About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
PASS2
BehavioralAn 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.
Treatment as Usual
Other interventionReferral to the local smoking cessation VA clinic.
Treatment groups
Trial outcomes
Primary outcomes
Cigarette Smoking Abstinence Rates
In keeping with the sinus node recovery time (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 outcomes
Cigarette Smoking Abstinence Rates
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
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
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.
Sponsors and contacts
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