Clinical trial NCT03316170
Conditions: Smoking Cessation Social Stress
Sponsor: Jessica Burris
Start date: 2017-11-06; Completion date: 2020-03-31
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: 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,
Interventions: intervention 1: Social Support intervention 2: NRT Sampling
Intervention descriptions: intervention 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, and a written directory of a range of social support resources delivered via mail. intervention 2: 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.

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 Study Title: Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors; MCC-17-
1495-P3K   
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
02/21/21 
NCT Number: 
NCT03316170 
IRB Number 
17-0495-P3K/45494 
Coversheet created: 
03/22/21 
 
 


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Statistical Analysis Plan 
 
Outcome Measures 
1. Accrual will be calculated as the number of participants enrolled divided by the number 
of individuals contacted about study participation. It will be reported as a percentage. 
No inferential statistical test will be conducted for this outcome. Only descriptive 
analyses apply. 
2. Retention will be calculated as the number of assessments at the end of study divided 
by the number of participants enrolled. It will be reported as a percentage. No 
inferential statistical test will be conducted for this outcome. Only descriptive analyses 
apply. 
3. Acceptability will be determined by the total score on the Treatment Acceptability and 
Preferences measure. It will be reported as a mean. An Independent samples t-test (2 
sided) will be used to examine if the treatment group reports a better outcome than the 
control group.