Quit4hlth: Enhancing Tobacco and Cancer Control Through F... | NCT03038542

Studies
Quit4hlth: Enhancing Tobacco and Cancer Control Through Framed Text Messages

NCT03038542

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Jul 17, 2018Actual

Enrollment

600Actual

Phase

Not Applicable

Conditions

Smoking

Interventions

Gain-framed text messages
Standard care text messages

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Jul 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Jan 30, 2017

First Submission Date that Met QC Criteria

Jan 30, 2017

First Posted Date

Jan 31, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2018

Last Update Posted Date

Jul 17, 2018Actual

Name	Class
Roswell Park Cancer Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates a text messaging intervention through a smokers' quitline. Smokers will either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored, standard care text messages, both combined with standard quitline treatment. We hypothesize that the gain-framed text message intervention will increase cessation rates at 30 weeks as compared to standard care text messages.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Text Arm	Experimental		Behavioral: Gain-framed text messages
Standard Text Arm	Active Comparator		Behavioral: Standard care text messages

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gain-framed text messages	Behavioral		Treatment Text Arm
Standard care text messages

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survey of smoking status	smoking or abstinent	Week 30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) call the Quitline requesting assistance with quitting smoking, 2) be 18+ years old, 3) speak English, 4) have a verified New York address, and 5) opt into the standard Quitline texting protocol.

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Toll, PhD	Medical University of South Carolina	Principal Investigator

Locations

Not provided