Pain Clinical Trial
Official title:
Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.
The proposed pilot study will develop and test feasibility, acceptability, and signal for efficacy of a smoking cessation and pain management intervention for 20 cancer survivors.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | March 9, 2025 |
Est. primary completion date | March 9, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with cancer at our targeted recruitment sites - Have a diagnosis of cancer within the past 5 years (can be currently undergoing treatment) - Have a life expectancy of at least 1 year - Report pain within the last 3 weeks of 3 or higher on a 10 point scale - Have smoked at least 100 cigarettes in their lifetime - Smoke 5 or more cigarettes per day in the prior 7 days - Be willing to try to quit smoking - Not participating in another smoking cessation trial - Age 18 or older - Speak English Exclusion Criteria: - Hearing impaired - Deemed too sick to participate - Evidence of unstable cognitive or mental health problems who cannot properly provide consent |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients who complete the study | Completing study participation is the number of those who attend all sessions and complete follow-up surveys. This will serve as our feasibility benchmark. | through study completion, an average of 1 year | |
Primary | Number of patients who report that the intervention was helpful | Patients will be asked if they found the intervention helpful on follow-up surveys. This will serve as our acceptability benchmark. | through study completion, an average of 1 year | |
Secondary | Number of Patients at 3-month Post-Intervention with Validated Cessation | Biochemically verified 7-day point prevalence smoking abstinence at 3 months with use of CO monitors. | through study completion, an average of 1 year | |
Secondary | Change in patient-reported pain (severity, interference) | Patients will report their pain on a scale from 0-10 [0 being "no pain" and 10 being "pain as bad as you can imagine"] and report how pain is affecting their lives 0-10 [0 being "does not interfere" and 10 being "completely interferes"] on administered surveys at baseline, post-intervention, and 3-month post-intervention. Study team will look to see if there is a change in patient-reported pain. | through study completion, an average of 1 year | |
Secondary | Change in patient-reported self efficacy (smoking cessation, pain management) | Patients will report their ability to stop smoking and manage their pain on administered surveys at baseline, post-intervention, and 3 month-post intervention. Self-efficacy is measured on a scale from 1 to 7 where 1 is "not confident at all" and 7 is "extremely confident". Pain management is measured on a scale of 1-10 where 1 is "very uncertain, 5 is "moderately uncertain", and 10 is "very uncertain". Study team will look to see if there is a change in patient-reported self efficacy | through study completion, an average of 1 year | |
Secondary | Change in patient-reported quality of life (Depression/Mood/Negative Affect) | Patients will respond to questions about their perceived quality of life on administered surveys at baseline, post-intervention, and 3 month post-intervention. Quality of life will be measured based on questions related to Depression/Mood/Negative Affect (Hospital Anxiety Depression Scale - HADS). The HADS is comprised of two sub scales, Depression and Anxiety. Each subscale has a score ranging from 0-21.Items are rated on a 4-point Likert-type scale ranging from 0 t o 3, generating a scale range of 0 to 42 points, with higher scores representing greater symptom severity. The anxiety subscale has 3 items that refer to panic and 4 to generalized anxiety. Add the A questions to get a score for anxiety and the D questions for depression. Scores of 0-7 indicate normal levels of anxiety and depression; 8-10 indicate borderline abnormal anxiety. Study team will look to see if there is a change in patient-reported quality of life. | through study completion, an average of 1 year | |
Secondary | Change in patient-reported quality of life (Coping) | Patients will respond to questions about their perceived quality of life on administered surveys at baseline, post-intervention, and 3 month post-intervention. Quality of life will be measured based on questions related to Coping. Patients will answer questions on scale from "never", "seldom", "occasionally", "often", or "most of the time". Subscale of the Rhode Island Stress and Coping Inventory. Study team will look to see if there is a change in patient-reported quality of life. | through study completion, an average of 1 year | |
Secondary | Change in patient-reported quality of life (Physical Well Being) | Patients will respond to questions about their perceived quality of life on administered surveys at baseline, post-intervention, and 3 month post-intervention. Quality of life will be measured based on questions related to Physical Well Being. Patients will answer questions on a 5-point scale from "0: not at all", "1: a little bit", "2: somewhat", "3: quite a bit", or "4: very much". Study team will look to see if there is a change in patient-reported quality of life. | through study completion, an average of 1 year |
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