Mindfulness Based Smoking Cessation Program

NCT ID: NCT02795312

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-03-31

Brief Summary

This is a study designed to mindfulness based stress reduction (MBSR) training program to assess feasibility and acceptability of the intervention. Participants will participate in a 9-week training program and complete pre-and post-questionnaires. Participants will have the option of participating in a follow-up focus group.

Detailed Description

The investigators will introduce a mindfulness based stress reduction (MBSR) training program at Boston Medical Center's oncology clinic to promote engagement of low-income and minority smokers with cancer in smoking cessation. This training will follow an adapted MBSR curriculum designed by and for Boston Medical Center patients with chronic pain in the Integrated Medical Group Visit research program in Family Medicine. The investigators will tailor this adapted MBSR curriculum to address smoking cessation. To test the feasibility and acceptability of our intervention, the investigators will pilot test it with 30 patients over the course of three MBSR training programs (each cohort is 9 weeks). The investigators will acquire feasibility data (number of inquiries, number of sessions attended, and satisfaction with MBSR). Additionally, pre and post questionnaires will assess readiness to quit, stress level, and satisfaction with and acceptability of MBSR after every cohort). The primary outcome is engagement in smoking cessation treatment which includes counseling and/or pharmacotherapy. Additionally, the investigators will hold a focus group after each of the 3 cohorts have completed the program to discuss acceptability of study materials as well as facilitators and barriers to participation in the training. Data collected from this study will generate preliminary data to successfully justify and secure future funding for a larger controlled study.

Conditions

Cancer; Smoking Cessation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Smoking Cessation Training Program

Participants will take part in a 9-week Smoking Cessation Program class curriculum consisting of weekly 2.5 hour classes and complete pre and post questionnaires

Group Type: EXPERIMENTAL

Smoking Cessation Program

Intervention Type: BEHAVIORAL

Participants will take part in a 9-week Smoking Cessation Program

Interventions

Smoking Cessation Program

Participants will take part in a 9-week Smoking Cessation Program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 18 or older
• smoked cigarettes in the past week
• cancer diagnosis more than 6 months
• have a scheduled visit in the oncology clinic with an oncologist or mid-level provider
• telephone access
• English speaking for screening/consenting purposes
• able and willing to participate in the study protocol and provide informed consent

Exclusion Criteria

• cancer prognosis less than 6 months
• planning to move out of the area within 6 months
• actively using evidence-based smoking cessation treatment during screening
• pregnant women and women planning on becoming pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjory Charlot, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

6003740

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-34953

Identifier Type: -

Identifier Source: org_study_id