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NCT Number: NCT05008848

Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kingman Regional Medical Center, Kingman, Arizona, United States

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About this study

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of an eight-week text-based scheduled gradual reduction (SGR) intervention (a personalized eight-week reduction schedule paired with National Cancer Institute's [NCI's] Smokefree.TXT) compared to a control intervention (NCI Clearing the Air Cessation Booklet) on biochemically-validated smoking cessation six-month post-quit date in rural cancer survivors.

SECONDARY OBJECTIVE:

I. Compare the efficacy of the eight-week text-based SGR intervention and a control intervention on Linear Analog Self-Assessment (LASA)-6 overall quality of life (QOL) at 30-days post-quit date and six-months post-quit date.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in schedule gradual reduction program over 8 weeks to reduce the frequency of cigarette use. Patients also receive cessation support messages via text messages for 12 weeks.

GROUP II: Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking.

After completion of study, patients are followed up at 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment
  • Not currently on hospice
  • Currently smokes >= 5 cigarettes daily
  • Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code [RUCC] code of 4-9)
  • Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial
  • Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program
  • Patient has a cell phone or smart phone device with texting ability
  • In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
  • Age >= 18 years
  • Participant must be willing to provide a urine sample.

Exclusion criteria

  • Psychiatric illness which would prevent the patient from giving informed consent
  • Patients with impaired decision-making capacity are not eligible for this study.

Treatment and study plan

Smoking Cessation Intervention

Behavioral

Participate in schedule gradual reduction program

Health Promotion and Education

Other

Receive cessation support messages

Informational intervention

Other

Receive NCI's Clearing the Air booklet

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Biochemically validated tobacco cessation

    Time frame: Up to 6 months post-quit date

    Response will be defined as (1) urine cotinine levels < 50 ng/ml or (2) urine cotinine levels >=50 ng/ml and an urine anabasine level < 2 ng/ml if a patient self-reports vaping use or the use of nicotine replacement therapy (NRT). Patients who do not return at 6 months post-quit date for the cotinine assessment (and anabasine, if applicable) will be deemed non-responders. The analysis population is defined as all randomized and eligible patients. The primary evaluation of the primary outcome will be the covariate-adjusted intervention effect (adjusted odds ratio) obtained from a multiple logistic regression model adjusted for the three stratification factors baseline daily cigarette consumption, age, and sex as well as the potential confounding variables cancer diagnosis, cancer type, receipt of chemotherapy, receipt of radiation therapy, and active treatment.

Secondary outcomes

  1. Serially measured overall quality of life (QoL) scores obtained at baseline and at 30-days and 6-months post-quite date

    Time frame: Up to 6-months post-quit date

    At a given measurement time point, the patient-reported overall QoL score will be obtained from a linear analogue self-assessment scale (LASA), which is an 11-point scoring scale (0, 1, …, 10) where 0 indicates as bad as can be and 10 indicates as good as can be. A linear mixed model will be used to compare the average difference between the randomized arms across the two post-randomization time points after adjusting for the baseline overall QoL score, the three stratification factors baseline daily cigarette consumption, age, and sex as well as the potential confounding variables cancer diagnosis, cancer type, receipt of chemotherapy, receipt of radiation therapy, and active treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Devon Noonan, PhD, MPH, FNP-BC

CONTACT

[email protected]

919-613-9130

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2021
Registry last updated
Jul 2, 2026

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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