NCT04149249

Brief Summary

This clinical trial studies the impact of CONNECT on biochemically confirmed smoking abstinence among diverse current smokers who are undergoing lung cancer screening.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

3.8 years

First QC Date

October 9, 2019

Last Update Submit

September 14, 2023

Conditions

Smoking Cessation

Keywords

quittingsmokingsmoking cessation toolsmoking cessationquit smokingsmoking cessation resourcessmoking cessation barrierssmoking cessation intervention tool

Outcome Measures

Primary Outcomes (3)

  • Assessing 30-day smoking abstinence at 3 months post lung cancer screening.

    Biochemically confirmed 30-day smoking abstinence at 3 months post lung cancer screening.

    Up to 3 months from date of lung cancer screening appointment.

  • Number of participants with Self-reported quit attempts

    Self-reported quit attempts will be measured to assess smoking behavioral changes.

    Up to 3 months from date of lung cancer screening appointment.

  • Percentage of participants who used of evidence-based smoking cessation resources

    Use of evidence-based smoking cessation resources such as quitline, pharmacotherapy or counseling will be measured to assess smoking behavioral changes.

    Up to 3 months from date of lung cancer screening appointment.

Secondary Outcomes (2)

  • Change in Participation rate over time

    Up to 18 months.

  • Change in intervention component completion rates over time

    Up to 18 months.

Study Arms (2)

Experimental: Intervention Group (CONNECT)

EXPERIMENTAL

Patients complete CONNECT, the Video Doctor over 30-45 minutes on an iPad in the waiting room before their lung cancer screening test appointment.

Other: Computer-Assisted Intervention Video Doctor

Control Group

ACTIVE COMPARATOR

Patients complete CONNECT assessment only over 30-45 minutes on an iPad in the waiting room before their lung cancer screening test appointment. Individuals who are randomized to the control group will undergo the same assessment questions and all follow up assessments like the intervention group. Instead of viewing and participating in the interactive Video Doctor about Smoking Cessation, they receive a handout containing smoking cessation resources.

Other: Computer-Assisted Intervention no Video Doctor

Interventions

Computer-Assisted Intervention Video DoctorOTHER

Complete CONNECT: participants will undergo in-person assessment questions and follow-up assessment questions. They will view and participate in the interactive Video Doctor about Smoking Cessation.

Experimental: Intervention Group (CONNECT)
Computer-Assisted Intervention no Video DoctorOTHER

Individuals who are randomized to the control group will undergo the same assessment questions and all follow up assessments like the intervention group. Instead of viewing and participating in the interactive Video Doctor about Smoking Cessation, they receive a handout containing smoking cessation resources.

Control Group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55-80
  • Male or female
  • English speaking
  • Have an already scheduled low-dose computed tomography (LDCT) visit
  • Smoke at least 1 cigarette in the last 7 days
  • Have a phone that can receive text messages.

You may not qualify if:

  • Younger than 55 or older than 80
  • Does not speak English
  • Does not have a scheduled low-dose computed tomography (LDCT) visit
  • Does not smoke at least 1 cigarette in the last 7 days
  • Does not have a phone that can receive text messages.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

  • Tsoh JY, Kohn MA, Gerbert B. Promoting smoking cessation in pregnancy with Video Doctor plus provider cueing: a randomized trial. Acta Obstet Gynecol Scand. 2010;89(4):515-523. doi: 10.3109/00016341003678419.

    PMID: 20196678BACKGROUND

  • van der Aalst CM, de Koning HJ, van den Bergh KA, Willemsen MC, van Klaveren RJ. The effectiveness of a computer-tailored smoking cessation intervention for participants in lung cancer screening: a randomised controlled trial. Lung Cancer. 2012 May;76(2):204-10. doi: 10.1016/j.lungcan.2011.10.006. Epub 2011 Nov 4.

    PMID: 22054915BACKGROUND

  • Clark MM, Cox LS, Jett JR, Patten CA, Schroeder DR, Nirelli LM, Vickers K, Hurt RD, Swensen SJ. Effectiveness of smoking cessation self-help materials in a lung cancer screening population. Lung Cancer. 2004 Apr;44(1):13-21. doi: 10.1016/j.lungcan.2003.10.001.

    PMID: 15013579BACKGROUND

  • Marshall HM, Courtney DA, Passmore LH, McCaul EM, Yang IA, Bowman RV, Fong KM. Brief Tailored Smoking Cessation Counseling in a Lung Cancer Screening Population is Feasible: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2016 Jul;18(7):1665-9. doi: 10.1093/ntr/ntw010. Epub 2016 Feb 1.

    PMID: 26834052BACKGROUND

  • Ferketich AK, Otterson GA, King M, Hall N, Browning KK, Wewers ME. A pilot test of a combined tobacco dependence treatment and lung cancer screening program. Lung Cancer. 2012 May;76(2):211-5. doi: 10.1016/j.lungcan.2011.10.011. Epub 2011 Nov 15.

    PMID: 22088938BACKGROUND

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Judith Walsh, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2019

First Posted

November 4, 2019

Study Start

August 21, 2019

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)