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临床试验/NCT02795312
NCT02795312已完成不适用

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

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Number of participants engaged in smoking cessation counseling

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Number of participants engaged in smoking cessation counseling

时间窗: 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.

次要结局

  • Number of participants identifying a smoking quit date(3 months)
  • Number of participants reporting 7 day smoking abstinence from cigarettes(3 months)
  • Number of patients with reduced stress 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(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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