Willingness to participate in clinical trials among African Americans and whites previously exposed to clinical research

The objective of this study was to identify racial differences in willingness to participate in a population with previous exposure to clinical research. A survey instrument was administered to community-dwelling whites and African Americans who were voluntarily receiving a lay research and health education newsletter from a local Boston geriatric clinical research institution. The survey instrument assessed willingness to participate in 3 hypothetical clinical trials (diet trial for obesity, medication trial for hypertension [HTN], chemotherapy trial for cancer). Surveys were received from 473 whites and 279 African Americans (53% response rate) with mean age 74 (SD +/- 9). In multivariate models, race was not significantly related to willingness to participate in the multivariate models for any of the 3 trials. Previous trial participation was related to a higher odds of willingness to participate in the diet trial only (OR 1.8, 95% CI 1.2, 2.6). Lower levels of trust in one's primary care physician were associated with a lower odds of willingness to participate in clinical trials for the diet and HTN trials (OR 0.5, 95% CI 0.3, 0.8 and OR 0.6, 95% CI 0.3, 0.9, respectively). These findings suggest that, within populations previously exposed to clinical research, African Americans are no less willing to participate in clinical trials compared to whites.     

Participant-centered analysis in complementary and alternative medicine comparative trials

Participant-centered analysis involves applying the customary methods of statistical decision making at the level of the individual research participant. Consequently, each individual is declared a responder who benefited, a nonresponder, or possibly a responder who was harmed, using intensively collected data that were specific to that individual. There are several implications of the participant-centered approach. More data actually relevant to the important outcome need to be collected on individuals. The study results can be summarized in a simple table of responders/nonresponders by treatment group, and probabilities of true response can be estimated. The actual nature of the data collected and the statistical models used to analyze them drop into the background. Finally, production of individual-level decisions permits standard statistical approaches to be applied to the issue of which modality should be recommended for which person, instead of focusing on average effects and which modality should be recommended for everyone.     

The use of complementary and alternative medicine among pediatric patients

The overall objective of this research was to obtain information through the use of open-ended interviews, about the diagnosis and treatment of children who had cancer. The interviews, completed with 29 parents whose children had been diagnosed with cancer within the previous 5-year period, were designed to allow mothers and fathers to share their experiences about childhood cancer. From this process, many salient issues were identified by the interviewed parents, one of these issues being that of complementary and alternative medicine (CAM) use among children being treated for cancer. Analysis of the CAM theme resulted in the identification of the following subthemes: (1) parents' opposition to CAM utilization; (2) parents' support of CAM use with their children with cancer; and (3) physicians' views of CAM as perceived by parents. Implications for the use or nonuse of CAM among pediatric populations will be discussed.     

Ethnic differences in complementary and alternative medicine use among cancer patients

OBJECTIVES: This study estimated the prevalence of complementary and alternative medicine (CAM) use and its relation to quality of life (QOL) among cancer patients from diverse ethnic backgrounds. Given the ethnically diverse population in Hawaii, we hypothesized that CAM use may be related to the ancestry and the cultural heritage of cancer patients. DESIGN AND SETTING: Participants for this mail survey were identified through the Hawaii Tumor Registry, a state-wide population-based cancer registry. SUBJECTS: Patients with invasive cancer diagnosed 1995-1996. Of the 2,452 questionnaires received, 1,168 (47.6%) were returned. OUTCOME MEASURES: Prevalence of CAM use and QOL measures. RESULTS: One in four respondents reported at least one CAM therapy since cancer diagnosis. CAM use was highest among Filipino and Caucasian patients, intermediate for Native Hawaiians and Chinese, and significantly lower among Japanese. Some ethnic preferences for CAM followed ethnic folk medicine traditions, e.g., herbal medicines by Chinese, Hawaiian healing by Native Hawaiians, and religious healing or prayer by Filipinos. CAM users reported lower emotional functioning scores, higher symptom scores, and more financial difficulties than nonusers. CONCLUSIONS: This study detected ethnic differences in CAM use, in particular a low use among Japanese patients, and supports the importance of cultural factors in determining the frequency and type of CAM therapies chosen. Consideration of patients' cultural heritage may facilitate communication between physicians and patients about CAM with the goal to achieve optimal cancer care.     

Use of complementary and alternative medicine in patients suffering from primary headache disorders

Complementary and alternative medicine (CAM) is increasingly common in the treatment of primary headache disorders despite lack of evidence for efficacy in most modalities. A systematic questionnaire-based survey of CAM therapy was conducted in 432 patients who attended seven tertiary headache out-patient clinics in Germany and Austria. Use of CAM was reported by the majority (81.7%) of patients. Most frequently used CAM treatments were acupuncture (58.3%), massage (46.1%) and relaxation techniques (42.4%). Use was motivated by 'to leave nothing undone' (63.7%) and 'to be active against the disease' (55.6%). Compared with non-users, CAM users were of higher age, showed a longer duration of disease, a higher percentage of chronification, less intensity of headache, were more satisfied with conventional prophylaxis and showed greater willingness to gather information about headaches. There were no differences with respect to gender, headache diagnoses, headache-specific disability, education, income, religious attitudes or satisfaction with conventional attack therapy. A higher number of headache days, longer duration of headache treatment, higher personal costs, and use of CAM for other diseases predicted a higher number of used CAM treatments. This study confirms that CAM is widely used among primary headache patients, mostly in combination with standard care.     

Use of complementary and alternative medicine among Dominican emergency department patients

This small, pilot study examined presenting complaint, brief health history, use of complementary and alternative medicine (CAM), and sociodemographic characteristics, among patients attending the emergency department (ED) of a large urban hospital. The sample (n = 50) was primarily Dominican and of low socioeconomic status. Almost half had used CAM for their presenting complaint or another health problem during the past year, most commonly in the form of medicinal plants made into herbal teas. CAM users were more likely to be female, longer-term residents of the United States, and to have also used religious practices for health problems. Subjects who had used CAM for any problem other than the presenting complaint during the past year rated its effectiveness higher than subjects who had used CAM for their presenting complaint. In conclusion, it is likely that a significant proportion of Dominican ED patients use CAM, suggesting that they should be asked about their CAM use during triage.     

Knowledge and attitudes regarding clinical trials and willingness to participate among prostate cancer patients

BackgroundEnrollment of minorities in clinical trials remains low. Through a California population-based study of men with early stage prostate cancer, we examined the relationships between race/ethnicity and 1) attitudes, 2) knowledge and 3) willingness to participate in clinical trials.MethodsFrom November 2011–November 2012, we identified all incident cases of prostate cancer in African American, Latino, and Asian American men ages 18–75 years, and a random sample of white men diagnosed in 2008, through the California Cancer Registry, living within 60 miles of a site offering ≥ 1 clinical trial. Participants completed a 30-min telephone interview in English, Spanish, or Chinese. In this cross-sectional population-based study, multivariable logistic regression was used to estimate associations between race/ethnicity and 1) attitudes, 2) knowledge and 3) willingness to participate.ResultsOf 855 participants, 52% were ≥ 65 years, 42% were white, 24% Latino, 19% African American and 15% Asian American. The majority (81%) had medium-to-high health literacy. Compared to non-Latino white men, African American men were less likely to have above average knowledge of clinical trials (OR = 0.55; CI = 0.35–0.86), as were Asian American (OR = 0.55; CI = 0.33–0.93) and Latino men (OR = 0.30; CI = 0.18–0.48). There were no racial/ethnic differences in willingness to participate. The attitude that “researchers are the main beneficiaries” was negatively associated with willingness (OR = 0.63; CI = 0.43–0.93); the attitude that “patients are the main beneficiaries” was positively associated with willingness to participate (OR = 1.57; CI = 1.07–2.29).ConclusionsMen with early stage prostate cancer are willing to take part in clinical trials and this willingness does not vary by race/ethnicity.     

Research on complementary and alternative medicine using randomized controlled trials

In 1998, the National Institutes of Health (NIH) formed the National Center for Complementary and Alternative Medicine (NCCAM) from what had formerly been the Office of Alternative Medicine. This presentation opens with a brief discussion on the history of the NIH and the development of CAM at the NIH before moving on to the work of the NCCAM. The NCCAM is moving toward an integration of CAM therapies into conventional medicine, when there is evidence for the value of CAM. One of twenty-five institutes or centers at the NIH, the NCCAM looks at evidence-based medicine and public health. In this context, "public health" means educating the public about its health. The NCCAM supports training to conduct research and plays an important role in disseminating information to the public and to health providers about what works and what is safe. This evolves into the concept of evidence-based medical and public-health practices, that is, making decisions on the basis of evidence from scientifically rigorous studies that are sufficiently large to provide a confident estimate of biologically and medically important benefits and risks. In the hierarchy of generating scientific evidence, randomized controlled trials are considered the "gold standard." The NCCAM entertains proposals for studies that come spontaneously from investigators, or, upon identifying an existing need that is not being met by the investigative community, the NCCAM can initiate a request for proposals. Every proposal is subjected to a rigorous application and review process. Another possible step in the assessment of the evidence from clinical trials is to do a systematic analysis of several studies to bring together all the information that is available. Systematic reviews of smaller studies that individually might have an insufficient sample size can assist in making treatment decisions, but, importantly, they can lead the NCCAM in the development of future, definitive studies. Training to conduct research is especially important to CAM. This presentation outlines several approaches the NCCAM has to training (see http://nccam.nih.gov).     

Survey on the use of complementary and alternative medicine among patients with headache syndromes

The objective was to determine headache patients' knowledge, prevalence of use and perceived effectiveness of complementary and alternative medicine. Seventy-three patients with headache syndromes attending a head and neck pain clinic were interviewed using a standardized questionnaire. Alternative medical therapies were used by 85% of surveyed patients for the relief of their head pain. In 60%, the therapies were perceived to have a benefit. Almost 100% of the patients were familiar with one or more of the presented alternative treatments. Eighty-eight per cent perceived at least one of the complementary treatments to be an effective remedy for headache pain. Exposure to and interest in alternative treatments are common among patients with headache syndromes, despite the lack of scientific evidence of benefit and assessments of risks for many of the treatments. Neurologists and general physicians should be aware of the increasing role of alternative medicine in the healthcare system. There is still an urgent need for objective, integrative and critical research with regard to complementary and alternative medicine.     

Determinants of the degree of complementary and alternative medicine use among patients with cancer

OBJECTIVES: This study explored the use of complementary and alternative medicine (CAM) by degree of use (nonuse, light, moderate, and heavy) by patients with cancer as it relates to sociodemographic and disease characteristics, subjective well-being, and dissatisfaction with the health care system. Design and participants: One hundred and forty-three (143) patients with cancer of Asian, Caucasian, and Pacific Islander ethnicities originally recruited through the state-wide population-based Hawaii Tumor Registry and interviewed approximately 3 years postdiagnosis. OUTCOME MEASURES: This study introduced a multidimensional measure, degree of CAM use, to rank participants by quantity of CAMs used as well as frequency, intensity, and breadth of use. Predictor variables explored were sociodemographic variables, disease site, quality-of-life measures, satisfaction with conventional treatment and physicians, satisfaction with medical information, and perceived severity of illness. RESULTS: Heavier CAM use was related to being female, Caucasian, having more education, having breast cancer, and having greater symptoms of nausea and vomiting. Heavier use was also associated with lower doctor satisfaction and a greater perception of disease severity. Sociodemographic and clinical variables accounted for the largest proportion of the variance in degree of use, but subjective well-being and health care satisfaction provided incremental increases in the variance explained. CONCLUSIONS: This study is one of few studies exploring predictors for the quantity or degree of use of CAM by patients with cancer. Understanding factors related to these patients' heavier or lighter CAM use has implications for health care offerings and cancer treatment decision-making.     

Use of complementary and alternative medicine among patients with cancer receiving outpatient chemotherapy in Taiwan

PURPOSE: The objectives of this study were to describe the prevalence and types of complementary and alternative medicines (CAMs) used among patients with cancer receiving outpatient chemotherapy in Taiwan. METHODS: This study was a cross-sectional survey. The study participants were 160 patients with cancer receiving outpatient chemotherapy at a medical center in northern Taiwan. RESULTS: The vast majority of the participants reported CAM use (n = 157, 98.1%). The two most common groups of CAM used were "biologically based therapies" (77.5%) and "mind-body interventions" (60.6%). Fifteen percent (15.3%) of patients took grapeseed and ginseng, which might affect the efficacy of some chemotherapy regimens. Fourteen percent (14.4%) of patients did not know the name of the herbs they took. The most commonly reported reasons for CAM use were to boost the immune system (55.4%) and relieve stress (53.5%). Approximately two thirds of patients (66.2%) had never informed their physicians of CAM use. CONCLUSIONS: This survey revealed a high prevalence of CAM use among patients with cancer receiving out-patient chemotherapy in Taiwan. The types of CAM used by patients with cancer in Taiwan differed from those in Western countries. Health professionals need to be cautious about the potential herb-drug interactions.     

Quality of life and complementary and alternative medicine use among cancer patients in Turkey

AimThe purpose of this study was to assess the relationships between quality of life and use of complementary and alternative medicine (CAM) among Turkish cancer patients.MethodsThis cross-sectional study was conducted in Istanbul University Institute of Oncology, Turkey. Two-hundred patients were invited and informed consent was obtained, however 179 cancer patients completed the study. The Patient Characteristics form, The Nightingale Symptom Assessment Scale and The Functional Assessment of Cancer Therapy Scale were used in the evaluation of the patients’ characteristics and quality of life.ResultsSome form of CAM had been used by 71.5% of the sample. Frequently used CAM methods appeared to be religious practices (68.2%) and only 37.4% of the patients used herbs. However, female patients, single patients, and individuals with metastatic disease and worse quality of life showed a tendency to use CAM more often. More than one-third of our patients began to use CAM immediately after being diagnosed with cancer and factors associated with CAM use varied according to the type of CAM. Although CAM use did not affect the patients’ quality of life, logistic regression analysis revealed that gender, type of cancer diagnosis and education level were important factors to be considered in different CAM therapies.ConclusionCAM use is common in cancer patients in Turkey. More discussion about CAM use should take place between patients and health professionals to inform the patients’ decisions.     

Survey of the use of complementary and alternative medicine among Turkish cancer patients

OBJECTIVES: To measure the frequency of use of complementary and alternative medicine (CAM) among patients with malignancy undergoing or following conventional treatment, to determine demographic characteristics associated with the use of CAM, and to find out how benefits, if any, were perceived by patients. DESIGN: A 35-item survey questionnaire administered to 305 return patients with malignancy. SETTING: Clinical wards of the Oncology and Haematology departments of Gülhane Military Medical Academy, Ankara, Turkey. METHODS: Questionnaire-based measures of demographics, motives, expectations and effects of using CAM, and types and reported perceived benefits of CAM practised on patients with malignancy. RESULTS: The majority of return patients (n = 186, 61.0%) used at least one CAM practice; and birthplace, educational status, and family type were significant factors in such behaviour. CONCLUSIONS: Patients with malignancy born in villages, having less education and living in large families were more likely to use folk medicine. More than half of those using CAM (n = 99, 53.2%) reported as benefits the feelings of either strengthening of the body, being in good psychological condition, or the disappearance of several symptoms.     

Prevalence of complementary and alternative medicine use among HIV patients for perceived lipodystrophy

BACKGROUND: Complementary and alternative medicine (CAM) use is common among some patients who test positive for human immunodeficiency virus (HIV). Changes in body-fat distribution can occur in some patients on prolonged highly active antiretroviral therapy. Currently, there are fewer effective treatments for the condition. Patients with lipodystrophy may be turning to CAM. OBJECTIVE: The objective was to investigate the prevalence and perceived benefit of CAM use for perceived body-shape changes among a cohort of HIV-positive patients. DESIGN/SETTING/SUBJECTS: We surveyed a cross-sectional convenience sample of 74 patients from urban and suburban HIV outpatient clinics in Baltimore, MD, who indicated concerns about body-shape changes. The survey instrument was developed based on validated questionnaires previously used in clinical trials and published work. RESULTS: CAM use including both supplements and visits to CAM providers was 74% in our study population. In multivariate analysis, users of CAM were more likely to be men (p = 0.016) and to have noticed bodyshape changes after taking HIV medications (p = 0.012). However, very few subjects reported using CAM specifically for lipodystrophy changes. CAM use was more commonly reported for "general health." CAM was primarily more conventional, such as multivitamins or minerals, but several subjects reported using meditation and/or prayer (38%), ginseng (Panax spp.) (3%), St John's wort (Hypericum perforatum) (1%), and acupuncture (1%). More conventional CAM, such as exercise, diet, and vitamins as well as meditation/prayer were perceived to be effective for lipodystrophy as well as for improving the overall sense of well-being. CONCLUSIONS: The rate of CAM use among the HIV-positive population is high and is primarily used to improve general health.