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Smoking Relapse-Prevention Intervention for Cancer Patients

Smoking Relapse-Prevention Intervention for Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01630161
Enrollment
441
Registered
2012-06-28
Start date
2012-01-04
Completion date
2020-11-18
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

relapse, prevention, smoking, habit, Forever Free

Brief summary

The purpose of this study is to test different ways to help cancer patients maintain their smoking abstinence. Participants may receive educational materials as part of the study.

Detailed description

This study involves participation at four distinct time points over a one-year period. * Baseline assessment * 2-month follow-up telephone call * 6-month follow-up telephone call * 12-month follow-up telephone call

Interventions

BEHAVIORALUsual Care

Standard care includes routine assessment of smoking behavior and brief clinical intervention. Smoking counseling for all participants in the current study will be completed by a Certified Tobacco Treatment Specialist consisting consists of brief counseling (\<15 minutes) based on the 5 A's Clinical Practice Guidelines; Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, Arrange for follow-up (Fiore et al., 2008). Patients receive information for local and state smoking resources (e.g., Quitline), pharmacotherapy options, and if interested, assistance with obtaining a prescription for pharmacotherapy. Follow-up with patients occurs at 2-weeks, only among those who are prescribed smoking medications (i.e., Varenicline, Bupropion).

BEHAVIORALSmoking Relapse Prevention for Cancer Patients (SRP-CaP)

The proposed multimodal intervention consists of a series of easy-to-read relapse prevention booklets (Forever Free) that have shown to be efficacious with a general smoking population (Brandon et al., 2000; 2004), and digital video disk (DVD) customized to the needs of cancer patients (to be developed in Year One).

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Have smoked at least 10 cigarettes per day for at least one year prior to cancer diagnosis * Able to read and write English * Able to give informed consent * Have quit smoking after receiving their cancer diagnosis * Have not quit greater than 3 months prior

Exclusion criteria

* Individuals who have been abstinent for greater than 3 months are not included because they are less likely to relapse. A quit will be defined as self-reported no smoking for 24 hours. Individuals with metastatic disease will be excluded because participation in the study might be burdensome.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Relapse at 6 Months6 MonthsNumber of participants with smoking relapse at 6 months follow-up for each treatment arm.
Number of Participants with Relapse at 12 Months12 MonthsNumber of participants with smoking relapse at 12 months for each treatment arm.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026