mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients

• Sponsor: University of Virginia (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05370859
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Behaviors; Cancer; Motivation	Other: There is no intervention for this study

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients Pilot Study
• Anticipated Study Start Date: May 11, 2022
• Anticipated Primary Completion Date: Apr 10, 2023
• Anticipated Study Completion Date: Apr 10, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Number of participants who enroll in cessation services [12 weeks after study start]

   Assessed using administrative records

Secondary Outcome Measures

1. Level of and change in motivation and self-efficacy to quit smoking [Through study completion, an average of 12 weeks]

   Assessed using self-report on the weekly and 12-week survey

2. Level of and change in anxiety and depression [Through study completion, an average of 12 weeks]

   Assessed using self-report (PHQ-4) on the weekly and 12-week survey

3. Number of smoking quit attempts [12 weeks after study start]

   Assessed using self-report on the weekly and 12-week survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Cancer Center and affiliated sites	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Virginia
• ClinicalTrials.gov Identifier: NCT05370859
• Other Study ID Numbers: 18184
• First Posted: May 12, 2022
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 12, 2022