Pain, Smoking, Smoking Cessation
Conditions
Keywords
Smoking, Cigarette Smoking, Veterans, Tobacco Use, Pain
Brief summary
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
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.
Interventions
BEHAVIORALSmoking Cessation plus CBI
proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
BEHAVIORALSmoking Cessation Standard
standard telephone-based smoking cessation intervention
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence) | 12 month post intervention | 30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days? |
| Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence) | 6-month | In the past 6 months, have he/she smoked any in each of 2 consecutive weeks? |
| Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence) | 12-month post intervention | In the past 6 months, have he/she smoked any in each of 2 consecutive weeks? |
| Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence) | 6-month post intervention | 30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months | Baseline to 6-month post intervention | 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. |
| Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months | Baseline to 6-month post intervention | 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. |
| Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months | Baseline to 12-month post-intervention | 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. |
| Change in Pain Interference, Difference Between Baseline and Interference | Baseline to 12-month post intervention | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain | 189 |
| Smoking Cessation Standard (SMK-STD) A contact-equivalent control that provides standard smoking cessation telephone counseling
Smoking Cessation Standard: standard telephone-based smoking cessation intervention | 182 |
| Total | 371 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 44 | 56 |
Baseline characteristics
| Characteristic | Smoking Cessation Plus CBI (SMK-CBI) | Smoking Cessation Standard (SMK-STD) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 56 Participants | 52 Participants | 108 Participants |
| Age, Categorical Between 18 and 65 years | 133 Participants | 130 Participants | 263 Participants |
| Age, Continuous | 60 Years | 60 Years | 60 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 16 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 179 Participants | 165 Participants | 344 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 47 Participants | 97 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 14 Participants | 21 Participants |
| Race (NIH/OMB) White | 123 Participants | 112 Participants | 235 Participants |
| Region of Enrollment United States | 189 Participants | 182 Participants | 371 Participants |
| Sex: Female, Male Female | 18 Participants | 26 Participants | 44 Participants |
| Sex: Female, Male Male | 171 Participants | 156 Participants | 327 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 189 | 0 / 182 |
| other Total, other adverse events | 0 / 189 | 0 / 182 |
| serious Total, serious adverse events | 0 / 189 | 0 / 182 |
Outcome results
Primary
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?
Time frame: 12-month post intervention
Population: Veteran population who smoked at least 4 cigarettes a week and pain intensity scores \>4 for at least 3 months. There were 271/371 12m responders, non-responders were assumed to continue smoking
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Plus CBI (SMK-CBI) | Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence) | 40 Participants |
| Smoking Cessation Standard (SMK-STD) | Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence) | 38 Participants |
Primary
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?
Time frame: 6-month
Population: Veteran population who smoked at least 4 cigarettes a week and pain intensity scores \>4 for at least 3 months. There were 227/371 6m responders, non-responders were assumed to continue smoking
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Plus CBI (SMK-CBI) | Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence) | 43 Participants |
| Smoking Cessation Standard (SMK-STD) | Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence) | 41 Participants |
Primary
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?
Time frame: 12 month post intervention
Population: Veteran population who smoked at least 4 cigarettes a week and pain intensity scores \>4 for at least 3 months. There were 271/371 12m responders, non-responders were assumed to continue smoking
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Plus CBI (SMK-CBI) | Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence) | 25 Participants |
| Smoking Cessation Standard (SMK-STD) | Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence) | 18 Participants |
Primary
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?
Time frame: 6-month post intervention
Population: There were 227/371 6m responders, no responders were assumed to continue smoking
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Plus CBI (SMK-CBI) | Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence) | 23 Participants |
| Smoking Cessation Standard (SMK-STD) | Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence) | 11 Participants |
Secondary
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.
Time frame: Baseline to 6-month post intervention
Population: 14 of the 227 6m responders were missing data at least 1Q and were excluded from dataset. All 4Q are needed for BPI pain intensity to be scored.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Plus CBI (SMK-CBI) | Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months | -0.7 score on a scale | Standard Deviation 1.7 |
| Smoking Cessation Standard (SMK-STD) | Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months | -0.5 score on a scale | Standard Deviation 1.8 |
Secondary
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.
Time frame: Baseline to 12-month post-intervention
Population: 24 of the 271 12m responders were missing data at least 1Q and were excluded from dataset. All 4Q are needed for BPI pain intensity to be scored.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Plus CBI (SMK-CBI) | Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months | -.044 score on a scale | Standard Deviation 1.6 |
| Smoking Cessation Standard (SMK-STD) | Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months | -0.35 score on a scale | Standard Deviation 1.7 |
Secondary
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.
Time frame: Baseline to 6-month post intervention
Population: 20 of the 227 6m responders were missing data at least 4/7Q and were excluded from dataset. At least 50% of questions need to be answered for pain interference to be calculated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Plus CBI (SMK-CBI) | Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months | -0.72 score on a scale | Standard Deviation 2.4 |
| Smoking Cessation Standard (SMK-STD) | Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months | -0.36 score on a scale | Standard Deviation 2.2 |
Secondary
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
Time frame: Baseline to 12-month post intervention
Population: 29 of the 271 12m responders were missing data at least 4/7Q and were excluded from dataset. At least 50% of questions need to be answered for pain interference to be calculated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Plus CBI (SMK-CBI) | Change in Pain Interference, Difference Between Baseline and Interference | -.56 score on a scale | Standard Deviation 2.3 |
| Smoking Cessation Standard (SMK-STD) | Change in Pain Interference, Difference Between Baseline and Interference | -.46 score on a scale | Standard Deviation 2.1 |