CancerNCT02795312
Mindfulness Based Smoking Cessation Program
A study testing Smoking Cessation Program in people with Cancer and Smoking Cessation, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Smoking Cessation
- What is being tested?
- Smoking Cessation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability and Effectiveness of Modified Mindfulness Based Stress Reduction (MBSR) for Smoking Cessation in Cancer Patients
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.
Read the 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.
- Conditions
- Cancer, Smoking Cessation
- Being tested
- Smoking Cessation Program
- Keywords
- Cigarette Smoking
- Medical subject headings
- Neoplasms, Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation ProgramBehavioural
Participants will take part in a 9-week Smoking Cessation Program
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Smoking Cessation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Number of patients with reduced stress assessed using validated Perceived Stress Scale (PSS)
Stress reduction will be assessed using validated Perceived Stress Scale (PSS)
Measured: 3 months
Number of patients reporting readiness to quit smoking based on the Transtheoretical Model and Stages of Change
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
Measured: 3 months
Number of participants identifying a smoking quit date
Participant will report if quit date has been determined on weekly questionnaire and/or at three month follow up
Measured: 3 months
Number of participants reporting 7 day smoking abstinence from cigarettes
Participant will report 7 day smoking abstinence from cigarettes on weekly questionnaire and/or at three month follow up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjory Charlot, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795312
- Sponsor's protocol ID
- H-34953
- Other IDs
- 6003740
- Status last verified
- Jan 2020
- First submitted
- 1 Jun 2016
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be included in any publications
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Effectiveness of Modified Mindfulness Based Stress Reduction (MBSR) for Smoking Cessation in Cancer Patients
- ClinicalTrials.gov ID
- NCT02795312
- Acronym / sponsor ID
- H-34953
- Conditions
- Cancer, Smoking Cessation
- Keywords
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Training Program | Experimental | Behavioral: Smoking Cessation ProgramParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation ProgramParticipants will take part in a 9-week Smoking Cessation Program | Behavioural | Smoking Cessation Training Program |
Primary outcome
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.
4 secondary outcomes
Number of patients with reduced stress assessed using validated Perceived Stress Scale (PSS)
Time frame: 3 months
Number of patients reporting readiness to quit smoking based on the Transtheoretical Model and Stages of Change
Time frame: 3 months
Number of participants identifying a smoking quit date
Time frame: 3 months
Number of participants reporting 7 day smoking abstinence from cigarettes
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No. Individual patient data will not be included in any publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjory Charlot, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Program in people with Cancer and Smoking Cessation, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants engaged in smoking cessation counseling (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.