NCT02795312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

June 1, 2016

Last Update Submit

January 2, 2020

Conditions

Keywords

Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Number of participants identifying a smoking quit date

    3 months

  • Number of participants reporting 7 day smoking abstinence from cigarettes

    3 months

Study Arms (1)

Smoking Cessation Training Program

EXPERIMENTAL

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

Interventions

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

Smoking Cessation Training Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

NeoplasmsSmoking CessationCigarette Smoking

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorTobacco SmokingSmokingTobacco Use

Study Officials

  • Marjory Charlot, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 10, 2016

Study Start

July 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Individual patient data will not be included in any publications

Locations