Clinical trial NCT02591433: JeffQuit Group Therapy Program for Smoking Cessation in Patients With a History of Cancer
Official title: Pilot Study of the Effectiveness of the JeffQuit Smoking Cessation Program
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Current Smoker
Malignant Neoplasm
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who are adherent to smoking abstinence
timeFrame: Up to 6 months after completion of intervention
Secondary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) quality of life scores
timeFrame: Baseline to up to 6 months after completion of intervention
measure: Change in Smoking Cessation Quality of Life (SCQoL) questionnaire scores
timeFrame: Baseline to up to 6 months after completion of intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Andrew Newberg, MD
role: PRINCIPAL_INVESTIGATOR
References: