Smoking CessationNCT05107687
Effectiveness of Smoking Cessation Program in a Community Health System
An observational study of Smoking Cessation, run by Virtua Health, Inc. at 1 site in United States.
Trial summary
Research efforts are needed to increase tobacco cessation support and to improve tobacco cessation efficacy. In addition, strategies must be identified to increase access to smoking cessation support and to develop processes to integrate smoking cessation into treatment plans for cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 30 Dec 2025
- Phase
- Observational
- 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
Study population: All cancer patients who are actively smoking receiving treatment for any type of cancer, for patients who have completed treatment and cancer survivors.
Who may be able to join
- Any Gender
- Over 18 years of age
- Able to read and understand English
- Able to sign the informed consent form
- A current cigarette smoker defined as smoking within 30 days
- Diagnosed with cancer and wants to quit smoking
Who cannot join
- • Individuals with Dementia
- ECOG Performance Status 3-4
- Survival prognosis less than 12 months
- Currently participating in a smoking cessation program that is not provided by Virtua
- Individuals who do not want to quit smoking
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Structured Smoking Cessation Program Versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System
Research efforts are needed to increase tobacco cessation support and to improve tobacco cessation efficacy. In addition, strategies must be identified to increase access to smoking cessation support and to develop processes to integrate smoking cessation into treatment plans for cancer patients.
Read the detailed description
The Cancer Patient Tobacco Questionnaire (C-TUQ) survey tool will be used to address the primary and secondary outcome measures. This tool is publicly available on the National Cancer Institutes Grid-Enabled Measures website and was developed by NCI and the American Association for Cancer Research. This tool is a 22-item self-report survey designed to capture information about tobacco use by cancer patients and cancer survivors. Comparisons will be made for those patients that enroll in the structured smoking cessation program versus those patients that have opted to quit on their own.
Primary:
To determine the effectiveness of an intensive structured smoking cessation program (education and support) provided by a tobacco cessation trained specialist versus unassisted smoking cessation quitting methods (no support, patients have opted to stop on their own) in cancer patients seen in a community health care system
Secondary:
- Self-reported 7-day point-prevalence smoking abstinence at 6-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking with professional support
- Self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking without professional support, participants choosing to stop smoking on their own.
- Examine the impact of implementing a system level smoking cessation program into the ongoing management of our cancer patients who smoke.
- Conditions
- Smoking Cessation
- Being tested
- Smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessationBehavioural
Assisted Smoking Cessation- Subject is provided professional support provided by tobacco cessation specialist.
Unassisted Smoking Cessation- Subject provided resources and attempts to quit smoking without professional support.
The subject selects their preferred intervention.
| Study group | Role | What they receive |
|---|---|---|
| Assisted Smoking Cessation | Subject participates in a structured smoking cessation program hosted at Virtua Health which may be either smoking cessation group sessions or individual sessions and/or both. All participants will be provided with a list of smoking cessation resources.
Description of Group Smoking Education and Support: These sessions are led by a Tobacco Treatment Specialist and include 2-3 sessions in-person or virtually and cover the following topics: Biological changes caused by nicotine, addiction, tips to quit smoking, health benefits to quitting smoking, types of nicotine replacement therapy, e-cigarettes and devices, aromatherapy, meditation and various resources. In addition, access to nicotine replacement therapies is optional. Receives: Behavioral: Smoking cessation | |
| Unassisted Smoking Cessation | The subject receives no professional support but is provided with a list of smoking cessation resources, in this cohort the subject engages in smoking cessation with no assistance from a provider. Receives: Behavioral: Smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System
To determine the effectiveness of an intensive structured smoking cessation program versus unassisted smoking cessation quitting methods in cancer patients seen in a community health care system
Measured: 6 and 12 month intervals
Secondary outcomes (1)
The Effectiveness of a Structured Smoking Cessation Program in Cancer Patients in a Community Health System The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessatio
- Self-reported 7-day point-prevalence smoking abstinence at 6-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking without professional support.
- Self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking without professional support.
- Examine the impact of implementing a system level smoking cessation program into the ongoing management of our cancer patients who smoke.
Measured: 6 and 12 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start10 May 2021
- Primary completion31 May 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virtua Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theresa Carducci, MSN, RN, CCRP, Principal investigator, Virtua Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107687
- Sponsor's protocol ID
- IRB-2021-02
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2021
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Structured Smoking Cessation Program Versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System
- ClinicalTrials.gov ID
- NCT05107687
- Acronym / sponsor ID
- IRB-2021-02
- Conditions
- Smoking Cessation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Virtua Health, Inc.University, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Nov 2021 (actual)
- 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.
Research efforts are needed to increase tobacco cessation support and to improve tobacco cessation efficacy. In addition, strategies must be identified to increase access to smoking cessation support and to develop processes to integrate smoking cessation into treatment plans for cancer patients.
Detailed description
The Cancer Patient Tobacco Questionnaire (C-TUQ) survey tool will be used to address the primary and secondary outcome measures. This tool is publicly available on the National Cancer Institutes Grid-Enabled Measures website and was developed by NCI and the American Association for Cancer Research. This tool is a 22-item self-report survey designed to capture information about tobacco use by cancer patients and cancer survivors. Comparisons will be made for those patients that enroll in the structured smoking cessation program versus those patients that have opted to quit on their own.
Primary:
To determine the effectiveness of an intensive structured smoking cessation program (education and support) provided by a tobacco cessation trained specialist versus unassisted smoking cessation quitting methods (no support, patients have opted to stop on their own) in cancer patients seen in a community health care system
Secondary:
- Self-reported 7-day point-prevalence smoking abstinence at 6-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking with professional support
- Self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking without professional support, participants choosing to stop smoking on their own.
- Examine the impact of implementing a system level smoking cessation program into the ongoing management of our cancer patients who smoke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted Smoking Cessation | – | Behavioral: Smoking cessationSubject participates in a structured smoking cessation program hosted at Virtua Health which may be either smoking cessation group sessions or individual sessions and/or both. All participants will be provided with a list of smoking cessation resources. Description of Group Smoking Education and Support: These sessions are led by a Tobacco Treatment Specialist and include 2-3 sessions in-person or virtually and cover the following topics: Biological changes caused by nicotine, addiction, tips to quit smoking, health benefits to quitting smoking, types of nicotine replacement therapy, e-cigarettes and devices, aromatherapy, meditation and various resources. In addition, access to nicotine replacement therapies is optional. |
| Unassisted Smoking Cessation | – | Behavioral: Smoking cessationThe subject receives no professional support but is provided with a list of smoking cessation resources, in this cohort the subject engages in smoking cessation with no assistance from a provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cancer patients who are actively smoking receiving treatment for any type of cancer, for patients who have completed treatment and cancer survivors.
Key inclusion criteria (6 listed)
- Any Gender
- Over 18 years of age
- Able to read and understand English
- Able to sign the informed consent form
- A current cigarette smoker defined as smoking within 30 days
Key exclusion criteria (6 listed)
- • Individuals with Dementia
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 |
|---|---|---|
| Smoking cessationAssisted Smoking Cessation- Subject is provided professional support provided by tobacco cessation specialist. Unassisted Smoking Cessation- Subject provided resources and attempts to quit smoking without professional support. The subject selects their preferred intervention. | Behavioural | Assisted Smoking Cessation, Unassisted Smoking Cessation |
Primary outcome
The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System
Time frame: 6 and 12 month intervals
To determine the effectiveness of an intensive structured smoking cessation program versus unassisted smoking cessation quitting methods in cancer patients seen in a community health care system
1 secondary outcome
The Effectiveness of a Structured Smoking Cessation Program in Cancer Patients in a Community Health System The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessatio
Time frame: 6 and 12 month intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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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.
Theresa Carducci, MSN, RN, CCRP principal investigator
Virtua Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by Virtua Health, Inc. 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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?
Results are not available in the source record.
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?
The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System (time frame: 6 and 12 month intervals). 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 5 Apr 2024.