Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 223
- 主要终点
- Biochemically validated tobacco cessation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a cancer diagnosis within the past 10 years
- •* Note: Patients with ductal carcinoma in situ (DCIS) are eligible and patients currently receiving curative treatment are eligible
- •Not currently on hospice
- •Currently smokes >= 5 cigarettes daily
- •* Note: Participants who smoke cigarettes and vape are eligible. Those who only vape are ineligible
- •Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code [RUCC] code of 4-9) and/or a Rural-Urban Commuting area code of 4-10 and/or as defined by the Office of Management and Budget as a non-rural county large area metro census tracts of at least 400 square miles in an area with population density of 35 or less per square mile with rural-urban commuting area (RUCA) codes 2-3; and outlying metro counties without a UA. The RUCC code and RUCA (4-10) codes can be checked at: https://www.ruralhealthinfo.org/am-i-rural. Those with RUCA codes of 2-3 can be checked at https://data.hrsa.gov/tools/rural-health for eligibility
- •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 for smoking purposes only), or currently participating in any cessation program at the time of enrollment
- •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 or Spanish
- •Age >= 18 years
- •Participant must be willing to provide a urine sample.
- •Patients with impaired decision-making capacity are not eligible for this study consent
排除标准
- •Psychiatric illness which would prevent the patient from giving informed consent
- •Patients with impaired decision-making capacity are not eligible for this study.
研究组 & 干预措施
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.
干预措施: Health Promotion and Education (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Smoking Cessation Intervention (Behavioral)
Group II (booklet)
Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking.
干预措施: Informational Intervention (Other)
结局指标
主要结局
Biochemically validated tobacco cessation
时间窗: 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.
次要结局
- Serially measured overall quality of life (QoL) scores obtained at baseline and at 30-days and 6-months post-quite date(Up to 6-months post-quit date)