Smoking CessationPhase 2NCT03316170
Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
A Phase 2 study testing Social Support and NRT Sampling in people with Smoking Cessation and Social Stress, run by Jessica Burris at 1 site in United States.
Trial summary
The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation, Social Stress
- What is being tested?
- Social Support and NRT Sampling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 31 Mar 2020
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical or head/neck cancer diagnosis in the past 5 years
- Resident of rural and/or Appalachian Kentucky county at cancer diagnosis
- Current smoker of ≥ 10 cigarettes per day, on average
- Age 18-75 years old
- Able to read, write, and understand English
Who cannot join
- Unreliable phone access
- Smoking cessation treatment use in past 30 days
- Non-cigarette tobacco use in the past 30 days
- Any FDA contraindication for NRT use, including: allergy to nicotine patches and/or nicotine lozenges; severe kidney or liver disease; unstable angina or serious arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months
- Cognitive or psychiatric disorder that would interfere with ability to provide informed consent or answer survey questions reliably *
- Any of these Diagnostic and Statistical Manual-5 (DSM-5) cognitive and psychiatric disorders would make someone ineligible: bipolar; delusional; dissociative; intellectual developmental; neurocognitive; psychotic; schizophreniform, schizophrenia, and schizoaffective.
- For women: breastfeeding, pregnancy, or plan to become pregnant within 6 months
- For women of childbearing potential: unwillingness to use an effective method of birth control (e.g., abstinence, oral contraceptive) while in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
About this study
The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation.
Read the detailed description
This is a pilot (Phase II) randomized clinical trial with randomization in a 1:1 ratio. The control group will receive a brief consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs. Additionally, a written directory of a range of social support resources will be delivered to them via mail. The treatment group will receive the aforesaid intervention plus brief advice to quit smoking (10-15 minutes via phone). Additionally, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) will be provided via mail. The treatment group will also receive a free, 2-week supply of nicotine patches and lozenges delivered via mail. As a pilot, this study focuses on the outcomes of feasibility (i.e., accrual and retention) and acceptability (e.g., participants' perceptions of appropriateness and effectiveness) as opposed to efficacy (though this is also important). The emphasis on smoking cessation induction (that is, the inducement or promotion of a quit attempt) is an important aspect of the study design and is appropriate for smokers across the continuum of motivation to quit.
- Conditions
- Smoking Cessation, Social Stress
- Being tested
- Social Support, NRT Sampling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social SupportBehavioural
A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
NRT SamplingDrug
A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
| Study group | Role | What they receive |
|---|---|---|
| Social Support + NRT Sampling | Experimental | The treatment group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail,
3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation,
4. a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and
5. a free, 2-week supply of nicotine patches and lozenges delivered via mail. Receives: Behavioral: Social Support; Drug: NRT Sampling |
| Social Support | Active comparator | The control group will receive:
1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,
2. a written directory of a range of social support resources delivered via mail, Receives: Behavioral: Social Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual Percentage
Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Measured: Day 0 baseline
Retention
Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100
Measured: Through study completion, number of assessments at Day 60 follow-up
Acceptability
Total score on the Treatment Acceptability and Preferences measure (Sidani et al., 2009). This is a 4-item measure with each item scored on a scale from 0 to 4. Total scores are computed as the mean of the 4 individual items, so total scores range from 0 to 4. Higher scores indicate a better outcome, as they reflect greater acceptability of the treatment provided in this clinical trial.
Measured: Day 60 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start6 Nov 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessica Burris
- Sponsor type
- University, hospital or other
- Collaborators
- Kentucky Lung Cancer Research Program
- Responsible party
- Sponsor-investigator, Jessica Burris, University of Kentucky
- Investigators
- Jessica Burris, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316170
- Sponsor's protocol ID
- MCC-17-0495-P3K
- Status last verified
- Jun 2021
- First submitted
- 26 Sep 2017
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.
PubMed 19434647
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
- ClinicalTrials.gov ID
- NCT03316170
- Acronym / sponsor ID
- MCC-17-0495-P3K
- Conditions
- Smoking Cessation, Social Stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Jessica BurrisUniversity, hospital or other
- Collaborators
- Kentucky Lung Cancer Research Program
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation.
Detailed description
This is a pilot (Phase II) randomized clinical trial with randomization in a 1:1 ratio. The control group will receive a brief consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs. Additionally, a written directory of a range of social support resources will be delivered to them via mail. The treatment group will receive the aforesaid intervention plus brief advice to quit smoking (10-15 minutes via phone). Additionally, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) will be provided via mail. The treatment group will also receive a free, 2-week supply of nicotine patches and lozenges delivered via mail. As a pilot, this study focuses on the outcomes of feasibility (i.e., accrual and retention) and acceptability (e.g., participants' perceptions of appropriateness and effectiveness) as opposed to efficacy (though this is also important). The emphasis on smoking cessation induction (that is, the inducement or promotion of a quit attempt) is an important aspect of the study design and is appropriate for smokers across the continuum of motivation to quit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Support + NRT Sampling | Experimental | Behavioral: Social Support, Drug: NRT SamplingThe treatment group will receive: 1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, 2. a written directory of a range of social support resources delivered via mail, 3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation, 4. a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and 5. a free, 2-week supply of nicotine patches and lozenges delivered via mail. |
| Social Support | Active comparator | Behavioral: Social SupportThe control group will receive: 1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, 2. a written directory of a range of social support resources delivered via mail, |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cervical or head/neck cancer diagnosis in the past 5 years
- Resident of rural and/or Appalachian Kentucky county at cancer diagnosis
- Current smoker of ≥ 10 cigarettes per day, on average
- Age 18-75 years old
- Able to read, write, and understand English
Key exclusion criteria (8 listed)
- Unreliable phone access
- Smoking cessation treatment use in past 30 days
- Non-cigarette tobacco use in the past 30 days
- Any FDA contraindication for NRT use, including: allergy to nicotine patches and/or nicotine lozenges; severe kidney or liver disease; unstable angina or serious arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months
- Cognitive or psychiatric disorder that would interfere with ability to provide informed consent or answer survey questions reliably *
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 |
|---|---|---|
| Social SupportA brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail. | Behavioural | Social Support, Social Support + NRT Sampling |
| NRT SamplingA brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail. | Drug | Social Support + NRT Sampling |
Primary outcome
Accrual Percentage
Time frame: Day 0 baseline
Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Retention
Time frame: Through study completion, number of assessments at Day 60 follow-up
Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100
Acceptability
Time frame: Day 60 follow-up
Total score on the Treatment Acceptability and Preferences measure (Sidani et al., 2009). This is a 4-item measure with each item scored on a scale from 0 to 4. Total scores are computed as the mean of the 4 individual items, so total scores range from 0 to 4. Higher scores indicate a better outcome, as they reflect greater acceptability of the treatment provided in this clinical trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19434647Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.
- Individual participant dataSharing planned: No
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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.
Jessica Burris, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Social Support and NRT Sampling in people with Smoking Cessation and Social Stress, run by Jessica Burris 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 5 inclusion and 8 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 8 Jul 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Jul 2021). 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?
Accrual Percentage (time frame: Day 0 baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03316170, which also lists 1 linked publication.
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 8 Jul 2021.