mMe: Motivational Monitoring to Enhance Smoking Cessation... | NCT05370859

Studies
mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients

NCT05370859

Sponsor

University of Virginia

Status

Completed

Last Update Posted

Apr 3, 2024Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Smoking Behaviors
Cancer
Motivation

Interventions

There is no intervention for this study

Countries

United States

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

Apr 2024

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

Jul 18, 2022Actual

Primary Completion Date

Feb 13, 2024Actual

Completion Date

Feb 13, 2024Actual

First Submitted Date

Apr 27, 2022

First Submission Date that Met QC Criteria

May 6, 2022

First Posted Date

May 12, 2022Actual

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

Apr 1, 2024

Last Update Posted Date

Apr 3, 2024Actual

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

The objectives of this study are to pilot test a protocol of weekly assessments of motivation to quit and other relevant constructs combined with information about how to enroll in cessation programs, which will allow initial quantification of motivation to quit during cancer treatment and develop hypotheses about the impact of motivation on the decision to enroll in services.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mme Study Participants		Participants will complete a baseline survey, 11 weekly surveys, and a follow-up survey at 12 weeks	Other: There is no intervention for this study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention for this study	Other	There is no intervention or exposure for this study	Mme Study Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants who enroll in cessation services	Assessed using administrative records	12 weeks after study start

Secondary Outcomes

Measure	Description	Time Frame
Level of and change in motivation and self-efficacy to quit smoking	Assessed using self-report on the weekly and 12-week survey	Through study completion, an average of 12 weeks
Level of and change in anxiety and depression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An adult (18+)
Current smoker defined by: Has smoked 100 cigarettes in their lifetime (may be multi-tobacco users as long as they also use combustible cigarettes).
Any type of cancer (except non-melanoma skin cancer)
Anticipates receiving any of the following cancer treatments in the 3 months following enrollment: chemotherapy, surgery, immunotherapy, bone marrow or stem cell transplant, hormone therapy, or radiation
Access to the Internet

Exclusion Criteria:

Not smoked 100 cigarettes in their lifetime
< 18 years in age
Diagnosed with non-melanoma skin cancer
Not diagnosed with cancer
Does not anticipate receiving cancer treatments in the 3 months following enrollment
Has been previously enrolled in an existing Cancer Center Tobacco Treatment Program (TTP)
Not comfortable reading and responding to questions in English
No consistent access to the Internet

Accepts Healthy Volunteers

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

Patients being seen at the study recruitment sites for cancer treatment, who have a current cancer diagnosis and who are currently smoking. Other concurrent tobacco use is also acceptable.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia Cancer Center and affiliated sites		Charlottesville	Virginia	22908	United States

ID	Term
D012907	Smoking
D009369	Neoplasms