Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients

NCT01434342 | Completed Early Phase 1 Results DMC FDA Drug

• 3 other identifiers: IRB000019384U10CA081851REBACCCWFU 99211
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Continued smoking after a cancer diagnosis has important health consequences beyond the risks associated with smoking in the general population. Smoking reduces the efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the negative consequences, it is estimated that between 15-75% of patients with cancer continue to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head \& neck, and cervical cancer patients were chosen because there is evidence of potential clinical benefit associated with quitting smoking in all of these populations and they represent a mix of both smoking and non-smoking related cancers.

Conditions

Lung Cancer; Tobacco Use Disorder; Breast Cancer; Colorectal Cancer; Prostate Cancer

Keywords

stage IA non-small cell lung cancer; stage IB non-small cell lung cancer; stage IIA non-small cell lung cancer; stage IIB non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; limited stage small cell lung cancer; tobacco use disorder; Breast Cancer; Cervical Cancer; head & neck cancer; Prostate Cancer; All histologies

Outcome Measures

Primary Outcomes (2)

• Feasibility of a Smoking Cessation Intervention Among Cancer Patients

  The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.

  24 Weeks

• Adherence

  Adherence is measured by the percentage of randomized participants who have a Quitline call. Note that this outcome is only defined for the Intervention arm

  24 weeks

Study Arms (2)

Arm I - Quitline

EXPERIMENTAL

Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.

Drug: Nicotine Replacement Patch

Arm II - Usual Care

NO INTERVENTION

Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.

Interventions

Nicotine Replacement Patch DRUG

Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 weeks after the date of the in-person intervention (for Quitline Intervention group) or the provision of the physician letter (for the Usual Care Plus group).

Also known as: Nicotine patch, Habitrol patch

Arm I - Quitline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AJCC Stages 0, I, II, \& III lung, breast, prostate, colorectal, bladder, head \& neck, and cervical cancers (all histologies).
• Reports smoking any amount in the last 7 days.
• Scheduled to receive or currently receiving surgery, radiation or chemotherapy OR have received one or more of the following in the last 6 months surgery, last radiation treatment or last chemotherapy treatment.
• years of age or older
• KPS of 70-100
• Ability to understand and the willingness to sign a written informed consent document.
• Willing to consider quitting smoking

You may not qualify if:

• Unstable cardiac disease - defined as congestive heart failure, unstable angina, serious arrhythmias, or Myocardial Infarction in the past month.
• Current use or planned use of varenicline (Chantix), Zyban, Buproprion or any other nicotinic receptor agonist (Patients that discontinue use of these type drugs within 7 days are eligible.)
• Current probable alcohol abuse as defined by more than 5 drinks per day for men and 4 drinks per day for women and a Alcohol Use Disorders Identification Test (AUDIT) score \> 8.
• If patient answers "no" to 5 drinks per day for men and 4 drinks per day for women the patient is eligible. AUDIT assessment does not need to be administered.
• If patient answers "yes " to 5 drinks per day for men and 4 drinks per day for women the AUDIT assessment must be administered. If AUDIT score is \> 8 patient is not eligible.
• Use of illegal drugs or use of prescription medications for non-medical reasons in the past month.
• Current use of chewing, dipping and pipe tobacco, or cigars.
• Patient does not have regular access to a telephone to receive Quitline calls lasting 15-30 minutes.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to nicotine replacement therapy.
• Active Peptic Ulcer Disease
• Uncontrolled intercurrent illness including, but not limited to, ongoing, psychiatric illness/social situations that would limit compliance with study requirements.
• Due to unknown risks and potential harm to the unborn fetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. We encourage you to discuss this issue further with your doctors if you have any questions.
• If you are pregnant, should become pregnant or suspect you are pregnant prior to or while participating in this study, you should inform your study physician immediately. Nicotine replacement therapy has the potential for teratogenic or abortifacient effects and is classified as a FDA Pregnancy category D drug. The U.S. Clinical Practice Guideline states that pregnant smokers should be encouraged to quit without medication based on insufficient evidence of effectiveness and hypothetical concerns with safety. Pregnant women enrolled in the study and randomized to the Quitline group intervention should participate in the Quitline intervention but not receive the nicotine replacement therapy.
• Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nicotine replacement therapy, breastfeeding women are excluded from the study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

W F Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Links

• Quitline Based Smoking Cessation

MeSH Terms

Conditions

Lung Neoplasms; Tobacco Use Disorder; Breast Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Head and Neck Neoplasms

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Doug Case
• Organization: Wake Forest NCORP Research Base

dcase@wakehealth.edu

(336) 716-1048

Study Officials

• Kathryn Weaver, PhD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 14, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: January 1, 2015
• Last Updated: September 28, 2021
• Results First Posted: June 6, 2017

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)