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

Malignant Neoplasm Clinical Trial

Official title:

Pilot Study of the Effectiveness of the JeffQuit Smoking Cessation Program

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02591433
• Other study ID #: 13D.423
• Status: Withdrawn
• Phase: N/A
• First received: October 28, 2015
• Last updated: October 18, 2016
• Start date: August 2013

Study information

• Verified date: October 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Current Smoker
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Tobacco Cessation Counseling
Undergo JeffQuit group therapy
• Support Group Therapy
Undergo JeffQuit group therapy
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who are adherent to smoking abstinence	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%.	Up to 6 months after completion of intervention	No
Secondary	Change in Patient Reported Outcomes Measurement Information System (PROMIS) quality of life scores	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.	Baseline to up to 6 months after completion of intervention	No
Secondary	Change in Smoking Cessation Quality of Life (SCQoL) questionnaire scores	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.	Baseline to up to 6 months after completion of intervention	No

External Links

•   Jefferson University Hospitals