Smoking Cessation, Social Stress
Conditions
Brief 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.
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.
Interventions
BEHAVIORALSocial 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.
DRUGNRT 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.
Sponsors
Kentucky Lung Cancer Research Program
Jessica Burris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual Percentage | Day 0 baseline | Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100 |
| Retention | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Social Support + NRT Sampling 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.
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. | 24 |
| Social Support 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,
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. | 25 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 7 |
Baseline characteristics
| Characteristic | Social Support + NRT Sampling | Social Support | Total |
|---|---|---|---|
| Age, Continuous | 54.78 years STANDARD_DEVIATION 9.27 | 56.00 years STANDARD_DEVIATION 10 | 55.42 years STANDARD_DEVIATION 9.58 |
| Distress Thermometer (NCCN) | 4.21 units on a scale STANDARD_DEVIATION 2.95 | 4.72 units on a scale STANDARD_DEVIATION 3.45 | 4.47 units on a scale STANDARD_DEVIATION 3.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 25 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 23 Participants | 45 Participants |
| Region of Enrollment United States | 24 Participants | 25 Participants | 49 Participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 24 | 0 / 25 |
| other Total, other adverse events | 8 / 24 | 10 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
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.
Time frame: Day 60 follow-up
Population: Analysis based on participants who completed the Day 60 assessment and provided data for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Individuals Contacted | Acceptability | 2.84 score on a scale | Standard Deviation 1.09 |
| Social Support | Acceptability | 1.98 score on a scale | Standard Deviation 1.38 |
p-value: 0.0695% CI: [-1.75, 0.3]t-test, 2 sided
Primary
Accrual Percentage
Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Time frame: Day 0 baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Individuals Contacted | Accrual Percentage | 8.9 percentage of participants enrolled |
Primary
Retention
Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100
Time frame: Through study completion, number of assessments at Day 60 follow-up
Population: Participants enrolled in the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Individuals Contacted | Retention | 70.8 percentage of participant w/ assessments |
| Social Support | Retention | 72.0 percentage of participant w/ assessments |