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

NCT03316170 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MCC-17-0495-P3K
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Social Stress

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Social Support + NRT Sampling

EXPERIMENTAL

The treatment group will receive: 1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, 2. a written directory of a range of social support resources delivered via mail, 3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation, 4. 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 5. a free, 2-week supply of nicotine patches and lozenges delivered via mail.

Behavioral: Social Support; Drug: NRT Sampling

Social Support

ACTIVE COMPARATOR

The control group will receive: 1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, 2. a written directory of a range of social support resources delivered via mail,

Behavioral: Social Support

Interventions

Social Support BEHAVIORAL

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.

Social Support; Social Support + NRT Sampling

NRT Sampling DRUG

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.

Social Support + NRT Sampling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessica Burris: lead
• Kentucky Lung Cancer Research Program: collaborator

Study Sites (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• 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.

  PMID: 19434647 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Jessica Burris
• Organization: University of Kentucky

jessica.burris@uky.edu

+1 859-257-9612

Study Officials

• Jessica Burris, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 20, 2017
• Study Start: November 6, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)