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Trial record 5 of 2035 for:    Smoking Cessation

Mindfulness Based Smoking Cessation Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02795312
Recruitment Status : Active, not recruiting
First Posted : June 10, 2016
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Cancer Smoking Cessation Behavioral: Smoking Cessation Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility, Acceptability and Effectiveness of Modified Mindfulness Based Stress Reduction (MBSR) for Smoking Cessation in Cancer Patients
Study Start Date : July 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795312


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Marjory Charlot, MD Boston Medical Center

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02795312     History of Changes
Other Study ID Numbers: H-34953
6003740 ( Other Grant/Funding Number: Massachusetts Society of Clinical Oncology )
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be included in any publications

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

Keywords provided by Boston Medical Center:
Cigarette Smoking