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| Name | Class |
|---|---|
| Kentucky Lung Cancer Research Program | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Support + NRT Sampling | Experimental | The treatment group will receive:
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| Social Support | Active Comparator | The control group will receive:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accrual Percentage | Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100 | Day 0 baseline |
| Retention | Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100 | 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. | Day 60 follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Burris, Ph.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19434647 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Social Support + NRT Sampling | The treatment group will receive:
Social Support: 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 Sampling: 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. |
| FG001 | Social Support | The control group will receive:
Social Support: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Each participant is 1 unit in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Social Support + NRT Sampling | The treatment group will receive:
Social Support: 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 Sampling: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 participant did not report their age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accrual Percentage | Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100 | Across all recruitment methods, a total of 551 individuals were contacted about the study; this number is not tied to study arm. Of these 551 individuals, a subset met the eligibility criteria, enrolled in the study, and were then randomized into one of the study arms. | Posted | Number | percentage of participants enrolled | Day 0 baseline |
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Approximately 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Social Support + NRT Sampling | The treatment group will receive:
Social Support: 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 Sampling: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breathing difficulty | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Burris | University of Kentucky | +1 859-257-9612 | jessica.burris@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2021 | Mar 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| NRT Sampling | Drug | 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. |
|
| BG001 | Social Support | The control group will receive:
Social Support: 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Distress Thermometer (NCCN) | The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a single-item measure of overall distress where people respond on a 11-point scale from 0 to 10. Higher scores indicate a worse outcome, as they reflect more distress. | Mean | Standard Deviation | units on a scale |
|
| Participants |
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| Primary | Retention | Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100 | Participants enrolled in the study | Posted | Number | percentage of participant w/ assessments | Through study completion, number of assessments at Day 60 follow-up |
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| Primary | 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. | Analysis based on participants who completed the Day 60 assessment and provided data for this outcome | Posted | Mean | Standard Deviation | score on a scale | Day 60 follow-up |
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| 1 |
| 24 |
| 0 |
| 24 |
| 8 |
| 24 |
| EG001 | Social Support | The control group will receive:
Social Support: 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. | 0 | 25 | 0 | 25 | 10 | 25 |
| Burning in throat or mouth | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Dry mouth | General disorders | Systematic Assessment |
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| Excessive saliva | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Hiccups | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Irregular heartbeat | Cardiac disorders | Systematic Assessment |
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| Rapid heartbeat | Cardiac disorders | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sore mouth | General disorders | Systematic Assessment |
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| Sore throat | General disorders | Systematic Assessment |
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| Vomiting or nausea | Gastrointestinal disorders | Systematic Assessment |
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| Weakness | General disorders | Systematic Assessment |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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