NCT01630161

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
441

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 4, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2015

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2020

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

3.4 years

First QC Date

June 26, 2012

Last Update Submit

August 16, 2021

Conditions

Smoking Cessation

Keywords

relapsepreventionsmokinghabitForever Free

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Relapse at 6 Months

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

    6 Months

  • Number of Participants with Relapse at 12 Months

    Number of participants with smoking relapse at 12 months for each treatment arm.

    12 Months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants randomized to the Usual Care condition will receive standard care following recruitment.

Behavioral: Usual Care

Relapse-Prevention Intervention

ACTIVE COMPARATOR

Participants randomized to the Smoking Relapse Prevention for Cancer Patients (SRP-CaP) intervention will receive standard care plus our self-help smoking-relapse prevention materials.

Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP)

Interventions

Usual CareBEHAVIORAL

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).

Usual Care
Smoking Relapse Prevention for Cancer Patients (SRP-CaP)BEHAVIORAL

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).

Relapse-Prevention Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Smoking CessationRecurrenceSmokingHabits

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vani Simmons, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

January 4, 2012

Primary Completion

May 15, 2015

Study Completion

November 18, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

US(1)