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Behavioural Intervention
Smoking Cessation + Pain Management Program for Cancer Survivors
Phase 4
Recruiting
Led By Kathryn I Pollak, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Report pain within the last 3 weeks of 3 or higher on a 10 point scale
Age 18 or older
Must not have
Hearing impaired
Evidence of unstable cognitive or mental health problems who cannot properly provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will test a program to help cancer survivors quit smoking and reduce pain.
Who is the study for?
This trial is for cancer survivors over 18 who have smoked at least 100 cigarettes in their lifetime, currently smoke 5+ a day, and are experiencing pain. They should be willing to quit smoking, not in another cessation study, speak English, diagnosed with cancer within the last 5 years and have a life expectancy of at least one year.
What is being tested?
Project HOPES aims to test a new program designed for cancer survivors that combines smoking cessation support with pain management. The intervention includes Varenicline—a medication used to help people stop smoking—and other strategies tailored for individuals dealing with both issues.
What are the potential side effects?
Varenicline can cause nausea, sleep disturbances (like insomnia or vivid dreams), constipation, gas and/or vomiting. Some may experience changes in taste or dry mouth. It's important to note that side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have experienced pain of 3 or more on a scale of 10 in the last 3 weeks.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have hearing difficulties.
Select...
I am able to understand and give consent for my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients who complete the study
Number of patients who report that the intervention was helpful
Secondary study objectives
Change in patient-reported pain (severity, interference)
Change in patient-reported quality of life (Coping)
Change in patient-reported quality of life (Depression/Mood/Negative Affect)
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study populationExperimental Treatment2 Interventions
All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,462 Previous Clinical Trials
2,968,900 Total Patients Enrolled
Kathryn I Pollak, PhDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
1,910 Total Patients Enrolled