CONNEXION à LungCare
This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation and lung cancer screening between patients and providers. Shared decision making is a patient care model in which providers offer information regarding risks and benefits, patients express their values and preferences, and then healthcare decisions are jointly discussed between the patient and provider. Patient education, aided by decision support tools, can increase patients' knowledge, decrease their decisional conflict, promote decision making, and improve the patients' perception of risk. CONNECTing to LungCare is an interactive education intervention that addresses lung cancer screening and smoking cessation and provides participants with a tailored summary that may make them more likely to have shared decision-making discussions with their providers about smoking cessation and lung cancer screening.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
Aim 1: Development of the smoking cessation and LCS intervention, CONNECTing to LungCare.
Aim 2: Test CONNECTing to Lung Care for Feasibility and Acceptability (N=120)
Aim 3: To qualitatively evaluate feasibility and acceptability of the intervention and study procedures from the perspectives of patients, providers, staff and administrators and other stakeholders.
OUTLINE:
BETA TESTING: Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement.
FEASIBILITY TRIAL: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the CONNECTing to LungCare intervention, including education about the benefits and risks of LCS and the importance of shared decision making, computerized assessments of the participant's smoking status, readiness to quit and concerns about quitting, and video segments tailored to the participant's responses to assessment questions, prior to their primary care appointment. Participants and their providers receive a tailored summary of the participant's concerns and barriers to quitting to enhance motivation for smoking cessation and shared decision making discussions. Participants then receive up to 3 follow-up phone calls over 10-15 minutes each encouraging them to follow up with their provider, to complete the shared decision-making conversation, obtain LCS if appropriate, and access smoking cessation resources. Participants may also receive brief, tailored follow-up text messages that include links to video segments or cessation resources 1-3 times weekly.
GROUP II: Participants receive usual care from their provider at their primary care appointment.
After completion of study intervention, participants are followed up at 1 and 3 months.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
San Francisco, California, États-Unis, 94143
- University of California, San Francisco
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- English, Spanish and Cantonese speaking
- Age >= 18 years old
- Primary care patients at the University of California, San Francisco (UCSF) General Internal Medicine (GIM) clinics
- Must be current smokers and/or candidates for Lung Cancer Screening (LCS).
Key Informant Interviews:
- Must be working in one of the clinics participating in CONNECTing to LungCare.
Exclusion Criteria:
- Not a current smoker
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Beta testing (CONNECTing to LungCare, feedback)
Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement. |
Ancillary studies Multimedia program administered either remotely or in person
Autres noms:
|
|
Expérimental: Feasibility trial, Group I (CONNECTing to LungCare)
Participants receive the CONNECTing to LungCare intervention, including education about the benefits and risks of LCS and the importance of shared decision making, computerized assessments of the participant's smoking status, readiness to quit and concerns about quitting, and video segments tailored to the participant's responses to assessment questions, prior to their primary care appointment. Participants and their providers receive a tailored summary of the participant's concerns and barriers to quitting to enhance motivation for smoking cessation and shared decision-making discussions. Participants then receive up to 3 follow-up phone calls over 10-15 minutes each encouraging them to follow up with their provider, to complete the shared decision-making conversation, obtain LCS if appropriate, and access smoking cessation resources. Participants may also receive brief, tailored follow-up text messages that include links to video segments or cessation resources 1-3 times weekly. |
Ancillary studies Multimedia program administered either remotely or in person
Autres noms:
Saliva samples will be collected from each participant
Autres noms:
|
|
Comparateur actif: Feasibility trial, Group II (usual care)
Participants receive usual care from their provider at their primary care appointment. |
Ancillary studies Multimedia program administered either remotely or in person
Autres noms:
Saliva samples will be collected from each participant
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment rate
Délai: Up to 1 year
|
The percentage of participants who were contacted and joined the study will be reported. |
Up to 1 year
|
|
Retention rates
Délai: Up to 1 year
|
The percentage of participants who joined the study and completed the program will be reported. |
Up to 1 year
|
|
Adherence rates
Délai: Up to 1 year
|
The percentage of participants who joined the study and completed all tasks within the program will be reported. |
Up to 1 year
|
|
Overall time required to recruit to the target sample size (Feasibility Cohort)
Délai: Up to 1 year
|
The overall time in weeks required to recruit participants for the feasibility cohort will be reported. |
Up to 1 year
|
|
Number of eligible participants
Délai: Up to 1 year
|
The number of eligible participants required to recruit the required sample size will be reported |
Up to 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Smoking cessation rates
Délai: At 3 months
|
Will evaluate the impact of the intervention on smoking cessation rates. Rates of smoking cessation will be measured by self-report and validated by salivary cotinine levels. |
At 3 months
|
|
Lung cancer screening (LCS) rates
Délai: Up to 3 months
|
Rates of LCS will be evaluated through review of the electronic health record (EHR) |
Up to 3 months
|
|
Shared decision making about LCS
Délai: Up to 3 months
|
Evidence of shared decision-making conversation will be obtained through one week follow up phone call and with review of the EHR three months after the primary care physician visit. |
Up to 3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Judith Walsh-Cassidy, MD, University of California, San Francisco
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 226311
- NCI-2023-10506 (Identificateur de registre: NCI Clinical Trials Reporting Program (CTRP))
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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