JeffQuit Group Therapy Program for Smoking Cessation in Patients With a History of Cancer

Not Applicable

Withdrawn

• Conditions: Malignant Neoplasm; Current Smoker
• Interventions: Other: Tobacco Cessation Counseling; Other: Support Group Therapy; Other: Quality-of-Life Assessment

• Registration Number: NCT02591433
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

This pilot clinical trial studies how well the "JeffQuit" group therapy program works in enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group therapy to provide psychological support and address the mental need for smoking, the habit or routine it creates, and the physical need for nicotine. It is not yet known how well the JeffQuit program will work in helping patients with a history of cancer to stop smoking.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the initial effectiveness of the JeffQuit program on smoking cessation in cancer patients.

II. To assess the quality of life improvements related to the JeffQuit smoking cessation program in cancer patients.

OUTLINE:

Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.

After completion of study, patients are followed up at 6 months.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-11
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. History of cancer
2. Current smoker
3. Willing to provide consent and participate in the JeffQuit program
4. Referral by a Kimmel Cancer Center provider

Exclusion Criteria

1. Any significant active medical disorder or physical condition that could reasonably be expected to interfere with the ability of the patient to quit smoking as determined by the Principal Investigator (PI)
2. Currently participating in another smoking cessation program
3. Currently receiving chemotherapy or radiation therapy that would interfere with their ability to participate in the JeffQuit program
4. Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
5. Patients with current alcohol or drug abuse
6. Enrollment in active clinical trial/ experimental therapy within the prior 30 days
7. Are in the terminal stages of illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (JeffQuit group therapy)	Tobacco Cessation Counseling	Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.
Supportive care (JeffQuit group therapy)	Quality-of-Life Assessment	Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.
Supportive care (JeffQuit group therapy)	Support Group Therapy	Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who are adherent to smoking abstinence	Up to 6 months after completion of intervention	Calculated along with a 1-sided 95% exact confidence interval. An exact binomial test (with a one-sided alpha of 0.05) will also be used to test whether adherence is greater than 60%.

Secondary Outcome Measures

Name	Time	Method
Change in Smoking Cessation Quality of Life (SCQoL) questionnaire scores	Baseline to up to 6 months after completion of intervention	The scores for the Smoking Cessation Quality of Life (SCQoL) questionnaire will be evaluated for differences between the pre and post program states using analysis of variance using mixed models to allow for inclusion of all subjects with at least one measurement, with assessment of post-treatment to pre-treatment changes as the primary consideration. Longitudinal repeated measures using linear mixed models will be applied to assess the change from baseline as the outcome, and an exploratory analysis of potential clinical and demographic modifiers will be completed.
Change in Patient Reported Outcomes Measurement Information System (PROMIS) quality of life scores	Baseline to up to 6 months after completion of intervention	The scores for the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire will be evaluated for differences between the pre and post program states using analysis of variance using mixed models to allow for inclusion of all subjects with at least one measurement, with assessment of post-treatment to pre-treatment changes as the primary consideration. Longitudinal repeated measures using linear mixed models will be applied to assess the change from baseline as the outcome, and an exploratory analysis of potential clinical and demographic modifiers will be completed.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States