mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients (mMe)

April 1, 2024 updated by: Kara Wiseman, MPH, PhD, University of Virginia

Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center and affiliated sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
There is no intervention or exposure for this study

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of and change in motivation and self-efficacy to quit smoking
Time Frame: Through study completion, an average of 12 weeks
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
Time Frame: Through study completion, an average of 12 weeks
Assessed using self-report (PHQ-4) on the weekly and 12-week survey
Through study completion, an average of 12 weeks
Number of smoking quit attempts
Time Frame: 12 weeks after study start
Assessed using self-report on the weekly and 12-week survey
12 weeks after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2022

Primary Completion (Actual)

February 13, 2024

Study Completion (Actual)

February 13, 2024

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 18184

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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