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Smoking Relapse-Prevention Intervention for Cancer Patients

Phase 2
18 Years
Open (Enrolling)
Smoking Cessation

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Trial Information

Smoking Relapse-Prevention Intervention for Cancer Patients

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

Inclusion Criteria:

- Have smoked at least 10 cigarettes per day for at least one year prior to cancer

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of Participants with Relapse at 6 Months

Outcome Description:

Number of participants with smoking relapse at 6 months follow-up for each treatment arm.

Outcome Time Frame:

6 Months

Safety Issue:


Principal Investigator

Vani Simmons, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

February 2016

Related Keywords:

  • Smoking Cessation
  • relapse
  • prevention
  • smoking
  • habit
  • Forever Free
  • Smoking



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612