Clinical trial NCT02795312: Mindfulness Based Smoking Cessation Program
Official title: Feasibility, Acceptability and Effectiveness of Modified Mindfulness Based Stress Reduction (MBSR) for Smoking Cessation in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Smoking Cessation
Keywords: Cigarette Smoking
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of participants engaged in smoking cessation counseling
timeFrame: 3 months
Secondary outcomes:
measure: Number of patients with reduced stress assessed using validated Perceived Stress Scale (PSS)
timeFrame: 3 months
measure: Number of patients reporting readiness to quit smoking based on the Transtheoretical Model and Stages of Change
timeFrame: 3 months
measure: Number of participants identifying a smoking quit date
timeFrame: 3 months
measure: Number of participants reporting 7 day smoking abstinence from cigarettes
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Marjory Charlot, MD
role: PRINCIPAL_INVESTIGATOR
References: