Pain, Smoking, Smoking Cessation
Conditions
Brief summary
PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use nightly surveys to optimize the intervention's effectiveness 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: 1. Determine whether the existing integrated pain and smoking cessation (PASS intervention) augmented with nightly surveys (PASS2) is superior to treatment as usual (e.g., referral to standard VA smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 4 months and 10 months (primary endpoint) on cigarette abstinence rates among non-depressed Veterans with chronic pain. 2. Determine whether PASS2 is superior to E-TAU at 4 months and 10 months (primary endpoint) on pain interference. 3. Examine critical components of the intervention process to inform future program implementation.
Interventions
BEHAVIORALPASS2
An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly surveys to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.
OTHERTreatment as Usual
Referral to the local smoking cessation VA clinic.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* being an enrolled Veteran at VACHS * current tobacco use * willingness to make a quit attempt * significant chronic pain defined as \>/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days
Exclusion criteria
* active diagnosis of dementia or psychosis in medical record * severely impaired hearing or speech * lack of telephone access * enrollment in concurrent research study that might affect main outcomes of this study * terminal illness * non-English speaking * pregnancy * provider advising against exercise * planned surgeries * clinically significant depressive symptoms (\>10 PHQ-9)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Smoking Abstinence Rates | 10-month follow-up | In keeping with the SNRT recommendations for measuring abstinence, the investigators will use prolonged abstinence as our main outcome. During the 10-month follow-ups, patients will be asked about prolonged abstinence, "In the past 6 months, have you smoked a cigarette, even a puff?" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Smoking Abstinence Rates | 4-month follow up | The investigators will measure prolonged abstinence at the 4-month follow up as a secondary outcome. During the 4-month follow-ups, patients will be asked about prolonged abstinence, "In the past 3 months have you smoked a cigarette, even a puff?" |
| Point prevalent abstinence | 4-month and 10-month follow-up | Patients will be asked "Have you have smoked at least part of a cigarette, even a puff, in the past 7 days?" |
| Pain intensity and pain-related functional interference | 4-month and 10-month follow-up | Pain intensity and interference will be assessed using the 11-item Brief Pain Inventory (BPI). The BPI also assesses chronicity of pain and areas of the body with pain. The interference subscale has demonstrated adequate internal consistency and robust concurrent validity and responsivity among patients with chronic non-cancer pain. The investigators have also added the PROMIS 8-item pain interference measure and the PROMIS 3-item pain intensity measure which has comparable responsiveness to BPI and excellent internal consistency. |
Countries
United States
Contacts
CONTACTLori A Bastian, MD MPH
CONTACTMary Driscoll, PhD
PRINCIPAL_INVESTIGATORLori Anne Bastian, MD MPH
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Outcome results
None listed