Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors

The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Social Stress
• Intervention / Treatment: Behavioral: Social Support; Drug: NRT Sampling

Detailed Description

This is a pilot (Phase II) randomized clinical trial with randomization in a 1:1 ratio. The control group will receive a brief consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs. Additionally, a written directory of a range of social support resources will be delivered to them via mail. The treatment group will receive the aforesaid intervention plus brief advice to quit smoking (10-15 minutes via phone). Additionally, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) will be provided via mail. The treatment group will also receive a free, 2-week supply of nicotine patches and lozenges delivered via mail. As a pilot, this study focuses on the outcomes of feasibility (i.e., accrual and retention) and acceptability (e.g., participants' perceptions of appropriateness and effectiveness) as opposed to efficacy (though this is also important). The emphasis on smoking cessation induction (that is, the inducement or promotion of a quit attempt) is an important aspect of the study design and is appropriate for smokers across the continuum of motivation to quit.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Markey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cervical or head/neck cancer diagnosis in the past 5 years
• Resident of rural and/or Appalachian Kentucky county at cancer diagnosis
• Current smoker of ≥ 10 cigarettes per day, on average
• Age 18-75 years old
• Able to read, write, and understand English

Exclusion Criteria:

• Unreliable phone access
• Smoking cessation treatment use in past 30 days
• Non-cigarette tobacco use in the past 30 days
• Any FDA contraindication for NRT use, including: allergy to nicotine patches and/or nicotine lozenges; severe kidney or liver disease; unstable angina or serious arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months

• Cognitive or psychiatric disorder that would interfere with ability to provide informed consent or answer survey questions reliably *

  * Any of these Diagnostic and Statistical Manual-5 (DSM-5) cognitive and psychiatric disorders would make someone ineligible: bipolar; delusional; dissociative; intellectual developmental; neurocognitive; psychotic; schizophreniform, schizophrenia, and schizoaffective.

• For women: breastfeeding, pregnancy, or plan to become pregnant within 6 months
• For women of childbearing potential: unwillingness to use an effective method of birth control (e.g., abstinence, oral contraceptive) while in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Support + NRT Sampling; The treatment group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,; a written directory of a range of social support resources delivered via mail,; a brief phone consult (10-15 minutes via phone) germane to smoking cessation,; a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and; a free, 2-week supply of nicotine patches and lozenges delivered via mail.	Behavioral: Social Support; A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.; Drug: NRT Sampling; A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Active Comparator: Social Support; The control group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs,; a written directory of a range of social support resources delivered via mail,	Behavioral: Social Support; A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrual Percentage	Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100	Day 0 baseline
Retention	Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100	Through study completion, number of assessments at Day 60 follow-up
Acceptability	Total score on the Treatment Acceptability and Preferences measure (Sidani et al., 2009). This is a 4-item measure with each item scored on a scale from 0 to 4. Total scores are computed as the mean of the 4 individual items, so total scores range from 0 to 4. Higher scores indicate a better outcome, as they reflect greater acceptability of the treatment provided in this clinical trial.	Day 60 follow-up

Collaborators and Investigators

• Sponsor: Jessica Burris
• Collaborators: Kentucky Lung Cancer Research Program
• Investigators: Principal Investigator: Jessica Burris, Ph.D., University Of Kentucky

Publications and helpful links

General Publications

• Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MCC-17-0495-P3K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No