Smoking BehaviorsmMeNCT05370859
mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients
An observational study of Smoking Behaviors and Cancer, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Behaviors, Cancer, Motivation
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 13 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Cancer Center and affiliated sites
Charlottesville, Virginia, 22908
About this study
Official title: 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.
- Conditions
- Smoking Behaviors, Cancer, Motivation
- Being tested
- There is no intervention for this study
- Medical subject headings
- Smoking, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention for this studyOther
There is no intervention or exposure for this study
| Study group | Role | What they receive |
|---|---|---|
| Mme Study Participants | Participants will complete a baseline survey, 11 weekly surveys, and a follow-up survey at 12 weeks Receives: Other: There is no intervention for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who enroll in cessation services
Assessed using administrative records
Measured: 12 weeks after study start
Secondary outcomes (3)
Level of and change in motivation and self-efficacy to quit smoking
Assessed using self-report on the weekly and 12-week survey
Measured: Through study completion, an average of 12 weeks
Level of and change in anxiety and depression
Assessed using self-report (PHQ-4) on the weekly and 12-week survey
Measured: Through study completion, an average of 12 weeks
Number of smoking quit attempts
Assessed using self-report on the weekly and 12-week survey
Measured: 12 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start18 Jul 2022
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Wiseman, MPH, PhD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370859
- Sponsor's protocol ID
- 18184
- Acronym
- mMe
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients Pilot Study
- ClinicalTrials.gov ID
- NCT05370859
- Acronym / sponsor ID
- mMe / 18184
- Conditions
- Smoking Behaviors, Cancer, Motivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mme Study Participants | – | Other: There is no intervention for this studyParticipants will complete a baseline survey, 11 weekly surveys, and a follow-up survey at 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention for this studyThere is no intervention or exposure for this study | Other | Mme Study Participants |
Primary outcome
Number of participants who enroll in cessation services
Time frame: 12 weeks after study start
Assessed using administrative records
3 secondary outcomes
Level of and change in motivation and self-efficacy to quit smoking
Time frame: 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
Number of smoking quit attempts
Time frame: 12 weeks after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Behaviors and Cancer, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who enroll in cessation services (time frame: 12 weeks after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.