Clinical trial NCT06029907: Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.
Official title: Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Smoking Cessation
Pain
Keywords: Smoking cessation
Pain management
Cancer survivors
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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. There are two specific aims:

Aim 1: To test the feasibility and acceptability of a behavioral smoking cessation and pain management intervention combined with varenicline.

Aim 2: To examine the smoking cessation rate and changes in pain (i.e., severity, interference), self-efficacy (i.e., smoking cessation, pain management), and quality of life from baseline to post-intervention and 3-months post-baseline.

The proposed intervention could have a great impact on the health and quality of life of cancer survivors. Teaching pain management techniques coupled with smoking cessation techniques addresses two critical issues for survivors.

The study team submitted an R01 based on a prior pilot study. Reviewers were enthusiastic about the significance and innovation of addressing smoking and pain simultaneously. They were, however, not convinced by the potential efficacy of our pilot data. They suggested the study team test the same intervention with varenicline as it can both help promote smoking cessation and provide some analgesia for pain. To address reviewer concerns to lead to R01 funding, the study team proposes to build on our combined behavioral smoking cessation and behavioral pain intervention by adding varenicline.

BACKGROUND AND SIGNIFICANCE:

The US currently has an estimated 15.5 million cancer survivors. Approximately 10-30% of all cancer survivors are current smokers at diagnosis. Well more than half (70%) of survivors who are current smokers at diagnosis will either resume smoking after an initial quit attempt or continue smoking following their diagnosis. Those who live in rural areas have an even higher rate of smoking. As many as 70% also suffer from pain as well as other physical and/or psychosocial problems. Although some survivors hold beliefs that smoking reduces pain and alleviates distress, in fact, persistent smoking following cancer diagnosis is associated with worse pain, poor quality of life, increased risk for disease recurrence, and worsening of many comorbid medical conditions. Of importance, quitting smoking significantly improves survivors' response to cancer treatment, reduces cancer recurrence, mitigates risk of new cancers and cardiovascular disease and improves quality of life. Thus, helping survivors quit smoking and learn how to manage their pain is a top priority for oncology providers.

To date, integration of best practices for promoting smoking cessation and pain management among cancer survivors has received little attention, despite smokers who experience pain reporting lower self-efficacy for quitting and greater expectancies of severe withdrawal and poor cessation outcomes. Building upon our longstanding expertise in smoking cessation and pain management interventions, the study team proposes to build on our pilot work by including a pharmacologic agent that can enhance both cessation and pain management. Among pharmacologic treatments, varenicline (i.e., Chantix) has the strongest evidence for helping people quit smoking. Varenicline also acts on receptors to potentially block pain. The study team submitted an R01, and reviewers wanted stronger pilot data that convinced them more that combining a smoking cessation and pain management intervention would help survivors quit smoking. Thus, in addition to published pilot data the study team have with cancer survivors recruited from the Duke Cancer Network (DCN), the study team proposes to recruit survivors who smoke to test whether the study team can increase our cessation rate by adding varenicline to our behavioral smoking cessation pain management program. In our prior pilot, the study team found promising evidence for the feasibility, acceptability, and signal for efficacy of a combined behavioral smoking cessation with nicotine replacement patches and behavioral pain management intervention. Survivors who received the intervention rated it as useful for smoking cessation and pain management. Survivors who received the intervention were more likely to quit smoking than those in the control arm, but only a few survivors quit. Survivors in the intervention compared to the control arm reported improvements in their pain as well as depression and physical well-being, but again these changes were small. Thus, in this proposed pilot, the study team will examine whether adding varenicline to our behavioral program helps more survivors quit smoking and report better pain management. Our primary outcomes will be feasibility, acceptability, and evidence for potential of future efficacy testing a new combination of behavioral smoking cessation and behavioral pain management + varenicline. Our secondary outcome will be biochemically verified 7-day point prevalence smoking abstinence at 3 months. The study team will also examine pain, self-efficacy (smoking, pain management), and quality of life.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who complete the study
timeFrame: through study completion, an average of 1 year
measure: Number of patients who report that the intervention was helpful
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of Patients at 3-month Post-Intervention with Validated Cessation
timeFrame: through study completion, an average of 1 year
measure: Change in patient-reported pain (severity, interference)
timeFrame: through study completion, an average of 1 year
measure: Change in patient-reported self efficacy (smoking cessation, pain management)
timeFrame: through study completion, an average of 1 year
measure: Change in patient-reported quality of life (Depression/Mood/Negative Affect)
timeFrame: through study completion, an average of 1 year
measure: Change in patient-reported quality of life (Coping)
timeFrame: through study completion, an average of 1 year
measure: Change in patient-reported quality of life (Physical Well Being)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Kathryn I Pollak, PhD
role: PRINCIPAL_INVESTIGATOR
References: