NCT06029907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2025

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

August 23, 2023

Last Update Submit

September 3, 2025

Conditions

Smoking CessationPain

Keywords

Smoking cessationPain managementCancer survivors

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Number of Patients at 3-month Post-Intervention with Validated Cessation

    through study completion, an average of 1 year

  • Change in patient-reported pain (severity, interference)

    through study completion, an average of 1 year

  • Change in patient-reported self efficacy (smoking cessation, pain management)

    through study completion, an average of 1 year

  • Change in patient-reported quality of life (Depression/Mood/Negative Affect)

    through study completion, an average of 1 year

  • Change in patient-reported quality of life (Coping)

    through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (1)

Study population

OTHER

All patients will receive a smoking cessation and pain management intervention combined with clinician-prescribed varenicline.

Other: Smoking cessation and pain management interventionDrug: Varenicline

Interventions

Smoking cessation and pain management interventionOTHER

Patients will receive a behavioral smoking cessation and pain management intervention

Study population
VareniclineDRUG

Patients will receive varenicline prescribed by their oncologist

Also known as: Chantix, Chantix Starting Month Box, Tyrvaya
Study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hearing impaired
  • Deemed too sick to participate
  • Evidence of unstable cognitive or mental health problems who cannot properly provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Smoking CessationPainAgnosia

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Kathryn I Pollak, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 8, 2023

Study Start

July 15, 2024

Primary Completion

August 29, 2025

Study Completion

August 29, 2025

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)