Smoking Relapse-Prevention Intervention for Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01630161|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2012
Last Update Posted : December 4, 2017
|Condition or disease||Intervention/treatment|
|Smoking Cessation||Behavioral: Usual Care Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP)|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||441 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Smoking Relapse-Prevention Intervention for Cancer Patients|
|Actual Study Start Date :||January 4, 2012|
|Primary Completion Date :||June 8, 2016|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Usual Care
Participants randomized to the Usual Care condition will receive standard care following recruitment.
Behavioral: Usual 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).
Active Comparator: Relapse-Prevention Intervention
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)
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).
- Number of Participants with Relapse at 6 Months [ Time Frame: 6 Months ]Number of participants with smoking relapse at 6 months follow-up for each treatment arm.
- Number of Participants with Relapse at 12 Months [ Time Frame: 12 Months ]Number of participants with smoking relapse at 12 months for each treatment arm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630161
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Vani Simmons, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|