Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

November 1, 2023 updated by: Ce Shang, Ohio State University Comprehensive Cancer Center

A Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

48

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Ce Shang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 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: Survey Administration
Ancillary studies
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: 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: Survey Administration
Ancillary studies
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: Tai Chi
Practice Tai Chi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months post-intervention
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
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.
Up to 6 months post-intervention
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.
Up to 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Ce Shang, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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