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Completed

NCT Number: NCT02795312

Mindfulness Based Smoking Cessation Program

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.

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Key information

Conditions

Cancer Behavior Cigarette Smoking Health Behavior Neoplasms Smoking Smoking Cessation Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smoking cessation program

Behavioral

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

Primary outcomes

  1. Number of participants engaged in smoking cessation counseling

    Time frame: 3 months

    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.

Secondary outcomes

  1. Number of patients with reduced stress assessed using validated Perceived Stress Scale (PSS)

    Time frame: 3 months

    Stress reduction will be assessed using validated Perceived Stress Scale (PSS)

  2. Number of patients reporting readiness to quit smoking based on the Transtheoretical Model and Stages of Change

    Time frame: 3 months

    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. Number of participants identifying a smoking quit date

    Time frame: 3 months

    Participant will report if quit date has been determined on weekly questionnaire and/or at three month follow up

  4. Number of participants reporting 7 day smoking abstinence from cigarettes

    Time frame: 3 months

    Participant will report 7 day smoking abstinence from cigarettes on weekly questionnaire and/or at three month follow up

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 10, 2016
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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