qualitative data). |
The change in baseline, three months and five years
|
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Completion of diagnostic testing
Tidsramme: The change in baseline, three months and five years
|
Semi-structured interviews (qualitative data). |
The change in baseline, three months and five years
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Anita Y Kinney, PhD, RN, Rutgers Cancer Institute
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. BMC Prim Care. 2024 Oct 18;25(1):373. doi: 10.1186/s12875-024-02610-2.
- Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making Coaching and Navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. Res Sq [Preprint]. 2024 Apr 22:rs.3.rs-4254047. doi: 10.21203/rs.3.rs-4254047/v1.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 132207
- Pro2022000340 (Annen identifikator: Rutgers)
- 1R01HL158850-01A1 (U.S. NIH-stipend/kontrakt)
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