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Trial record 1 of 1 for:    a211901
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Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05008848
Recruitment Status : Recruiting
First Posted : August 17, 2021
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking-Related Carcinoma Behavioral: Smoking Cessation Intervention Other: Health Promotion and Education Other: Informational Intervention Other: Questionnaire Administration Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (SGR program, text messages)
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.
Behavioral: Smoking Cessation Intervention
Participate in schedule gradual reduction program

Other: Health Promotion and Education
Receive cessation support messages

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group II (booklet)
Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking.
Other: Informational Intervention
Receive NCI's Clearing the Air booklet




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05008848


Contacts
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Contact: Devon Noonan, PhD, MPH, FNP-BC 919-613-9130 devon.noonan@duke.edu

Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Devon Noonan, PhD, MPH, FNP-BC Duke School of Nursing
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT05008848    
Other Study ID Numbers: A211901
NCI-2021-03543 ( Registry Identifier: NCI Clinical Trial Reporting Program )
UG1CA189823 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2021    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No