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Behavioural Intervention

Smoking Cessation + Pain Management Program for Cancer Survivors

Phase 4

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients who complete the study

Number of patients who report that the intervention was helpful

Secondary outcome measures

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 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,049 Total Patients Enrolled

Kathryn I Pollak, PhDPrincipal InvestigatorDuke University

3 Previous Clinical Trials

1,910 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the target group of this research been approved by the FDA?

"This study population was judged 3 out of 3 in terms of safety, with the consensus being that this phase 4 trial denotes a treatment already approved by regulatory bodies."

Answered by AI

Could you tell me if potential participants are presently being accepted for this trial?

"Per the data on clinicaltrials.gov, this trial is not presently seeking participants as it was posted initially on September 15th 2023 and had its last update on September 1st 2023. However, there are currently 510 other trials that are actively recruiting patients across a variety of medical conditions."

Answered by AI

What objectives are investigators seeking to accomplish through this clinical trial?

"This medical trial has two major objectives; the first is to measure how many patients find their treatment helpful and the second includes a thorough evaluation of patient-reported pain, self efficacy (particularly for smoking cessation and pain management), and quality of life (measured using the Hospital Anxiety Depression Scale - HADS). Pain severity will be assessed on a 0-10 scale, with interference rated on another 0-10 scale. Self efficacy is scored from 1 to 7 while Quality of Life scores range between 0-42 points. The study team aims to observe any changes in these factors over an average period of one year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.

2024. "Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029907.

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