- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05941858
Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors
A Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors
Study Overview
Status
Conditions
Detailed Description
Aim 1: The primary objective of this study is to pilot an online Tai Chi intervention promoting smoking cessation among cancer survivors1.
Aim 2: Examine whether an online Tai Chi intervention reduces cigarette dependence among cancer survivors who are aged 21 and are interested in quitting smoking.
Aim 3: Test whether an online Tai Chi intervention increases quit attempts and cessation abstinence among cancer survivors who are aged 21 or older and are interested in quitting smoking.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants participate in an 8-week supervised online WaQi/Tai Chi program. Participants receive standard cessation treatment which includes receiving a document highlighting smoking cessation resources.
ARM II: Participants receive standard cessation treatment which includes receiving a document highlighting smoking cessation resources. Participants also receive an 8-week online Tai Chi self-administered teaching module subscription at the end of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cancer survivor (i.e., have had a cancer diagnosis)
- Age 21 years and older
- English speaking/reading
- Report smoking tobacco in the past 30 days
- Report at least moderate interest in quitting smoking (>= 3 on a Likert type scale with 5 being very extremely interested)
- Can participate in Zoom calls for orientation and intervention
- Have access to a smartphone or tablet
- Willing to download a free application (app)
- Can commit to the 8-weeks intervention (WaQi program)
- Are not currently or have not regularly practiced Tai Chi in the last 6 months
- Willing to blow into a device (for carbon monoxide measurements)
Exclusion Criteria:
- Non-cancer survivors
- Patients under 21 years old
- Non-English speaking/reading
- Non-smokers in the past 30 days
- Report lower than moderate interest in quitting smoking (< 3 on a Likert type scale with 5 being very extremely interested)
- Cannot to participate Zoom calls for orientation and intervention
- No access to a smartphone or tablet
- Not willing to download a free app
- Cannot commit to the intervention
- Has practiced Tai Chi regularly in the last 6 months
- Not willing to blow into a device
- Eligible, but sampling quotas full
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (Tai Chi)
Participants receive access to the online WaQi program to practice Tai Chi supervised over 60 minutes BIW and home-based over 10 minutes five days a week for 8 weeks.
Participants also receive a document highlighting NCI resources for quitting smoking including NCI's tollfree Quitline number, state Quitline numbers and other resources, and undergo CO testing on study.
|
Ancillary studies
Undergo CO test
Other Names:
Practice Tai Chi
Receive smoking cessation resource document
Other Names:
Receive access to WaQi/Tai Chi program
|
|
Active Comparator: Arm II (Standard cessation)
Participants receive a document highlighting NCI resources for quitting smoking including NCI's tollfree Quitline number, state Quitline numbers and other resources, and undergo CO testing on study.
Participants also receive an 8-week online Tai Chi self-administered teaching module subscription at the end of the study.
|
Ancillary studies
Undergo CO test
Other Names:
Practice Tai Chi
Receive smoking cessation resource document
Other Names:
Receive access to WaQi/Tai Chi program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking cessation
Time Frame: At baseline, 4 weeks after start of intervention, and 1 week, 3 months and 6 months post-intervention
|
Will be assessed by the participants in both groups by carbon monoxide (CO) verification and self-administered online surveys.
|
At baseline, 4 weeks after start of intervention, and 1 week, 3 months and 6 months post-intervention
|
|
Quit attempts
Time Frame: Will be assessed by the participants in both groups by CO verification and self-administered online surveys.
|
Will be assessed by the participants in both groups by CO verification and self-administered online surveys.
|
Will be assessed by the participants in both groups by CO verification and self-administered online surveys.
|
|
Smoking abstinence
Time Frame: At baseline, 4 weeks after start of intervention, and 1 week, 3 months and 6 months post-intervention
|
Will be assessed by the amount of CO in a participant's breath using a portable carbon monoxide monitor, which is synced to the participants' smartphones and will ask participants to complete a brief smoking habit survey.
|
At baseline, 4 weeks after start of intervention, and 1 week, 3 months and 6 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cigarette Dependence Scale (12 item)
Time Frame: Up to 6 months post-intervention
|
This outcome will be assessed by the participants completing self-administered online survey that includes 12 questions.
|
Up to 6 months post-intervention
|
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Secondary measures that may contribute to smoking
Time Frame: At baseline, 1 week, 3 months and 6 months post-intervention
|
Will include measures such as, anxiety and depression, physical activity, and pain.
Will be assessed by the participants in both groups by self-administered online surveys.
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At baseline, 1 week, 3 months and 6 months post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ce Shang, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavior
- Health Behavior
- Neoplasms
- Smoking Cessation
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Inorganic Chemicals
- Manufactured Materials
- Technology, Industry, and Agriculture
- Oxides
- Oxygen Compounds
- Gases
- Carbon Compounds, Inorganic
- Carbon Monoxide
- Tai Ji
- Smoking Devices
Other Study ID Numbers
- OSU-22271
- NCI-2023-04163 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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