Malignant NeoplasmNCT02211196
Evidence-Based Tobacco Cessation Strategies in Patients With Cancer
A study testing smoking cessation intervention, survey administration and questionnaire administration in people with Malignant Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot clinical trial studies evidence-based tobacco cessation strategies in patients with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit smoking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- smoking cessation intervention, survey administration and questionnaire administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with cancer who saw a provider will be eligible
Who cannot join
- Having a nurse or lab visit only
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Implementing Evidence-Based Tobacco Cessation Strategies in Oncology Clinics
This pilot clinical trial studies evidence-based tobacco cessation strategies in patients with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit smoking.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess oncology providers' self-reported need for training on evidence-based tobacco cessation strategies and assess their level of interest in future training on evidence-based tobacco cessation strategies.
II. To test the feasibility of the implementation of evidence-based tobacco cessation strategies in community oncology clinics.
III. To test the feasibility of surveying community oncology patients after a clinic visit to assess provider behavior regarding screening and brief intervention for tobacco use.
OUTLINE:
Patients complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.
After completion of study, patients are followed up at 1 month.
- Conditions
- Malignant Neoplasm
- Being tested
- smoking cessation intervention, survey administration, questionnaire administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation interventionBehavioural
Receive evidence-based tobacco cessation strategies
survey administrationOther
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health Services Research (smoking cessation intervention) | Experimental | Participants complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting. Receives: Behavioral: smoking cessation intervention; Other: survey administration; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of providers from the Piedmont Oncology Association (POA) reporting a need for training on evidence-based tobacco cessation strategies
Will be estimated and 95% confidence intervals (CI) constructed.
Measured: Up to 1 month
Percentage reporting feeling very confident in their ability to counsel smokers
Will be estimated and 95% CI constructed.
Measured: Up to 1 month
Percentage reporting they would be willing to participate in training on evidence-based tobacco cessation strategies
Will be estimated and 95% CI constructed.
Measured: Up to 1 month
Proportion of oncology patients willing to complete a survey in an oncology clinic
Will be estimated and 95% CI constructed.
Measured: Up to 1 month
Proportion of patients who report that their provider asked about tobacco use during their visit
These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.
Measured: Up to 1 month
Proportion of current smokers who report that their provider advised them to quit during their visit and provided tobacco-cessation strategies
These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 377 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
- Erin Sutfin, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211196
- Sponsor's protocol ID
- IRB00021885
- Other IDs
- NCI-2014-01572, CCCWFU #99413, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 5 Aug 2014
- Last updated
- 3 Jul 2018
- 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 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Evidence-Based Tobacco Cessation Strategies in Oncology Clinics
- ClinicalTrials.gov ID
- NCT02211196
- Acronym / sponsor ID
- IRB00021885
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Aug 2014 (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 evidence-based tobacco cessation strategies in patients with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit smoking.
Detailed description
PRIMARY OBJECTIVES:
- To assess oncology providers' self-reported need for training on evidence-based tobacco cessation strategies and assess their level of interest in future training on evidence-based tobacco cessation strategies.
II. To test the feasibility of the implementation of evidence-based tobacco cessation strategies in community oncology clinics.
III. To test the feasibility of surveying community oncology patients after a clinic visit to assess provider behavior regarding screening and brief intervention for tobacco use.
OUTLINE:
Patients complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.
After completion of study, patients are followed up at 1 month.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (smoking cessation intervention) | Experimental | Behavioral: smoking cessation intervention, Other: survey administration, Other: questionnaire administrationParticipants complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with cancer who saw a provider will be eligible
Key exclusion criteria (1 listed)
- Having a nurse or lab visit only
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 cessation interventionReceive evidence-based tobacco cessation strategies | Behavioural | Health Services Research (smoking cessation intervention) |
| survey administrationAncillary studies | Other | Health Services Research (smoking cessation intervention) |
| questionnaire administrationAncillary studies | Other | Health Services Research (smoking cessation intervention) |
Primary outcome
Percentage of providers from the Piedmont Oncology Association (POA) reporting a need for training on evidence-based tobacco cessation strategies
Time frame: Up to 1 month
Will be estimated and 95% confidence intervals (CI) constructed.
Percentage reporting feeling very confident in their ability to counsel smokers
Time frame: Up to 1 month
Will be estimated and 95% CI constructed.
Percentage reporting they would be willing to participate in training on evidence-based tobacco cessation strategies
Time frame: Up to 1 month
Will be estimated and 95% CI constructed.
Proportion of oncology patients willing to complete a survey in an oncology clinic
Time frame: Up to 1 month
Will be estimated and 95% CI constructed.
Proportion of patients who report that their provider asked about tobacco use during their visit
Time frame: Up to 1 month
These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.
Proportion of current smokers who report that their provider advised them to quit during their visit and provided tobacco-cessation strategies
Time frame: Up to 1 month
These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.
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 3 Jul 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.
Erin Sutfin 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 study testing smoking cessation intervention, survey administration and questionnaire administration in people with Malignant Neoplasm, 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 1 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 3 Jul 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.
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?
Percentage of providers from the Piedmont Oncology Association (POA) reporting a need for training on evidence-based tobacco cessation strategies (time frame: Up to 1 month). The study lists 6 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 3 Jul 2018.