Lung CancerEarly Phase 1NCT01434342
Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
A Early Phase 1 study testing Nicotine Replacement Patch in people with Lung Cancer and Tobacco Use Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Continued smoking after a cancer diagnosis has important health consequences beyond the risks associated with smoking in the general population. Smoking reduces the efficacy of cancer treatments including surgery, radiation and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Tobacco Use Disorder, Breast Cancer
- What is being tested?
- Nicotine Replacement Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2011to 1 Jan 2015
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- AJCC Stages 0, I, II, \& III lung, breast, prostate, colorectal, bladder, head \& neck, and cervical cancers (all histologies).
- Reports smoking any amount in the last 7 days.
- Scheduled to receive or currently receiving surgery, radiation or chemotherapy OR have received one or more of the following in the last 6 months surgery, last radiation treatment or last chemotherapy treatment.
- 18 years of age or older
- KPS of 70-100
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to consider quitting smoking
Who cannot join
- Unstable cardiac disease - defined as congestive heart failure, unstable angina, serious arrhythmias, or Myocardial Infarction in the past month.
- Current use or planned use of varenicline (Chantix), Zyban, Buproprion or any other nicotinic receptor agonist (Patients that discontinue use of these type drugs within 7 days are eligible.)
- Current probable alcohol abuse as defined by more than 5 drinks per day for men and 4 drinks per day for women and a Alcohol Use Disorders Identification Test (AUDIT) score > 8.
- If patient answers "no" to 5 drinks per day for men and 4 drinks per day for women the patient is eligible. AUDIT assessment does not need to be administered.
- If patient answers "yes " to 5 drinks per day for men and 4 drinks per day for women the AUDIT assessment must be administered. If AUDIT score is > 8 patient is not eligible.
- Use of illegal drugs or use of prescription medications for non-medical reasons in the past month.
Show all 14Show fewer
- Current use of chewing, dipping and pipe tobacco, or cigars.
- Patient does not have regular access to a telephone to receive Quitline calls lasting 15-30 minutes.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nicotine replacement therapy.
- Active Peptic Ulcer Disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing, psychiatric illness/social situations that would limit compliance with study requirements.
- Due to unknown risks and potential harm to the unborn fetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. We encourage you to discuss this issue further with your doctors if you have any questions.
- If you are pregnant, should become pregnant or suspect you are pregnant prior to or while participating in this study, you should inform your study physician immediately. Nicotine replacement therapy has the potential for teratogenic or abortifacient effects and is classified as a FDA Pregnancy category D drug. The U.S. Clinical Practice Guideline states that pregnant smokers should be encouraged to quit without medication based on insufficient evidence of effectiveness and hypothetical concerns with safety. Pregnant women enrolled in the study and randomized to the Quitline group intervention should participate in the Quitline intervention but not receive the nicotine replacement therapy.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nicotine replacement therapy, breastfeeding women are excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
W F Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Lung Cancer Patients Receiving Outpatient Treatment: A Pilot Study
RATIONALE: Continued smoking after a cancer diagnosis has important health consequences beyond the risks associated with smoking in the general population. Smoking reduces the efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the negative consequences, it is estimated that between 15-75% of patients with cancer continue to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head \& neck, and cervical cancer patients were chosen because there is evidence of potential clinical benefit associated with quitting smoking in all of these populations and they represent a mix of both smoking and non-smoking related cancers.
Read the detailed description
OBJECTIVES:
Primary
- To assess the feasibility of delivering a Quitline based smoking cessation intervention to cancer patients in an outpatient setting. To achieve this, we will deliver the intervention to cancer patients in the surgery, radiation and medical oncology departments of participating Community Clinical Oncology Program (CCOP) sites. Following the intervention, we will assess participant, CRA (Clinical Research Associate) Counselor and Quitline staff ratings of acceptability, resources required to deliver the intervention, protocol fidelity, and participant recruitment, retention and adherence.
Secondary
- To obtain a preliminary estimate of the quit rate (as defined by 7-day point-prevalence abstinence) in intervention and control groups. To accomplish this aim, following the intervention we will collect confirmed smoking status data for intervention and control subjects. We will also obtain a preliminary estimate of the treatment effect (difference in quit rates between the two groups) and the standard deviation to better determine the sample size for a future trial.
- To evaluate primary patient reported outcomes, including quality of life (quantified by the FACT-G and for lung cancer patients only the FACT-L other concerns questions and the EORTC QLQ LC13), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the CESD-10), in cancer patients in the intervention and control groups.
- To refine the recruitment and intervention protocols using data collected from participants, Clinical Research Associate (CRA) Counselor, and Quitline staff to increase acceptability and improve retention in future trials.
OUTLINE: This is a multicenter study. Participants are stratified according to time since diagnosis (< 3 months vs ≥ 3 months), treatment status (ongoing vs completed), and cigarette smoking (≤ 10 per day vs ≥ 11 per day). Patients are randomized to 1 of 2 intervention arms.
- Arm I (intervention): Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. During the counseling session, participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues such as managing the stressors associated with cancer diagnosis and treatment. They are also told to expect a call from the Quitline in 2-3 days and receive a fact sheet about benefits of smoking cessation for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Calls are scheduled at convenient times for the participants and at relapse-sensitive intervals including; an initial planning and assessment call, a quit date call, a follow-up call 7 days after the participant's quit date, and 2 additional calls at 2-3-week intervals. Participants are also encouraged to utilize the Quit for Life Web Coach, an interactive web program application that guides them to build online quit plans, set quit dates, and track their progress toward quitting. Participants also learn behavioral tips and coping skills by interacting with others in topic-based discussion forums and community support programs.
- Arm II (standard of care): Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
Participants on the intervention arm complete the Smoking Assessment, Smoking Cessation Self-Efficacy, the Brief Smoking Consequences, the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire LC-13, the Perceived Stress Scale, the Center for Epidemiologic Studies Short Depression Scale (CESD-10 Depression), and the Follow up Smoking Assessment questionnaires at baseline and at 6, 12, and 24 weeks.
Participants, on the intervention arm, undergo saliva sample collection at baseline and at 12 and 24 weeks for cotinine level analysis.
- Being tested
- Nicotine Replacement Patch
- Keywords
- 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, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, limited stage small cell lung cancer, tobacco use disorder, Breast Cancer, Cervical Cancer, head & neck cancer, Prostate Cancer, All histologies
- Medical subject headings
- Lung Neoplasms, Tobacco Use Disorder, Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement PatchDrug
Also called Nicotine patch, Habitrol patch
Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 weeks after the date of the in-person intervention (for Quitline Intervention group) or the provision of the physician letter (for the Usual Care Plus group).
| Study group | Role | What they receive |
|---|---|---|
| Arm I - Quitline | Experimental | Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.
The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.
Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.
Participants also learn behavioral tips and coping skills. Receives: Drug: Nicotine Replacement Patch |
| Arm II - Usual Care | No intervention | Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a Smoking Cessation Intervention Among Cancer Patients
The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.
Measured: 24 Weeks
Adherence
Adherence is measured by the percentage of randomized participants who have a Quitline call. Note that this outcome is only defined for the Intervention arm
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study start1 Oct 2011
- Primary completion1 Jun 2014
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 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, PhD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434342
- Sponsor's protocol ID
- IRB000019384
- Other IDs
- U10CA081851, REBACCCWFU 99211
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2011
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Lung Cancer Patients Receiving Outpatient Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT01434342
- Acronym / sponsor ID
- IRB000019384
- Keywords
- 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, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, limited stage small cell lung cancer, tobacco use disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Continued smoking after a cancer diagnosis has important health consequences beyond the risks associated with smoking in the general population. Smoking reduces the efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the negative consequences, it is estimated that between 15-75% of patients with cancer continue to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head \& neck, and cervical cancer patients were chosen because there is evidence of potential clinical benefit associated with quitting smoking in all of these populations and they represent a mix of both smoking and non-smoking related cancers.
Detailed description
OBJECTIVES:
Primary
- To assess the feasibility of delivering a Quitline based smoking cessation intervention to cancer patients in an outpatient setting. To achieve this, we will deliver the intervention to cancer patients in the surgery, radiation and medical oncology departments of participating Community Clinical Oncology Program (CCOP) sites. Following the intervention, we will assess participant, CRA (Clinical Research Associate) Counselor and Quitline staff ratings of acceptability, resources required to deliver the intervention, protocol fidelity, and participant recruitment, retention and adherence.
Secondary
- To obtain a preliminary estimate of the quit rate (as defined by 7-day point-prevalence abstinence) in intervention and control groups. To accomplish this aim, following the intervention we will collect confirmed smoking status data for intervention and control subjects. We will also obtain a preliminary estimate of the treatment effect (difference in quit rates between the two groups) and the standard deviation to better determine the sample size for a future trial.
- To evaluate primary patient reported outcomes, including quality of life (quantified by the FACT-G and for lung cancer patients only the FACT-L other concerns questions and the EORTC QLQ LC13), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the CESD-10), in cancer patients in the intervention and control groups.
- To refine the recruitment and intervention protocols using data collected from participants, Clinical Research Associate (CRA) Counselor, and Quitline staff to increase acceptability and improve retention in future trials.
OUTLINE: This is a multicenter study. Participants are stratified according to time since diagnosis (< 3 months vs ≥ 3 months), treatment status (ongoing vs completed), and cigarette smoking (≤ 10 per day vs ≥ 11 per day). Patients are randomized to 1 of 2 intervention arms.
- Arm I (intervention): Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. During the counseling session, participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues such as managing the stressors associated with cancer diagnosis and treatment. They are also told to expect a call from the Quitline in 2-3 days and receive a fact sheet about benefits of smoking cessation for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Calls are scheduled at convenient times for the participants and at relapse-sensitive intervals including; an initial planning and assessment call, a quit date call, a follow-up call 7 days after the participant's quit date, and 2 additional calls at 2-3-week intervals. Participants are also encouraged to utilize the Quit for Life Web Coach, an interactive web program application that guides them to build online quit plans, set quit dates, and track their progress toward quitting. Participants also learn behavioral tips and coping skills by interacting with others in topic-based discussion forums and community support programs.
- Arm II (standard of care): Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
Participants on the intervention arm complete the Smoking Assessment, Smoking Cessation Self-Efficacy, the Brief Smoking Consequences, the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire LC-13, the Perceived Stress Scale, the Center for Epidemiologic Studies Short Depression Scale (CESD-10 Depression), and the Follow up Smoking Assessment questionnaires at baseline and at 6, 12, and 24 weeks.
Participants, on the intervention arm, undergo saliva sample collection at baseline and at 12 and 24 weeks for cotinine level analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I - Quitline | Experimental | Drug: Nicotine Replacement PatchParticipants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills. |
| Arm II - Usual Care | No intervention | –Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- AJCC Stages 0, I, II, \& III lung, breast, prostate, colorectal, bladder, head \& neck, and cervical cancers (all histologies).
- Reports smoking any amount in the last 7 days.
- Scheduled to receive or currently receiving surgery, radiation or chemotherapy OR have received one or more of the following in the last 6 months surgery, last radiation treatment or last chemotherapy treatment.
- 18 years of age or older
- KPS of 70-100
Key exclusion criteria (14 listed)
- Unstable cardiac disease - defined as congestive heart failure, unstable angina, serious arrhythmias, or Myocardial Infarction in the past month.
- Current use or planned use of varenicline (Chantix), Zyban, Buproprion or any other nicotinic receptor agonist (Patients that discontinue use of these type drugs within 7 days are eligible.)
- Current probable alcohol abuse as defined by more than 5 drinks per day for men and 4 drinks per day for women and a Alcohol Use Disorders Identification Test (AUDIT) score > 8.
- If patient answers "no" to 5 drinks per day for men and 4 drinks per day for women the patient is eligible. AUDIT assessment does not need to be administered.
- If patient answers "yes " to 5 drinks per day for men and 4 drinks per day for women the AUDIT assessment must be administered. If AUDIT score is > 8 patient is not eligible.
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 |
|---|---|---|
| Nicotine Replacement PatchAlso: Nicotine patch, Habitrol patchStudy participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 weeks after the date of the in-person intervention (for Quitline Intervention group) or the provision of the physician letter (for the Usual Care Plus group). | Drug | Arm I - Quitline |
Primary outcome
Feasibility of a Smoking Cessation Intervention Among Cancer Patients
Time frame: 24 Weeks
The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.
Adherence
Time frame: 24 weeks
Adherence is measured by the percentage of randomized participants who have a Quitline call. Note that this outcome is only defined for the Intervention arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Quitline Based Smoking CessationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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, PhD, MPH 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 Early Phase 1 study testing Nicotine Replacement Patch in people with Lung Cancer and Tobacco Use Disorder, 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 7 inclusion and 14 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 28 Sep 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of a Smoking Cessation Intervention Among Cancer Patients (time frame: 24 Weeks). The study lists 2 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 28 Sep 2021.