Implementation of Smoking Cessation Within NCI NCORP Community Sites (OaSiS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03291587|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Other: Key Informant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation Of Smoking Cessation Services Within NCI NCORP Community Sites With Organized Lung Cancer Screening Programs|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2021|
Experimental: Intervention - Key Informant
NCORP site coordinator will call each participant to administer a 5 minute telephone survey within 14 days of the lung cancer screening clinic visit. A participant contact log is appended. This assessment focuses on exposure to the intervention and subsequent quit attempts.
Other: Key Informant
Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
No Intervention: Usual Care
Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, <14 days, 3 months, and 6 months)
- Proportion of Patients with 7-day Sustained Smoking Abstinence Reported in the Patient Survey [ Time Frame: 6 months (after baseline) ]7-day sustained smoking abstinence will be measured by the question "Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?" in patient survey.
- Salivary Cotinine Test for Non-Smokers [ Time Frame: 6 months (after baseline) ]7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers. Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine.
- Short-term Smoking Abstinence - Patient Survey [ Time Frame: 3 months (after baseline) ]Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.
- Number of Patient Quit Attempts [ Time Frame: 3 months (after baseline) ]Patient quit attempts will be measured as part of the patient survey.
- 14 Day Patient Survey - Fidelity [ Time Frame: <= 14 days after baseline ]Fidelity to the intervention will be measured by a patient survey that asks patients if they received 18 cessation services during the screening visit.
- Key Informant Interview - Fidelity [ Time Frame: Baseline and Follow-up (8 months after baseline) ]Fidelity will be measured using the key informant interviews for intervention and usual care clinics.
- Key Informant Interview - Feasibility [ Time Frame: Baseline and Follow-up (8 months after baseline) ]Feasibility will be measured using the key informant interviews for intervention and usual care clinics.
- Key Informant Interview - Appropriateness [ Time Frame: Baseline and Follow-up (8 months after baseline) ]Appropriateness will be measured using the key informant interviews for intervention and usual care clinics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291587
|Contact: Karen Craver||(336) 716-0891||NCORP@wakehealth.edu|
Show 26 Study Locations
|Study Chair:||Kristie Foley, PhD||Wake Forest University Health Sciences|