Efficacy of Tobacco Quitline for Cancer Survivors
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/1/2014 |
| Start Date: | October 2008 |
| End Date: | November 2013 |
| Contact: | Robert C Klesges, PhD |
| Email: | info@stjude.org |
| Phone: | 1-866-278-5833 |
The proposed study is a two-armed randomized controlled clinical trial examining the
long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in
a high risk medical population; namely, cancer survivors: Proactive telephone recruitment
through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion
of Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as
the primary methods of recruitment.
The specific aims of the study :
(1) To recruit nationally a cohort of approximately 1242 smokers who are cancer
survivors(621 childhood cancer survivors and 621 adult cancer survivors); 2) To determine
the long-term (one year) efficacy of the intervention condition for participants randomly
assigned to the Counselor-initiated versus a Self-paced QL; and (3) to find out whether
treatment outcomes vary as a function of survivors' age of cancer diagnosis (survivors who
diagnosed while adults vs. childhood cancer survivors who diagnosed before the age of 21).
long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in
a high risk medical population; namely, cancer survivors: Proactive telephone recruitment
through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion
of Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as
the primary methods of recruitment.
The specific aims of the study :
(1) To recruit nationally a cohort of approximately 1242 smokers who are cancer
survivors(621 childhood cancer survivors and 621 adult cancer survivors); 2) To determine
the long-term (one year) efficacy of the intervention condition for participants randomly
assigned to the Counselor-initiated versus a Self-paced QL; and (3) to find out whether
treatment outcomes vary as a function of survivors' age of cancer diagnosis (survivors who
diagnosed while adults vs. childhood cancer survivors who diagnosed before the age of 21).
In this study participants (n=1242) will be randomly assigned to a Counselor-Initiated
Tobacco Quit Line (QL;) in which the counselor contacts the client with the standardized
intervention protocol, or a Self-Paced Tobacco QL (which leaves the calling up to
participants).The proposed active intervention will be a the Counselor-Initiated QL which
includes 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions
of a behavioral intervention. The comparison condition will be the Self-Paced QL with
provision of 2 weeks of NRT and encouraged obtainment of additional NRT. If participants in
the Self-Paced condition make all six calls, they will receive the same behavioral
intervention as in the Counselor-Initiated condition.
Tobacco Quit Line (QL;) in which the counselor contacts the client with the standardized
intervention protocol, or a Self-Paced Tobacco QL (which leaves the calling up to
participants).The proposed active intervention will be a the Counselor-Initiated QL which
includes 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions
of a behavioral intervention. The comparison condition will be the Self-Paced QL with
provision of 2 weeks of NRT and encouraged obtainment of additional NRT. If participants in
the Self-Paced condition make all six calls, they will receive the same behavioral
intervention as in the Counselor-Initiated condition.
Inclusion Criteria:
- Participants smokes cigarettes
- Participants is a cancer survivor
- Participant must be at least 18 years of age.
- Childhood cancer survivors must be at least one year out active cancer treatment.
- Participant understands consent procedures.
- Participant speaks English.
- Participant must have access to a telephone for participation
Exclusion Criteria:
- Inability to understand consent procedures
- Participants with a known contraindication or sensitivity to nicotine replacement
therapy may participate in this study; however they will not receive nicotine
replacement therapy (NRT) as part of their smoking cessation program.
- Since our participants are childhood cancer survivors and they can be medically
fragile and we are interested in providing all eligible participants with NRT to
enhance their ability to quit smoking, we added a cautionary conditions list to the
recruitment screening form. Those with severe arrhythmias, myocardial infarction,
unstable angina, cerebrovascular incident, blood vessel disease, phaeochromocytoma,
diabetes, hyperthyroidism, abnormal kidney or liver function, or history of gastritis
or peptic ulcers, or who smoke less than 5 cigarettes per day will not receive NRT.
- Patients with questionable NRT eligibility will be discussed/reviewed on a case by
case basis with the Staff Family Physician
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