Pain and Smoking Study

Study Overview
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Brief Summary
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This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain

Detailed Description
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Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (>50%) with chronic pain continue to smoke. This study aims to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain. Proposed is a randomized comparative effectiveness trial with a two-group design in which 370 Veteran smokers with chronic pain will be randomized to either: 1) smoking cessation plus CBI (SMK-CBI), an intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking cessation telephone counseling control (SMK Control), a contact-equivalent control that provides standard smoking cessation telephone counseling and a tele-medicine clinic for accessing NRT.

Official Title
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Pain-related Anxiety Intervention for Smokers With Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans

Conditions
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Smoking, Pain, Smoking Cessation

Intervention / Treatment
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* Behavioral: Smoking Cessation plus CBI
* Behavioral: Smoking Cessation Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans enrolled at VA Connecticut or VA Central Western Massachusetts Current Cigarette Smokers Willing to make quit attempt in next 30 days Pain intensity 4 or greater on scale 0-10, self-reported Exclusion Criteria: Non-English speaking No access to telephone/Lack of Telephone Access Severely impaired hearing Active diagnosis Terminal Illness Refusal to provide informed consent Enrolled in concurrent smoking cessation programs/research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking Cessation plus CBI (SMK-CBI)<br>An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain | Behavioral: Smoking Cessation plus CBI<br>* proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain<br>* Other names: SMK-CBI;|
| Active Comparator: Smoking Cessation Standard (SMK-STD)<br>A contact-equivalent control that provides standard smoking cessation telephone counseling | Behavioral: Smoking Cessation Standard<br>* standard telephone-based smoking cessation intervention<br>* Other names: SMK-STD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence) | In the past 6 months, have he/she smoked any in each of 2 consecutive weeks? | 6-month | 
| Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence) | In the past 6 months, have he/she smoked any in each of 2 consecutive weeks? | 12-month post intervention | 
| Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence) | 30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days? | 6-month post intervention | 
| Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence) | 30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days? | 12 month post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months | BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased. | Baseline to 6-month post intervention | 
| Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months | Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased. | Baseline to 6-month post intervention | 
| Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months | BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased. | Baseline to 12-month post-intervention | 
| Change in Pain Interference, Difference Between Baseline and Interference | Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased | Baseline to 12-month post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Cigarette Smoking, Veterans, Tobacco Use, Pain