Current SmokerNCT02591433
JeffQuit Group Therapy Program for Smoking Cessation in Patients With a History of Cancer
A study testing Tobacco Cessation Counseling, Support Group Therapy and Quality-of-Life Assessment in people with Current Smoker and Malignant Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Current Smoker, Malignant Neoplasm
- What is being tested?
- Tobacco Cessation Counseling, Support Group Therapy and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of cancer
- Current smoker
- Willing to provide consent and participate in the JeffQuit program
- Referral by a Kimmel Cancer Center provider
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Pilot Study of the Effectiveness of the JeffQuit Smoking Cessation Program
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Current Smoker, Malignant Neoplasm
- Being tested
- Tobacco Cessation Counseling, Support Group Therapy, Quality-of-Life Assessment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco Cessation CounselingOther
Also called Tobacco Cessation Counseling, Tobacco Counseling
Undergo JeffQuit group therapy
Support Group TherapyOther
Undergo JeffQuit group therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment, Quality-of-Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tobacco Cessation Counseling; Other: Support Group Therapy; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Up to 6 months after completion of intervention
Secondary outcomes (2)
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.
Measured: Baseline to up to 6 months after completion of intervention
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.
Measured: Baseline to up to 6 months after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startAug 2013
- Primary completionNov 2014
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Current SmokerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Newberg, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591433
- Sponsor's protocol ID
- 13D.423
- Other IDs
- JT 2686
- Status last verified
- Apr 2025
- First submitted
- 28 Oct 2015
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effectiveness of the JeffQuit Smoking Cessation Program
- ClinicalTrials.gov ID
- NCT02591433
- Acronym / sponsor ID
- 13D.423
- Conditions
- Current Smoker, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow Accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (JeffQuit group therapy) | Experimental | Other: Tobacco Cessation Counseling, Other: Support Group Therapy, Other: Quality-of-Life AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of cancer
- Current smoker
- Willing to provide consent and participate in the JeffQuit program
- Referral by a Kimmel Cancer Center provider
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco Cessation CounselingAlso: Tobacco Cessation Counseling, Tobacco CounselingUndergo JeffQuit group therapy | Other | Supportive care (JeffQuit group therapy) |
| Support Group TherapyUndergo JeffQuit group therapy | Other | Supportive care (JeffQuit group therapy) |
| Quality-of-Life AssessmentAlso: Quality of Life Assessment, Quality-of-Life AssessmentAncillary studies | Other | Supportive care (JeffQuit group therapy) |
Primary outcome
Proportion of patients who are adherent to smoking abstinence
Time frame: 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%.
2 secondary outcomes
Change in Patient Reported Outcomes Measurement Information System (PROMIS) quality of life scores
Time frame: Baseline to up to 6 months after completion of intervention
Change in Smoking Cessation Quality of Life (SCQoL) questionnaire scores
Time frame: Baseline to up to 6 months after completion of intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Jefferson University HospitalsLink provided by the sponsor.
Related trials for Current Smoker
RecruitingPhase 2
A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers
Smoking Cessation, Nicotine Replacements Therapy
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Active, not recruiting
Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer
Lung Carcinoma
Active, not recruiting
Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment
Depression, Tobacco Use Disorder
Recruiting
Vaped Phenanthrene
Former Smoker, Non-Smoker
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Newberg, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco Cessation Counseling, Support Group Therapy and Quality-of-Life Assessment in people with Current Smoker and Malignant Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are adherent to smoking abstinence (time frame: Up to 6 months after completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.