Mindfulness Based Smoking Cessation Program

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795312
• Other study ID #: H-34953
• Secondary ID: 6003740
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 2018

Study information

• Verified date: January 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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