Mindfulness Based Smoking Cessation Program

Feasibility, Acceptability and Effectiveness of Modified Mindfulness Based Stress Reduction (MBSR) for Smoking Cessation in Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Cancer
• Intervention / Treatment: Behavioral: Smoking Cessation Program

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Smoking Cessation Program; Participants will take part in a 9-week Smoking Cessation Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants engaged in smoking cessation counseling	Participants will complete a weekly intake form and a telephone based questionnaire at 3 months to assess engagement in evidence based smoking cessation counseling by completion of one of the following: (a) at least 1 visit with Boston Medical Center pulmonary smoking cessation program for individual quit plan, or (b) at least 1 telephone based Quitworks counseling session, or (c) >1 PCP or Oncology visit in which smoking cessation treatment is discussed.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with reduced stress assessed using validated Perceived Stress Scale (PSS)	Stress reduction will be assessed using validated Perceived Stress Scale (PSS)	3 months
Number of patients reporting readiness to quit smoking based on the Transtheoretical Model and Stages of Change	Patient self report of readiness to quit smoking based on stage of change: precontemplation, contemplation, preparation or action assessed on questionnaire at baseline, 9 weeks, and at 3 month follow up	3 months
Number of participants identifying a smoking quit date	Participant will report if quit date has been determined on weekly questionnaire and/or at three month follow up	3 months
Number of participants reporting 7 day smoking abstinence from cigarettes	Participant will report 7 day smoking abstinence from cigarettes on weekly questionnaire and/or at three month follow up	3 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Marjory Charlot, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Cigarette Smoking
• Other Study ID Numbers: H-34953; 6003740 (Other Grant/Funding Number: Massachusetts Society of Clinical Oncology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will not be included in any publications

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No