Limited Stage Small Cell Lung CancerPhase 1NCT01457469
Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer
A Phase 1 study testing questionnaire administration, quality-of-life assessment and counseling intervention in people with Limited Stage Small Cell Lung Cancer and Recurrent Small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This randomized clinical trial studies enhanced quitline intervention in smoking cessation for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may help patients with early-stage cancer quit smoking Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer
- What is being tested?
- questionnaire administration, quality-of-life assessment and counseling intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- Phase
- Phase 1
- 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
- Diagnosed with American Joint Committee on Cancer (AJCC) stage I-IIIa/b non-small cell lung cancer or limited stage small cell lung cancer Smoked any cigarettes in the past seven days Willing to consider quitting smoking
Who cannot join
- Patients with drug and alcohol abuse:
- All patients will be assessed for alcohol use using a validated 1-item screening question; if positive, patients will be assessed using the validated Alcohol Use Disorders Identification Test (AUDIT) screening instrument, those with scores >= 8 (the validated cutoff) will be excluded
- All patients will be assessed for drug use using a 1-item screening question: "How many times in the past month have you used an illegal drug or used a prescription medication for non-medical reasons?"; those with a response of >= 1 will be excluded Patient is unable to comprehend study documents and provide informed consent or Eastern Cooperative Oncology Group (ECOG) performance status is greater than two Patient does not read or understand English Patient refuses to participate Patient is contraindicated to receive nicotine replacement therapy: a) Patient is pregnant or breastfeeding, b) Patient has unstable cardiac disease within the past month (defined as unstable angina, myocardial infarction, serious arrhythmias, or any cardiac intervention procedure), or c) Patient is currently taking Chantix Patient does not have regular access to a phone to receive calls from the quitline
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting
This randomized clinical trial studies enhanced quitline intervention in smoking cessation for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may help patients with early-stage cancer quit smoking
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate the feasibility of delivering an enhanced quitline-based smoking cessation intervention to lung cancer patients in the outpatient oncology setting.
SECONDARY OBJECTIVES:
- To gather preliminary outcome data for an enhanced quitline-based smoking cessation intervention adapted to the outpatient oncology setting to support future grant applications.
II. To evaluate change in primary patient reported outcomes, including quality of life (quantified by the Functional Assessment of Cancer Therapy - Lung [FACT-L] and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module [EORTC QLQ LC13]), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the Center for Epidemiological Studies Short Depression Scale [CESD-10]), in lung cancer patients in the intervention and control conditions (control arm closed to accrual as of 3/6/2012) from baseline to 3-months following randomization.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (closed to accrual as of 3/6/2012): Patients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute's "Cleaning the Air" smoking cessation booklet.
ARM II: Patients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program.
After completion of study treatment, patients are followed up at 3 months.
- Conditions
- Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer
- Being tested
- questionnaire administration, quality-of-life assessment, counseling intervention, internet-based intervention, telephone-based intervention
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
counseling interventionOther
Also called counseling and communications studies
Undergo counseling session
internet-based interventionOther
Receive enhanced quitline intervention
telephone-based interventionBehavioural
Receive enhanced quitline intervention
educational interventionOther
Also called intervention, educational
Receive usual care plus
nicotine replacement therapyDrug
Also called Nicotine Replacement, NRT
Receive nicotine replacement patches
educational interventionOther
Also called intervention, educational
Receive enhanced quitline intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual care plus) (closed to accrual as of 3/6/2012) | Active comparator | Patients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute's "Cleaning the Air" smoking cessation booklet. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: educational intervention |
| Arm II (enhanced quitline) | Experimental | Patients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: counseling intervention; Other: internet-based intervention; Behavioral: telephone-based intervention; Drug: nicotine replacement therapy; Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation of patients with lunch cancer in the outpatient oncology setting
Participation rate will be calculated as the proportion of the eligible patients who agree to participate.
Measured: 1 year
Accrual of patients with lung cancer in the outpatient oncology setting
Estimated as the number of patients accrued divided by the number of months of accrual.
Measured: Over 1 year
Participant retention
Estimated as the proportion of participating patients who complete questionnaires at the three month follow-up. Participants who discontinue the intervention but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by intervention arm. A Fisher exact test will be used to assess the difference in retention between the two arms. Kaplan-Meier methods will be used to estimate the time to drop-out, and a logrank test will be used to assess the difference in these distributions between treatment arms.
Measured: 3 months
Participant acceptance of the enhanced quitline-based smoking cessation intervention
Evaluated by summarizing the intervention participants' ratings of how much they liked and found the intervention and the interventionists to be helpful and sensitive to their concerns. Exact 95% confidence intervals (CI) will be calculated for these estimates. Open-ended questions regarding these issues will be summarized using qualitative methods.
Measured: 3 months
Protocol fidelity
Summarized by calculating the proportion of participants in both groups who report that they received advice from their physician to quit smoking, estimating the frequency with which intervention participants completed calls and calculating the mean duration of each call, and calculating the proportion of participants that utilized web-based services (including the frequency of the number of logins and sections visited and mean duration of visit).
Measured: 3 months
Secondary outcomes (2)
Abstinence rate in both groups
Measured: 3 months
Comparison of changes in quality of life, stress, and depressive symptoms between groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Weaver, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457469
- Sponsor's protocol ID
- IRB00014657
- Other IDs
- NCI-2011-02410, CCCWFU 99310
- Status last verified
- Jul 2018
- First submitted
- 21 Oct 2011
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting
- ClinicalTrials.gov ID
- NCT01457469
- Acronym / sponsor ID
- IRB00014657
- Conditions
- Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Oct 2011 (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 randomized clinical trial studies enhanced quitline intervention in smoking cessation for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may help patients with early-stage cancer quit smoking
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate the feasibility of delivering an enhanced quitline-based smoking cessation intervention to lung cancer patients in the outpatient oncology setting.
SECONDARY OBJECTIVES:
- To gather preliminary outcome data for an enhanced quitline-based smoking cessation intervention adapted to the outpatient oncology setting to support future grant applications.
II. To evaluate change in primary patient reported outcomes, including quality of life (quantified by the Functional Assessment of Cancer Therapy - Lung [FACT-L] and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module [EORTC QLQ LC13]), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the Center for Epidemiological Studies Short Depression Scale [CESD-10]), in lung cancer patients in the intervention and control conditions (control arm closed to accrual as of 3/6/2012) from baseline to 3-months following randomization.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (closed to accrual as of 3/6/2012): Patients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute's "Cleaning the Air" smoking cessation booklet.
ARM II: Patients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program.
After completion of study treatment, patients are followed up at 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care plus) (closed to accrual as of 3/6/2012) | Active comparator | Other: questionnaire administration, Procedure: quality-of-life assessment, Other: educational interventionPatients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute's "Cleaning the Air" smoking cessation booklet. |
| Arm II (enhanced quitline) | Experimental | Other: questionnaire administration, Procedure: quality-of-life assessment, Other: counseling intervention, Other: internet-based intervention, Behavioral: telephone-based intervention, Drug: nicotine replacement therapy, Other: educational interventionPatients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with American Joint Committee on Cancer (AJCC) stage I-IIIa/b non-small cell lung cancer or limited stage small cell lung cancer Smoked any cigarettes in the past seven days Willing to consider quitting smoking
Key exclusion criteria (3 listed)
- All patients will be assessed for alcohol use using a validated 1-item screening question; if positive, patients will be assessed using the validated Alcohol Use Disorders Identification Test (AUDIT) screening instrument, those with scores >= 8 (the validated cutoff) will be excluded
- All patients will be assessed for drug use using a 1-item screening question: "How many times in the past month have you used an illegal drug or used a prescription medication for non-medical reasons?"; those with a response of >= 1 will be excluded Patient is unable to comprehend study documents and provide informed consent or Eastern Cooperative Oncology Group (ECOG) performance status is greater than two Patient does not read or understand English Patient refuses to participate Patient is contraindicated to receive nicotine replacement therapy: a) Patient is pregnant or breastfeeding, b) Patient has unstable cardiac disease within the past month (defined as unstable angina, myocardial infarction, serious arrhythmias, or any cardiac intervention procedure), or c) Patient is currently taking Chantix Patient does not have regular access to a phone to receive calls from the quitline
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 |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Arm I (usual care plus) (closed to accrual as of 3/6/2012), Arm II (enhanced quitline) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (usual care plus) (closed to accrual as of 3/6/2012), Arm II (enhanced quitline) |
| counseling interventionAlso: counseling and communications studiesUndergo counseling session | Other | Arm II (enhanced quitline) |
| internet-based interventionReceive enhanced quitline intervention | Other | Arm II (enhanced quitline) |
| telephone-based interventionReceive enhanced quitline intervention | Behavioural | Arm II (enhanced quitline) |
| educational interventionAlso: intervention, educationalReceive usual care plus | Other | Arm I (usual care plus) (closed to accrual as of 3/6/2012) |
| nicotine replacement therapyAlso: Nicotine Replacement, NRTReceive nicotine replacement patches | Drug | Arm II (enhanced quitline) |
| educational interventionAlso: intervention, educationalReceive enhanced quitline intervention | Other | Arm II (enhanced quitline) |
Primary outcome
Participation of patients with lunch cancer in the outpatient oncology setting
Time frame: 1 year
Participation rate will be calculated as the proportion of the eligible patients who agree to participate.
Accrual of patients with lung cancer in the outpatient oncology setting
Time frame: Over 1 year
Estimated as the number of patients accrued divided by the number of months of accrual.
Participant retention
Time frame: 3 months
Estimated as the proportion of participating patients who complete questionnaires at the three month follow-up. Participants who discontinue the intervention but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by intervention arm. A Fisher exact test will be used to assess the difference in retention between the two arms. Kaplan-Meier methods will be used to estimate the time to drop-out, and a logrank test will be used to assess the difference in these distributions between treatment arms.
Participant acceptance of the enhanced quitline-based smoking cessation intervention
Time frame: 3 months
Evaluated by summarizing the intervention participants' ratings of how much they liked and found the intervention and the interventionists to be helpful and sensitive to their concerns. Exact 95% confidence intervals (CI) will be calculated for these estimates. Open-ended questions regarding these issues will be summarized using qualitative methods.
Protocol fidelity
Time frame: 3 months
Summarized by calculating the proportion of participants in both groups who report that they received advice from their physician to quit smoking, estimating the frequency with which intervention participants completed calls and calculating the mean duration of each call, and calculating the proportion of participants that utilized web-based services (including the frequency of the number of logins and sections visited and mean duration of visit).
2 secondary outcomes
Abstinence rate in both groups
Time frame: 3 months
Comparison of changes in quality of life, stress, and depressive symptoms between groups
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
Kathryn Weaver principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing questionnaire administration, quality-of-life assessment and counseling intervention in people with Limited Stage Small Cell Lung Cancer and Recurrent Small Cell Lung Cancer, run by Wake Forest University Health Sciences 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 1 Aug 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participation of patients with lunch cancer in the outpatient oncology setting (time frame: 1 year). The study lists 5 primary outcomes in all. 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 Aug 2018.