Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

Malignant Solid Neoplasm Clinical Trial

Official title:

A Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941858
• Other study ID #: OSU-22271
• Secondary ID: NCI-2023-04163
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 31, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Receive standard cessation treatments

Procedure:
• Carbon Monoxide Measurement
Undergo CO test

Other:
• Internet-Based Intervention
Receive access to WaQi program

Drug:
• Nicotine Replacement
Receive referral for NRT

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

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CO verification	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
Primary	Cigarette Dependence Scale (12 item)	This outcome will be assessed by the participants completing self-administered online survey that includes 12 questions.	Up to 6 months post-intervention
Primary	Hospital Anxiety and Depression Scale	This outcome will be assessed by the participants completing a self-administered online survey that includes 14 questions.	Up to 6 months post-intervention
Primary	Physical Activity (7 item)	This outcome will be assessed by the participants completing self-administered online survey that includes 7 questions.	Up to 6 months post-intervention

External Links

•   The Jamesline