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Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05941858
Recruitment Status : Not yet recruiting
First Posted : July 12, 2023
Last Update Posted : November 2, 2023
Sponsor:
Information provided by (Responsible Party):
Ce Shang, Ohio State University Comprehensive Cancer Center

Study Description
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Brief Summary:
This clinical trial evaluates an online Tai Chi intervention to promote smoking cessation among cancer survivors. Tai chi is a practice that involves a series of slow gentle movements and physical postures, a meditative state of mind, and controlled breathing. It is a gentle form of exercise that can be done while sitting or standing and does not involve any medications or medical procedures. Tai chi originated as an ancient martial art in China. Over the years, it has become more focused on health promotion and rehabilitation. The use of Tai Chi may be beneficial for cancer patients who want to quit smoking.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Other: Best Practice Procedure: Carbon Monoxide Measurement Other: Internet-Based Intervention Drug: Nicotine Replacement Other: Survey Administration Other: Tai Chi Early Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To assess the feasibility of the Tai Chi intervention to promote smoking cessation among cancer survivors.

SECONDARY OBJECTIVE:

I. Collect preliminary RCT data on the efficacy of our Tai Chi intervention for the potential of scaling up to a more extensive study.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive access to the online WaQi program to practice Tai Chi supervised and home-based over 8 weeks. Participants also receive standard cessation treatment that includes a prescription or recommendation for nicotine replacement therapy (NRT) and undergo carbon monoxide (CO) testing on study.

ARM II: Participants receive standard cessation treatment that includes a prescription or recommendation for NRT 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Study staff conducting data management and analyses.
Primary Purpose: Supportive Care
Official Title: A Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors
Estimated Study Start Date : December 31, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (Tai Chi)
Participants receive access to the online WaQi program to practice Tai Chi supervised and home-based over 8 weeks. Participants also receive standard cessation treatment that includes a prescription or recommendation for NRT and CO testing on study.
 Other: Best Practice
Receive standard cessation treatments
Other Names:
  • standard of care
  • standard therapy

Procedure: Carbon Monoxide Measurement
Undergo CO test
Other Names:
  • Carbon Monoxide
  • CMONOX

Other: Internet-Based Intervention
Receive access to WaQi program

Drug: Nicotine Replacement
Receive referral for NRT
Other Names:
  • Nicotine Replacement Therapy
  • NRT

Other: Survey Administration
Ancillary studies

Other: Tai Chi
Practice Tai Chi
Active Comparator: Arm II (Standard cessation)
Participants receive standard cessation treatment that includes a prescription or recommendation for NRT 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.
 Other: Best Practice
Receive standard cessation treatments
Other Names:
  • standard of care
  • standard therapy

Procedure: Carbon Monoxide Measurement
Undergo CO test
Other Names:
  • Carbon Monoxide
  • CMONOX

Other: Internet-Based Intervention
Receive access to WaQi program

Drug: Nicotine Replacement
Receive referral for NRT
Other Names:
  • Nicotine Replacement Therapy
  • NRT

Other: Survey Administration
Ancillary studies

Other: Tai Chi
Practice Tai Chi


Outcome Measures
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Primary Outcome Measures :
  1. CO verification [ Time Frame: Up to 6 months post-intervention ]
    Will be assessed by the amount of carbon monoxide in a participant's breath using a portable carbon monoxide monitor (iCOquit), which can be plugged into participants' smartphones.

  2. 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.

  3. Hospital Anxiety and Depression Scale [ Time Frame: Up to 6 months post-intervention ]
    This outcome will be assessed by the participants completing a self-administered online survey that includes 14 questions.

  4. Physical Activity (7 item) [ Time Frame: Up to 6 months post-intervention ]
    This outcome will be assessed by the participants completing self-administered online survey that includes 7 questions.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer survivors (at least 3 months post-treatment, treatments include surgery, chemo, radiation, immuno-therapy)
  • Adults aged 21 years and older
  • Report smoking cigarettes 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

Exclusion Criteria:

  • Non-cancer patients or cancer patients who haven't had any treatment, or the last treatment the patient had is within 3 months at participant screening)
  • Patients under 21 years old
  • 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
  • Eligible, but sampling quotas full
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05941858


Contacts
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Contact: The Ohio State Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Contact: Ce Shang, PhD    614-685-3741    ce.shang@osumc.edu   
Principal Investigator: Ce Shang, PhD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Ce Shang, PhD Ohio State University Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: Ce Shang, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05941858    
Other Study ID Numbers: OSU-22271
NCI-2023-04163 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 12, 2023    Key Record Dates
Last Update Posted: November 2, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Nicotine
Carbon Monoxide
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Gasotransmitters