NCT05008848 Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
| NCT ID | NCT05008848 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alliance for Clinical Trials in Oncology |
| Condition | Cigarette Smoking-Related Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2022-04-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Devon Noonan, PhD, MPH, FNP-BC
STUDY CHAIR
Duke School of Nursing
Frequently Asked Questions
Who can join the NCT05008848 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cigarette Smoking-Related Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05008848 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT05008848 currently recruiting?
Yes, NCT05008848 is actively recruiting participants. Contact the research team at devon.noonan@duke.edu for enrollment information.
Where is the NCT05008848 trial being conducted?
This trial is being conducted at Kingman, United States, Fort Smith, United States, St. Helena, United States, Greeley, United States and 11 additional locations.
Who is sponsoring the NCT05008848 clinical trial?
NCT05008848 is sponsored by Alliance for Clinical Trials in Oncology. The principal investigator is Devon Noonan, PhD, MPH, FNP-BC at Duke School of Nursing. The trial plans to enroll 600 participants.