Tobacco Smoking
Conditions
Keywords
tobacco smoking, chronic pain
Brief summary
The goal of this clinical trial is to develop two health-focused interventions for tobacco smokers with chronic pain. The main questions it aims to answer are: * Are the interventions feasible for delivery via telehealth? * Are the interventions acceptable to participants? This study has two phases. First, researchers will develop materials and receive feedback through three focus groups, updating the materials iteratively between each group. Next, researchers will compare the feasibility and acceptability of the two interventions. Participants in the second phase will: * Complete the a single-session telehealth intervention online * Complete surveys online before, immediately after, and at 2-weeks, 1-month, and 3-months after the intervention session.
Interventions
BEHAVIORALSmoking and Health Telehealth Intervention 1
The Smoking and Health Telehealth Intervention 1 provides educational information about how smoking is related to health and resources for smoking cessation. The intervention is delivered via live telehealth online in a single (30 minute) session.
BEHAVIORALSmoking and Health Telehealth Intervention 2
The Smoking and Health Telehealth Intervention 2 provides educational information about how smoking is related to health and resources for smoking cessation. The intervention is delivered via live telehealth online in a single (30 minute) session.
Sponsors
Binghamton University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* moderate to severe chronic pain * current daily tobacco smoking * willing and able to complete study components in English * adult (age 18 or over)
Exclusion criteria
* planning or currently attempting to quit * recent use of cessation treatments or other products to quit smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | At the participant level, time from screening through enrollment is anticipated to be up to 4 weeks. The total will be calculated at the end of the entire enrollment period of the study, which is anticipated to be approximately 1 year and 9 months. | Enroll \>80% or more of people who meet eligibility criteria. |
| Intervention Delivery Feasbility | At the participant level, intervention delivery occurs in the same session as enrollment. Overall feasibility will be assessed at the end of the entire enrollment period, which is anticipated to be 1 year and 9 months. | Delivery of the allocated intervention to at least 95% of enrolled participants. |
| Acceptability | Immediately post intervention (at the end of the intervention session). | Mean scores for each item on the Client Satisfaction Questionnaire (CSQ) of 3 or greater. Mean total CSQ score of 24 or greater. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cessation Motivation | Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session | Separate ratings of motivation, importance, readiness, and confidence in quitting smoking on a scale from 0 (none) to 10 (100%). |
| Motivation for Cessation Treatment | Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session | Self-reported (yes/no) willingness to learn about cessation treatments and accept cessation resources, and intention to use cessation treatments. |
| Cessation Treatment Engagement | 2-week, 1-month, 3-month follow-up | Self-reported (yes/no) use of cessation treatment. |
| Pain and Smoking Inventory | Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session | The Pain and Smoking Inventory measures the extent to which people believe their smoking and pain are related. |
| Pain and Smoking Questionnaire | Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session | The Pain and Smoking Questionnaire measures the extent to which participants can correctly identify known associations between smoking and multiple health conditions. |
Countries
United States
Contacts
CONTACTEmily Zale
Outcome results
None listed