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Completed

NCT Number: NCT03316170

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Accrual Percentage

    Time frame: Day 0 baseline

    Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100

  2. Retention

    Time frame: Through study completion, number of assessments at Day 60 follow-up

    Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100

  3. Acceptability

    Time frame: Day 60 follow-up

    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.

Sponsors and collaborators

Lead sponsor

Jessica Burris

Other

Collaborators

  • Kentucky Lung Cancer Research Program

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2017
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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