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Exploring Models to Eliminate Cancer Disparities Among African American and Latino Populations: Research and Community Solutions Supplement to Cancer
Reaching and Treating Spanish-Speaking Smokers Through the National Cancer Institute’s Cancer Information Service A Randomized Controlled Trial
David W. Wetter, PhD1 Carlos Mazas, PhD1 Patricia Daza, PhD2 Lynne Nguyen, MPH3 Rachel T. Fouladi, PhD4 Yisheng Li, PhD5 Ludmila Cofta-Woerpel,
Although the prevalence of smoking is lower among Hispanics than among the general population, smoking still levies a heavy public health burden on this underserved group. The current study, Adio´s al Fumar (Goodbye to Smoking), was designed to increase the reach of the Spanish-language smoking cessation counseling service provided by the National Cancer Institute’s Cancer InformaPhD
3,6
1
Department of Health Disparities Research, The University of Texas M. D. Anderson Cancer Center, Houston, Texas. 2
Department of Psychiatry, Menninger Clinic, Baylor College of Medicine, Houston, Texas.
tion Service (CIS) and to evaluate the efficacy of a culturally sensitive, proactive, behavioral treatment program among Spanish-speaking smokers. Adio´s was a 2-group randomized clinical trial evaluating a telephone-based smoking cessation intervention. Spanish-speaking smokers (N ¼ 297) were randomized to receive either standard counseling or enhanced counseling (EC). Paid media was used to increase the reach of the Spanish-language smoking cessation services offered by the CIS. The Adio´s sample was of very low socioeconomic status (SES), and more than 90% were immigrants. Calls to the CIS requesting smoking cessation help in
3
Cancer Information Service, The National Cancer Institute, Houston, Texas.
Spanish increased from 0.39 calls to 17.8 calls per month. The unadjusted effect
4
after controlling for demographic and tobacco-related variables (OR ¼ 3.8, P ¼ .048). Adio´s al Fumar demonstrated that it is possible to reach, retain, and
5 Department of Biostatistics and Applied Mathematics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.
deliver an adequate dose of treatment to a very low SES population that has tra-
Department of Psychology, Simon Fraser University, Burnaby, British Columbia, Canada.
6
Department of Behavioral Science, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.
of EC only approached significance (OR ¼ 2.4, P ¼ .077), but became significant
ditionally been viewed as difficult to reach and hard to follow. Moreover, the findings suggest that a proactive, telephone-counseling program, based on the Treating Tobacco Use and Dependence Clinical Practice Guideline and adapted to be culturally appropriate for Hispanics, is effective. Cancer 2007;109(2 Suppl): 406–13. 2006 American Cancer Society.
KEYWORDS: smoking cessation, cancer prevention, Hispanics, health promotion, tobacco control. Presented at Exploring Models to Eliminate Cancer Disparities Among African American and Latino Populations: Research and Community Solutions, Atlanta, GA, April 21–22, 2005.
H
ispanics are the largest minority group in the United States (U.S.) and represent 12.5% of the U.S. population.1 Although the prevalence of smoking is lower among Hispanics than among the general population (16.4% vs. 22.7%),2 smoking still levies a terrible
Supported by the Minority Health Research and Education Program of the Texas Higher Education Coordinating Board and by grants R01 CA94826, R01 CA89350, and R25 CA57730 from the National Cancer Institute.
Service and the Adio´s al Fumar research team for their tireless efforts in conducting this study.
of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Unit 125, Houston TX 77030, USA; Fax: 713-563-3445; E-mail:
[email protected]
We sincerely thank the staffs of both the National Cancer Institute’s South Central Cancer Information
Address for reprints: David W. Wetter, PhD, Department of Health Disparities Research, The University
Received June 30, 2006; accepted September 6, 2006.
ª 2006 American Cancer Society
DOI 10.1002/cncr.22360 Published online 5 December 2006 in Wiley InterScience (www.interscience.wiley.com).
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public health burden on this group. Five of the 10 leading causes of death among Hispanics are related to smoking (i.e., heart disease, cancer, stroke, birth defects, and chronic respiratory diseases),3 and lung cancer is the leading cause of cancer death among Hispanics.4 Because of the tremendous public health burden attributable to smoking among minority populations, as well as the dearth of smoking cessation interventions designed to help minorities and underserved populations, the development and evaluation of such interventions has been identified as a national health priority.4,5 The current study, Adio´s al Fumar, was designed to evaluate strategies for increasing the reach of smoking cessation interventions among Spanish-speaking smokers and to evaluate the efficacy of a culturally sensitive, proactive, behavioral treatment program.
In addition, there has been little research addressing the efficacy of behavioral treatments for smoking cessation among Hispanics.4 For example, a recent review of the smoking cessation behavioral treatment literature among minorities found only 10 studies meeting inclusion criteria that focused on Hispanics, with only 5 of those studies reflecting true experimental designs.9 Furthermore, only 1 of those experimental trials found a significant treatment effect, and that was among a special population of Hispanics (military personnel).10 The authors concluded that although there was some evidence for effective treatments among African Americans, the same did not hold true for other minority groups, including Hispanics.9 Therefore, there is a tremendous need for research evaluating the efficacy of behavioral treatments among Hispanics.
RE-AIM In designing the intervention, Adio´s utilized the ‘‘REAIM’’ conceptual framework developed by Glasgow and colleagues6 for evaluating the effectiveness of public health interventions. RE-AIM represents reach, efficacy, adoption, implementation, and maintenance. Reach refers to the proportion of the target population who receive the intervention, whereas efficacy reflects the proportion of the population receiving the intervention who successfully change their behavior. Adoption refers to the proportion of providers/settings who agree to use the intervention. Implementation is the extent to which providers/settings deliver the intervention as intended, and maintenance reflects the extent to which the delivery of the intervention becomes institutionalized and maintained over time. There are many barriers to reaching Hispanic smokers, including language limitations, low availability and accessibility of appropriate providers and services, cost, and inadequate insurance coverage. For example, 41% of the U.S. Hispanic population speak only Spanish or have limited English proficiency,1 suggesting that interventions need to be offered in Spanish. Moreover, even after controlling for socioeconomic and health status, Hispanics are less likely than non-Hispanics to have health insurance or a personal health care provider, and, not surprisingly, are also less likely than non-Hispanics to have received preventive care, including the receipt of cessation advice from a physician during a quit attempt.3,7,8 Thus, access to smoking cessation treatments among Hispanics is limited when compared with non-Hispanics, and particularly so for individuals with no or limited English proficiency.
Telephone Counseling as a Treatment Delivery Modality Based on the RE-AIM criteria, telephone counseling may be a particularly appropriate treatment delivery modality for several reasons. Most important, telephone counseling has demonstrated efficacy.5,11,12 For example, in one of the most rigorous evaluations and syntheses of the smoking cessation literature ever conducted, a meta-analysis in the Treating Tobacco Use and Dependence Clinical Practice Guideline (Guideline) indicated that proactive telephone counseling significantly increased long-term abstinence rates.5 Second, telephone counseling has a broad reach into the target population, as 85% of Hispanic households have telephone service.13 In fact, there are few, if any, intervention delivery modalities that have broader reach, and perhaps none when delivering person-to-person interventions. Third, telephone counseling can overcome many of the barriers to obtaining adequate health care often faced by Hispanics. Telephone counseling is convenient; inexpensive relative to in-person interventions; reduces the required time commitment; overcomes geographic isolation; requires no travel, childcare, or parking; and is offered in Spanish fairly often. Fourth, person-to-person treatment is more effective than self-help materials, and there is a strong dose–response relationship between session length, treatment duration, and outcome such that more person-to-person treatment is generally beneficial.5 The Guideline recommends 4 or more counseling sessions because of the corresponding 2- to 3-fold increase in cessation rates over a single session.5 Because telephone counseling eliminates many of the
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barriers to in-person treatment, it may be possible to deliver telephone-based interventions that are of higher intensity with respect to the number and duration of sessions than is feasible when treatment is delivered in a health care or community setting. Providing smokers with more intensive treatments that are readily available could significantly boost the proportion of smokers who are able to successfully quit. Fifth, cost-effectiveness is a critical factor influencing allocation of public health resources, and telephone counseling has the potential to be very cost-effective, particularly when compared with other person-to-person modalities. Finally, telephone counseling is already used in numerous population-based settings for tobacco control (e.g., state quitlines, health care organizations, etc.). In fact, residents of all 50 states, the District of Columbia, and Puerto Rico all have access to free tobacco cessation quitline services. Therefore, because new telephone treatment programs have excellent potential to be adopted, implemented, and maintained given currently available services and resources, Adio´s al Fumar utilized telephone counseling as the treatment delivery modality.
Partnership With the National Cancer Institute’s Cancer Information Service The National Cancer Institute’s (NCI) Cancer Information Service (CIS) provides quitline services to all states where local or state-wide services are not available. At the time of the study, the South Central CIS at the University of Texas M. D. Anderson Cancer Center was one of only two CIS call centers in the United States that provided smoking cessation counseling in Spanish. The smoking cessation counseling provided by the CIS at that time consisted of a single counseling call, included a toll-free number, and was completely free of charge. Callers could choose to remain anonymous. Despite the advantages and demonstrated efficacy of a telephone counseling program such as that provided by the CIS, this resource was grossly underutilized by Spanish-speaking individuals. In the 18 months prior to the start of Adio´s, only 7 people in Texas called the South Central CIS Spanish-language line requesting help for smoking cessation. Therefore, the aims of Adio´s al Fumar were to evaluate 1) paid media approaches for increasing the utilization of the CIS Spanish-language smoking cessation counseling services, and 2) the efficacy of an enhanced counseling intervention for helping Spanish-speaking smokers quit.
MATERIALS AND METHODS Participants and Procedures Adio´s al Fumar was a 2-group randomized clinical trial evaluating a smoking cessation intervention. Eligibility criteria included calling the NCI’s South Central CIS office to request smoking cessation help in Spanish, currently living in Texas, age at least 18 years, and self-identification as a current smoker. Participants were Spanish-speaking smokers recruited from several locations in Texas (Houston, San Antonio, El Paso, and the Rio Grande Valley). Paid media were used to increase awareness of the Spanish-language smoking cessation services offered by the CIS. Media included radio (Spanish stations only), newspapers (both English and Spanish), television (Spanish stations only), and direct mailings targeted to households with Spanish surnames. Data were collected for all the media-related costs of increasing the reach of the CIS Spanish-language smoking cessation services, so that cost-effectiveness analyses could be conducted. Those data are beyond the scope of the current article and will be described in a future report. Participants were enrolled from August 2002 to March 2004. There were 355 callers during the study period. All callers received the standard CIS smoking cessation counseling service at the time of call. At the conclusion of the initial call to the CIS, callers were offered the opportunity to participate in Adio´s. Of the 355 callers, 297 were eligible, consented to participate, and were randomized (84% participation rate). Of the 58 callers who did not participate, 28 chose not to participate, 3 did not meet eligibility criteria, 19 could not be reached to complete the baseline assessment, and 8 did not complete the baseline assessment. Callers who agreed to participate in the study were contacted within 1 week of their initial call to the CIS to complete a verbal, audiotaped informed consent and a baseline assessment. Informed consent was obtained from all participants. Participants were randomized at the completion of the baseline assessment call to receive either 1) standard counseling (SC) or 2) enhanced counseling (EC). Follow-up assessment calls were conducted 5 and 12 weeks after the baseline assessment call. All assessment and counseling calls were conducted in Spanish.
Standard and Enhanced Counseling SC consisted of the single CIS counseling session that had been delivered during the initial call to the CIS, plus an offer of Spanish language self-help materials that would be mailed to the participant if
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preferred. Self-help materials offered included Guia Para Dejar de Fumar (Guide to Quit Smoking),14 Datos y Consejos Para Dejar de Fumar (Facts and Advice to Quit Smoking),15 Usted Puede Dejar de Fumar (You Can Quit Smoking),16 and Cancer Facts.17 EC consisted of SC plus 3 additional proactive counseling calls. Additional calls occurred 1, 2, and 4 weeks after the initial call to the CIS. EC was delivered by 4 counselors, 2 from the CIS and 2 from the research team. The content of counseling, session length, and treatment duration were based on evidence presented in the U.S. Public Health Service’s Treating Tobacco Use and Dependence Clinical Practice Guideline.5 This approach focuses on what has been called ‘‘practical counseling’’ and on intra- and extratreatment social support. For example, practical counseling includes the identification of triggers to smoke and high risk situations, as well as coping strategies for dealing with those situations. Intratreatment social support includes the provision of encouragement by the counselor, whereas extratreatment social support includes assisting the participant in strategies for obtaining social support in their natural environment. Motivational enhancement techniques derived from motivational interviewing were also included.18 EC calls averaged 16 min (SD ¼ 6.1) for the week 1 call, 15 min (SD ¼ 5.5) for the week 2 call, and 14 min (SD ¼ 4.9) for the week 4 call. In addition to being delivered in Spanish, EC was culturally tailored. For example, the importance in Hispanic culture of respeto, simpatia, familismo, and personalismo (i.e., respect, pleasant and agreeable, family, and positive social relationships respectively) were incorporated into the counseling approach.19 The counseling protocol was extensively and repeatedly reviewed by Hispanic study staff from various countries of origin (i.e., Mexico, Argentina, Colombia) and revised as necessary to ensure that the approach was culturally appropriate across countries of origin. Areas of concern were resolved by consensus. Counselors as well as assessment staff were trained to use courteous and professional language, to use formal titles unless invited to do otherwise, to take the time necessary to develop rapport, to listen and reflect, to avoid being ‘‘pushy,’’ and to express appreciation and thanks.
Measures Demographic variables Demographic measures included age, sex, years of education, marital status, employment status, household income, insurance status, ethnicity, immigrant status, and language spoken at home. Several variables were dichotomized: marital status (married vs. not
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married), employment status (employed vs. not employed), household income ($20,000 vs. >$20,000), insurance status (health insurance vs. no health insurance), immigrant status (immigrant vs. not an immigrant), and language spoken at home (only Spanish vs. not only Spanish). Ethnicity was initially categorized as Mexican, Cuban, Puerto Rican, South American, Central American, Spaniard, or Other, and later dichotomized as Mexican versus all others, because of lesser numbers in the other categories.
Tobacco-related variables Tobacco-related variables included number of cigarettes smoked per day, minutes to the first cigarette after waking, times quit for 1 day during the past year, intent to quit in the next 30 days (yes vs. no), smoked in the previous 24 hours (yes vs. no), and the Fagerstrom Test for Nicotine Dependence (FTND), a widely used 6-item questionnaire that measures tobacco dependence.20 Minutes to the first cigarette after waking was dichotomized as 60 min versus >60 min. Smoking abstinence Point prevalence abstinence (self-report of no smoking during the previous 7 days) at the 5- and 12week assessments served as the primary outcomes. Data Analyses Initial analyses compared the EC and SC groups on the demographic and tobacco-related variables using a x2 test for categorical variables and a t test for continuous variables. Because the primary outcome (abstinence) includes repeated measures (weeks 5 and 12) that are correlated within subjects, the data analytic approach utilized generalized linear mixed model regression, which can handle nested designs and repeated measures with various correlation structures.21,22 Generalized linear mixed modeling (GLMM) is a flexible analytic approach widely used in health and social sciences research.23 A tradition in smoking cessation research has been to code all missing outcome data as not abstinent (i.e., smoking). Because not all participants lost to follow-up are smoking, this strategy can introduce bias and error, particularly when the proportion of missing data is large.24 An advantage of GLMM is that it is well-suited to handling missing data. Therefore, the analyses did not impute values for missing abstinence data. Two main analyses were used to examine treatment efficacy. Both analyses controlled for the effects of time (i.e., follow-up visit). The first analysis did
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TABLE 1 Participant Characteristics at Baseline
Demographics Age, y Sex, % men Years of education Marital status, % married Employment status, % employed Household income, % 60 min Times quit for 1 day in past year Intent to quit in the next 30 days, % yes Smoked in past 24 hours, % yes Fagerstrom test for nicotine dependence
Enhanced counseling (n 5 149)
Standard counseling (n 5 148)
P
41.4 (11.1)* 55.7 10.9 (4.1)* 68.5 50.7 56.6 74.6 67.8 93.2 59.1
40.8 (11.8)* 54.7 10.8 (3.9)* 66.7 49.3 54.4 79.1 65.5 94.6 64.2
.69 .87 .77 .74 .97 .70 .30 .68 .64 .36
10.5 (8.1)* 45.5 3.8 (9.9)* 96.0 84.6 7.0 (1.7)*
10.2 (8.7)* 51.7 3.3 (8.2)* 97.6 85.1 7.0 (1.6)*
.73 .37 .79 .47 .89 .88
* Values in parentheses are standard deviations.
not control for any covariates other than time, whereas the second analysis controlled for baseline demographic (age, sex, education, marital status, employment status, household income, insurance status, ethnicity, immigrant status, language spoken at home) and tobacco-related variables (cigarettes per day, minutes to first cigarette, time quit in past year, intend to quit in next 30 days, smoked in past 24 hours, and the FTND). To evaluate whether treatment effects differed for subgroups of participants, an additional set of analyses examined separately the interaction of treatment with each of the demographic and tobacco-related variables.
RESULTS Participants As noted previously, 297 of the 355 callers were eligible, consented to participate, and were randomized, resulting in an 84% participation rate. Participant characteristics by treatment group are shown in Table 1. Participants tended to be in their early 40s, were slightly more likely to be men, about two thirds were married, and half were employed. Participants tended to be of low socioeconomic status (SES). Average educational level was less than a high school degree, more than half had total household incomes of less than $20,000, and more than three fourths had no insurance coverage of any kind. About two thirds of the participants were of Mexican ethnicity/
origin, almost 95% were immigrants, and 60% spoke only Spanish at home. With respect to tobacco-related characteristics, participants smoked an average of 10 cigarettes per day, displayed relatively strong nicotine dependence as indexed by the FTND, and had made an average of 3.5 quit attempts in the previous year (Table 1). Approximately half the participants smoked within an hour of waking, over 95% intended to quit within the next 30 days, and 85% had smoked in the previous 24 hours.
Reach In the 18 months before the start of the study, a total of 7 people from Texas called the South Central CIS Spanish-language line requesting help for smoking cessation, for an average of 0.39 calls per month. In the 20-month study period, there were 355 calls, or an average of 17.8 calls per month. Thus, the reach of the CIS’s Spanish-language line increased more than 45-fold with respect to average calls/month. Follow-Up Rates and Counseling Dose Follow-up rates were 87% for the week 5 assessment and 80% for the week 12 assessment. There were no differences between groups in follow-up rates. With respect to the EC counseling calls, 97% of the EC participants received the week 1 call, 89% received the week 2 call, and 88% received the week 4 call. In
Smoking Cessation Among Hispanics/Wetter et al.
FIGURE 1. Abstinence rates by treatment group at the 5-week and 12week follow-up.
addition, 83% of EC participants received all 4 counseling calls (including the initial CIS call), and 92% received 3 out of 4 counseling calls.
Treatment Efficacy Point prevalence abstinence (self-report of no smoking during the previous 7 days) across the 5- and 12week assessments served as the primary outcome. Abstinence rates for EC versus SC at the 5- and 12week follow-up time points are shown in Figure 1. Controlling only for time, the effect of treatment (EC vs. SC) approached significance (OR ¼ 2.4, P ¼ .077). The treatment effect, however, became significant after controlling for demographic and tobaccorelated variables (OR ¼ 3.8, P ¼ .048). Treatment did not interact with any of the demographic or tobaccorelated variables, indicating that the effects of treatment did not differ across subpopulations.
DISCUSSION Adio´s al Fumar was successful in increasing the reach of the NCI’s CIS Spanish-language smoking cessation services by using paid media. CIS call volume for Spanish-language assistance with smoking cessation increased from an average of