Effectiveness of health education to increase screening for cervical cancer among eastern-band Cherokee Indian women in North Carolina.

BACKGROUND: The North Carolina Native American Cervical Cancer Prevention Project was a 5-year, National Cancer Institute-funded trial of health education designed to increase screening for cervical cancer among Native-American women in North Carolina. PURPOSE: This study was conducted to evaluate the effectiveness of this education program in the Eastern-Band Cherokee target population. METHODS: Cherokee tribal lands were mapped and all households (N = 2223) were listed to ensure maximum coverage of the eligible population (women, aged 18 years and older, who were enrolled tribal members). Eligible women were identified by the use of a brief questionnaire administered to an adult member of the household. Of the 1279 households with eligible women, 1020 (79.8%) agreed to participate. The intervention was an individualized health education program delivered by female Cherokee lay health educators. The participants were randomly assigned to receive or not to receive the intervention (i.e., to program and control groups, respectively) by use of the Solomon Four-Group design. Data were collected in face-to-face interviews conducted in the participant's home. Of the 996 women who were ultimately enrolled, 540 were randomly assigned to receive a pretest (preintervention) interview that involved administration of a 96-item questionnaire designed to collect data on knowledge, intentions, and behaviors related to cervical cancer; of these 540 women, 263 were randomly assigned to receive the education program. The remaining 456 women did not receive the pretest, but 218 were randomly assigned to receive the education program. Six months after receiving the education program, the women in all four groups were administered a post-test that was identical to the pretest. Logistic regression was used to assess the effects of the pretest and the educational program. All P values resulted from two-sided statistical tests. RESULTS: Eight hundred and fifteen (81.8%) of the 996 participants completed the post-test interview. The remaining 181 women who were lost to follow-up were evenly distributed among the four study groups. At the post-test, 282 (73.2%) of the 385 women who received the education program reported having had a Pap smear following the intervention, compared with 275 (64%) of the 430 control subjects. Women who received the education program were more likely to answer all knowledge items correctly on the post-test (odds ratio [OR] = 2.18, 95% confidence interval [CI] = 1.08-4.39) and to report having obtained a Pap smear in the past year (OR = 2.06, 95% CI = 1.14-3.72) than women in the control groups. CONCLUSION: Women who received the education program exhibited a greater knowledge about cervical cancer prevention and were more likely to have reported having had a Pap smear within the past year than women who did not receive the program.

Megestrol acetate versus tamoxifen in advanced breast cancer: 5-year analysis--a phase III trial of the Piedmont Oncology Association.

One hundred thirty-eight patients with recurrent or metastatic breast cancer were randomized to receive megestrol acetate 40 mg orally four times daily or tamoxifen 10 mg orally twice a day. Upon treatment failure patients were crossed over to the alternate treatment. Eligibility required that either the estrogen receptor (ER) or progesterone receptor (PR) be positive or that both values be unknown, and that the patients be at least 2 years post-spontaneous menopause or over 50 years of age. Pretreatment characteristics including performance status (PS), disease-free interval (DFI), receptor status, and prior treatment were similar for both groups. Only three patients had previous hormonal therapy while one third had prior chemotherapy. Objective response was determined using strict International Union Against Cancer (UICC) criteria. Seventeen of 61 patients achieved complete response (CR) or partial response (PR) on megestrol (28%) while 20 of 64 patients achieved CR or PR on tamoxifen (31%). Responses of skin and bone lesions were similar for both agents; however, more patients with visceral disease responded to tamoxifen. Response did not correlate with the level of ER or PR but was correlated with age. Both unadjusted and adjusted analysis of time to progression and adjusted analysis (for pretreatment variables) of survival showed significant differences favoring tamoxifen. Six of 44 patients (14%) crossed from megestrol to tamoxifen achieved CR or PR while only two of 38 patients (5%) crossed from tamoxifen to megestrol achieved response. Only one of the original patients randomized to megestrol remains on study, while 12 patients still remain on tamoxifen. These data indicate similar response rates for megestrol and tamoxifen; however, time to progression and overall survival significantly favor tamoxifen when used as first-line therapy in this trial.

Amelioration of vincristine neurotoxicity by glutamic acid.

Neurotoxicity is the principal limiting side effect of the widely used antitumor agent, vincristine. Following evaluation of glutamic acid as a potential modifier of vincristine toxicity in preclinical studies in mice and a preliminary clinical trial, a prospective, double-blind, placebo-controlled, randomized trial was conducted by the Piedmont Oncology Association. Of 87 patients entered into the study, 84 were evaluable, including 42 patients who were randomly assigned to receive vincristine 1.0 mg/m2 weekly for six doses and 42 patients who were assigned to receive glutamic acid 500 mg orally three times daily plus vincristine. The following neurotoxic signs and symptoms were evaluated before each dose of vincristine: reflex changes, paresthesias, constipation, strength, and mental changes. Loss of the Achilles tendon reflex, an objective parameter, was noted in 19 percent of patients receiving glutamic acid and 42 percent of control subjects (p = 0.03). Development of moderate to severe paresthesias, a subjective parameter, occurred in 19 percent of the glutamic acid group and 36 percent of the placebo group (p = 0.09). Overall moderate neurotoxicity (6 units or more), determined by adding the grade of each neurotoxic parameter for the weekly clinic visit in which maximum neurotoxicity occurred, was observed in 21 percent of patients receiving glutamic acid and 43 percent of those in the control group (p = 0.04). Hematologic and gastrointestinal side effects occurred with similar frequency in the two groups. The administration of glutamic acid has decreased vincristine-induced neurotoxicity without any attendant side effects.

Race differences in infant mortality from endogenous causes: a population-based study in North Carolina.

This study examines the associations between race, birth weight, and mortality from endogenous causes for all singleton births born in 1984-1987 in a 20-county region of North Carolina. A more detailed analysis of preterm low birth weight infants examines these associations according to the proximate medical causes (medical etiology) of the preterm birth. Overall, black infants were found to have approximately twice the mortality risk of white infants. Most of the excess black mortality risk is explained by the larger proportion of black infants born at lower birth weights. The pattern of race differences in infant mortality by birth weight generally replicates the results of earlier studies, but the relative risk ratios within specific birth weight categories are smaller than previously reported. Among preterm low birth weight infants, the association between race and endogenous mortality differs within categories of medical etiology. The mortality risk is the same for black and white infants born preterm due to premature rupture of the membranes (PROM), lower for black infants born preterm due to medical problems, and higher for black infants born preterm due to idiopathic premature labor (IPL).

Errors in reporting cervical screening among public health clinic patients.

This study examines women's knowledge of whether or not they had a cervical smear as part of their examination in a public health clinic for sexually transmitted diseases. Usable interviews were completed with a cluster sample of 318 women. Approximately 56% of the women were not able to correctly report if they had a cervical smear; and 90% of the erroneous responses consisted of reporting a cervical smear when none actually was done. Young women and single women were more likely to report incorrectly. Overall, the results suggest considerable error in overreporting cervical screening in this population.

Marrow fibrosis and multiple myeloma.

A retrospective review of pretreatment bone marrow material from 297 patients diagnosed and treated for multiple myeloma (MM) at a single institution during a 22-year period (1961-1982) was performed in order to assess the frequency and significance of associated simple marrow fibrosis (SMF). The presence of SMF was suspected in the hematoxylin and eosin-stained sections in 48 of the 297 cases and was confirmed by reticulin stains in 26 (8.8%) cases, with seven of these also showing collagen on trichrome stain. However, the literature on MM documents little recognition of this association. SMF is often responsible for inadequate marrow aspirates yielding spurious or inconclusive results. Thus, bone marrow trephine biopsies may be required to histologically confirm the diagnosis of MM when there is concurrent SMF.

A randomized trial of nurse intervention to reduce preterm and low birth weight births.

OBJECTIVE: To test the effect of telephone calls from registered nurses to low-income pregnant women on the rates of low birth weight (LBW) and preterm births. METHODS: A total of 1554 women receiving prenatal care in a public clinic who met study criteria and who consented were assigned randomly to intervention and control groups. Women in the intervention group received telephone calls from a registered nurse, one or two times weekly from 24 weeks' through 37 weeks' gestation. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated. RESULTS: Low birth weight rates were 10.9% in the intervention group and 14.0% in the control group (RR 0.75; 95% CI 0.55, 1.03; P = .072). For gestational age less than 37 weeks, rates were 9.7 in the intervention group and 11.0 in the control group (RR .87; 95% CI 0.62, 1.22; P = .415). In the subgroup of low-income black women 19 years of age and older, a statistically significant difference was found in preterm birth rates before 37 weeks (8.7% in the intervention group versus 15.4% in the controls [RR 0.56; 95% CI 0.38, 0.84; P = .004]). CONCLUSION: There was no difference in LBW or preterm births between intervention and control groups in the total sample. In a secondary analysis of black subjects 19 years of age and older, there was a significant difference in preterm birth rates.

Continuous intravenous infusion of vinca alkaloid using a subcutaneously implanted pump in a canine model.

A major drawback of infusions of the vinca alkaloids is the lengthy period of hospitalization which is often required for this novel technique of cancer therapy. A potentially useful system to deliver outpatient therapy has been investigated in a preclinical study. A self-contained infusion pump powered by a self-charging fluorocarbon system has been implanted SC in three dogs. The performance of two pumps which had been factory-calibrated to deliver 2.5 and 4.5 ml/day, respectively, was evaluated during 22 infusions of the vinca alkaloids (vincristine, 7; vinblastine, 7; and vindesine, 8). Infusions were given over a 5- to 7-day period and were repeated at 3-week intervals. No malfunctioning of the pumps occurred in over 500 cumulative days of use. The flow rates of the pumps were quite stable except in one animal whose increased flow rate was probably a consequence of fever due to self-induced inflammation about the pump pocket. No local or distant tissue reactions to the pump were observed. Decomposition of vincristine and vinblastine in the infusate at the end of 5- or 7-day infusions was minimal as determined by high-pressure liquid chromatography. The amount of decomposition of vindesine in the infusate was variable. Steady-state concentrations of vincristine during infusion were always greater than 10(-9) M, and were similar to those previously determined in our clinical infusion trials using a dosage of 0.5 mg/m2/day. Clinical evaluation of this system for prolonged infusions of vincristine and other vinca alkaloids appears to be warranted.

CCNU in combination chemotherapy for advanced histologically unfavorable non-Hodgkin's lymphoma.

During a 3-year period 39 evaluable patients with stage III and IV non-Hodgkin's lymphomas and unfavorable histologies were treated with a unique chemotherapeutic regimen based on a modified CHOP combination to which was added the nitrosourea, CCNU. Complete response was observed in six of 15 (40%) patients with diffuse poorly differentiated lymphocytic lymphoma (DPDL), four of 11 (36%) with diffuse mixed histiocytic lymphocytic (DML), and seven of 13 (54%) with diffuse histiocytic lymphoma (DHL). Of the 17 patients who achieved complete response, nine (53%) have remained continuously disease-free for greater than 2.5 years (2.7-4.1 years) from the onset of therapy: four of six with DPDL, two of four with DML, and three of seven with DHL. Median survival was 18.9 months for all patients, 18.9 months for those with DPDL, 17.4 months for those with DML, and 9.7 months for those with DHL. The median survival has not been reached for patients who attained a complete response, and will exceed 3.3 years. Central nervous system relapse was observed in three patients. In general, toxicity was moderate and consisted primarily of leukopenia, nausea, vomiting, and neurotoxicity. There were no drug-related deaths. The addition of CCNU to a modified CHOP combination resulted in an effective, generally well-tolerated out-patient regimen. However, it did not appear to decrease the rate of CNS relapse or improve current treatment results observed with other adriamycin-containing regimens for similar patients.

Lack of potentiation of vincristine-induced neurotoxicity by VP-16-213.

Due to a recent alarming report suggesting that the severe neurotoxicity observed following treatment with a multiagent chemotherapy regimen might be due to the interaction of vincristine and VP-16-213, the neurologic toxicity data from a randomized trial conducted by the Bowman Gray School of Medicine and the Piedmont Oncology Association in small cell carcinoma of the lung have been analyzed. Of 102 patients evaluable for toxicity, 50 were treated with a combination of cyclophosphamide, adriamycin, and vincristine (CAV) and 52 received this regimen plus VP-16-213. Vincristine dosage was the same in both arms of the study. When analyzed by severity, neurologic complications were similar in both treatment groups: Grade 1-2 neurotoxicity occurred in 55% of patients on both arms and grade 3-4 neurotoxicity was observed in six (12%) patients on the CAV arm and four (8%) on the CAV-VP-16-213 arm. Addition of VP-16-213 to vincristine did not potentiate vincristine-induced neurotoxicity when administered in this dose-schedule relationship.

Vincristine by continuous infusion in refractory breast cancer: a phase II study.

Eighteen patients with advanced refractory breast carcinoma were treated with vincristine (VCR), 0.5 mg I.V. bolus followed by continuous I.V. infusions of 0.25 mg/m2/day for 5 days every 3 weeks. The daily dose of VCR was infused in 1000 ml D5W to which was added hydrocortisone 50 mg and heparin 3000 U. Patients received from one to six courses (mean 2.3 courses). No objective responses were observed. Stable disease was noted in five patients who had skeletal metastases only. Disease progression occurred in the remaining 13 patients, 10 of whom had received prior VCR by bolus injection. The principal toxicity consisted of constipation without ileus and hyporeflexia-paresthesias. Vincristine, administered by continuous I.V. infusion according to this dose and schedule does not appear to be effective in the treatment of patients with advanced refractory breast cancer.

Development of a community cancer education program: the Forsyth County, NC cervical cancer prevention project.

The authors outline the development and implementation of a public health education program for cervical cancer screening among black women in Forsyth County, NC. The educational program includes distributing electronic and printed information media messages, a program of direct education for women, and providing information on current issues in cervical screening to primary-care physicians. Program development was based on social marketing principles, the PRECEDE model, and the communication-behavior change (CBC) model. Since a true experimental design was not feasible, program evaluation is based on several complementary quasi-experimental designs. Analysis of baseline data indicate that the county where the intervention is taking place, and the control county, are similar with respect to both demographic characteristics and the current level of screening activity. Preliminary results indicate that the program has been successful in raising women's level of awareness of cervical cancer and cervical screening.

Sample registration in India.

India's ad hoc sample registration scheme for obtaining current estimates of rural birth and death rates for the whole country is being implemented quite rapidly. Five states have 140 sample units, and eleven states will have from 20 to 100 units in the study depending upon the stage of implementation by March, 1967.Essential elements of the project for each unit are: (1) continuous registration of vital events by a paid part-time local enumerator, (2) a six-month household survey to detect births and deaths which occurred during the previous six months, and (3) matching events from registration and surveys and field recheck of unmatched events to obtain the "best" count of real number of events. Preliminary results in a non-random sample indicate that the crude birth and death rates are around 37.1 and 15.7 per 1,000, respectively, for India's rural population, but these probably will be found to be on the low side.Most of the problems of implementation are operational or administrative rather than statistical: (1) For various reasons, some states are slow in agreeing to assume financial and other responsibilities for the scheme. (2) In many states, even after the scheme has been accepted, there are delays in recruiting the staff, training, and so forth. (3) The most serious problem in the whole project is maintaining control of field operations well enough at each stage to insure that prescribed instructions and methodology are being followed.Experience in India indicates that staged implementation of such projects is highly desirable when trained staff are limited. There still are a number of methodological problems which must be tested as the sample registration evolves. Sample registration is one of the first steps in the Indian program to. develop an adequate vital statistics system. Exploratory studies to measure completeness of civil registration are being done now in an effort to develop means of using civil registration data alone for measurement of vital rates.

Report on matching procedures of a dual record system in the southern Philippines.

There are generally three stages to the development of rules for matching vital events data from two sources covering the same population: (a) establishing a set of "true" matches and nonmatches; (b) determining the best tolerance limits for each single characteristic which might be used in matching; and (c) experimenting to determine the set or sets of characteristics and the weights to be used in classifying a pair of records as matched or nonmatched. Specific examples, based on early matching experiments with data from the dual record system of the Mindanao Center for Population Studies (MCPS), are presented. Successive application of different sets of characteristics (differential valence rule) to the remaining unmatched events produced an acceptable rule for matching in this study.

The Forsyth County Cervical Cancer Prevention Project--I. Cervical cancer screening for black women.

The Forsyth County Cervical Cancer Prevention Project was a 5 year National Cancer Institute-funded community-based public health education program implemented to address the problem of excess mortality from cervical cancer among black women in Forsyth County, North Carolina. The intervention was a community-based public health education program that included mass media, direct education workshops, and provision of education on cervical cancer and screening to health care providers. The intervention was implemented from November 1988 to September 1991. Evaluation of the community intervention used a quasi-experimental design, with Forsyth County, North Carolina, receiving the program and Durham County, North Carolina, serving as the control. Comparison of pre- and post-intervention telephone survey data revealed that, overall, awareness of cervical cancer and the Pap smear increased. Knowledge, attitudes and behaviors showed little change, considering those interviewed in aggregate. Among women defined as high-risk (elderly, low socioeconomic status, public health clinic patients and/or those who do not receive regular care), a significant trend toward greater participation in screening was detected for the 6 month period following the intervention. These results suggest that awareness of cervical cancer can be increased by public health education, but that the additional attention coming to patients through the actions of health care providers and health care delivery systems may supply the additional input needed to produce behavior change.

The Forsyth County Cervical Cancer Prevention Project--II. Compliance with screening follow-up of abnormal cervical smears.

The Forsyth County Cervical Cancer Prevention Project was a community-wide cancer education program to address the problem of cervical cancer incidence and mortality among minority women in Forsyth County, North Carolina. This paper reports program results with regard to increasing compliance with follow-up for abnormal cervical smears. An analysis of trends prior to and after implementation of the educational program was conducted in one private and two public health primary care clinics to provide an assessment of impact of the project in improving compliance with follow-up among black women. A similar analysis also was conducted for white women. The results of medical record reviews of follow-up procedures for 878 abnormal cervical smears suggested a modest program effect among black women. The percentage of black women who returned for follow-up and treatment of an abnormal cervical smear significantly increased during the time the program was in effect. The trend analysis further indicated that the decline did not begin prior to the intervention period and was maintained throughout the duration of the intervention. No significant change in the percentage who returned for follow-up was found for white women.