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Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05941858
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
28
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • 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:
  1. To assess the feasibility of the Tai Chi intervention to promote smoking cessation among cancer survivors.
SECONDARY OBJECTIVE:
  1. 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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

    Primary Outcome Measures

    1. CO verification [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) [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 [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) [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

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    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
    First Posted:
    Jul 12, 2023
    Last Update Posted:
    Jul 17, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Nicotine
    Carbon Monoxide

    Study Results

    No Results Posted as of Jul 17, 2023