NCT02591433

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

October 28, 2015

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) quality of life scores

    Baseline to up to 6 months after completion of intervention

  • Change in Smoking Cessation Quality of Life (SCQoL) questionnaire scores

    Baseline to up to 6 months after completion of intervention

Study Arms (1)

Supportive care (JeffQuit group therapy)

EXPERIMENTAL

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.

Other: Tobacco Cessation CounselingOther: Support Group TherapyOther: Quality-of-Life Assessment

Interventions

Undergo JeffQuit group therapy

Also known as: Tobacco Cessation Counseling, Tobacco Counseling
Supportive care (JeffQuit group therapy)

Undergo JeffQuit group therapy

Supportive care (JeffQuit group therapy)

Ancillary studies

Also known as: Quality of Life Assessment, Quality-of-Life Assessment
Supportive care (JeffQuit group therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of cancer
  • Current smoker
  • Willing to provide consent and participate in the JeffQuit program
  • Referral by a Kimmel Cancer Center provider

You may not qualify if:

  • 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)
  • Currently participating in another smoking cessation program
  • Currently receiving chemotherapy or radiation therapy that would interfere with their ability to participate in the JeffQuit program
  • Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
  • Patients with current alcohol or drug abuse
  • Enrollment in active clinical trial/ experimental therapy within the prior 30 days
  • Are in the terminal stages of illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Andrew Newberg, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 29, 2015

Study Start

August 1, 2013

Primary Completion

November 1, 2014

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations