A Randomized Controlled Trial - Dissertation Example

A Randomized Controlled Trial Most women with signs indicative of a breast cancer diagnosis holdup presentation to their family doctor. Regardless of widespread measures to encourage an early/ timely detection of breast cancer, estimations reveal that 20 to 30 percent of women hang around for a period of 3 months prior to seeking help from an allied health professional (AHP), for the symptoms of breast cancer (Heisey et al., 2011). Studies further reveal that women with deferred presentation are reported to possess large tumors and thereby have diminished possibility of prolonged survival (Heisey et al., 2011). Numerous reasons are associated with the presentation delay to utilize health care services. The reasons involve psychological and social factors- that encompass the personal predispositions that cause a presentation delay to utilization of the health care system (Heisey et al., 2011). Research studies revealed that adherence to the recommendations for breast cancer post-treatment surveillance is less in African American women as compared to White survivors study by Thompson et al., (2009), revealed that by training African American women as lay health workers (LHWs), efficacy to focus on the intricacies of breast cancer recurrence and surveillance could be enhanced. The proposed study is a randomized controlled trial of a training method in order to improve the process of breast cancer referrals in allied health professionals (AHP). Problem Statement Breast cancer is one of the most common cancers prevailing in women across the world (American Cancer Society, Surveillance Research, 2011). An early detection is considered to enhance the survival rate of the patient, bringing back life to normalcy. The conventional justification and categorizations of delay in breast cancer are based on unsystematic realistic time shortages. Studies of breast cancer delay are based on patient and provider delay (American Cancer Society, Surveillance Research, 2011). A restructuring of its conventional conceptualization is necessary (American Cancer Society, Surveillance Research, 2011). The proposed study recommends a multidimensional representation of breast cancer delay stranded in data by means of randomized controlled trial of training method to improve the process of breast cancer referrals of symptomatic patients and bubbled in the assumption of illness behavior. Purpose of the study Delay in the process of breast cancer referrals is associated with the socio-cultural background, personality of the individual, which directly influences interpretation of symptoms, making-up a decision and social interaction followed by the support attained from allied health services. Breast cancer issue is integral and is responsible to bring fatal consequences, the study is designed to understand the varied magnitudes involved in the randomized controlled trial of training method involved in improving the process of breast cancer referrals. Key Terms: Decision-making processes, obstacles, recommendations, breast cancer, allied health professional (AHP), National Consortium of Breast Centers (NCoBC), health related quality of life (HRQoL), community health workers (CHWs), African American women (AAW). Significance Breast cancer is the most prevalent of all the malignancies across the world, characterized by early inception and diagnosis at the advanced stages, thereby generating the need to increase awareness in women to implement screening and decrease the rate of mortality (Kadivar et al, 2012). Considering the importance of imparting understanding and knowledge to women, an interdisciplinary group of medical and allied health professionals (AHPs), recognized as the National Consortium of Breast Centers (NCoBC), advocates the need of collaborative breast care (Gass et al., 2011). Most of the breast cancers are invasive or infiltrating type. Detection through breast examination and imaging needs to be further confirmed by microscopic examination of breast tissue for definitive diagnosis (Breast Cancer Facts & Figures 2011-2012; American Cancer Society, Surveillance Research, 2011). Considering the view of Wagner, (2010), a clinical breast radiologist, quality imaging equipments and highly motivated breast care interdisciplinary team play a vital role in incorporating policies for the success of improvement in breast care referrals. Female breast cancer incidence (2004-2008) and mortality rates (2003-2007) by race/ ethnicity and state by American Cancer Society, Surveillance Research (2011) for Ohio, reveals that Non-Hispanic White women displayed the breast cancer incidence rate to be 119.4 while the mortality rate was 25.9; African American women displayed incidence rate as 120.7 while the mortality rate was 34.5. Mammography is the screening procedure adopted for the detection of breast cancer (Breast Cancer Facts & Figures 2011-2012, American Cancer Society, Surveillance Research, 2011). Mammogram detects tumors at primitive stages to onset the treatment procedure. However, delay in undergoing the screening process may diminish the survival rate (Chatterjee et al., 2013). A comparative study carried out by Gullate, (2006), highlighted the fact that African American Women are 25 percent more likely to present with the breast cancer at later stages, moreover for 20 percent such cases the results are fatal in contrast to Caucasian women. The reasons attributed to delay in screening encompass poor access, lack of knowledge, socioeconomic aspects, religious and spiritual values, fatalism and fear. The research carried out by Gullate et al., (2010), revealed that the median postponement in time between self discovery of breast cancer symptom and seeking medical care was reported to be 5.5 months. Delay in medical attention is attributed to lack of education, unmarried or those who believe in disclosing to God only. It is evident that delay in seeking medical care for more than 3 months present women with advanced stages of breast cancer in contrast to women who approached medical or allied health professional within 3 months of symptom detection. The proposed study is important as health related quality of life (HRQoL) of breast care survivors reveal the importance of supporting and promoting care programs which are vital in psychosocial support followed by diagnosis (DiSipip et al., 2009). A study carried out by Easley and Miedema (2012), further emphasized the need of training nurses; as nurses play a central role in patient education especially during the process of rehabilitation, their findings emphasize the long-term sequelae in patient's referral to medical and allied health care professionals and substantiates the rehabilitation of younger breast cancer patients who suffer a great deal of physical, social and psychological turmoil after they are being diagnosed with breast cancer. A systematic review of the intervention of community health workers (CHWs) was carried out by Viswanathan et al., (2009). Their findings characterize that CHWs communicated with the partakers in varied array of settings. Of 53 studies, they categorized 27 as high intensity studies on the basis of interaction made. Further, the study substantiates that intervention and interaction of CHW enhanced knowledge of the participants. This is in contrast to other substitutes such as absence of interaction, mails or through media or through pamphlets. The study highlight the improvement in partakers health outcomes as well as in behavior. However, CHWs intervention in other diseases had greater impact on participants as compared to breast cancer edification, indicating the need of appropriate training to enhance the outcome of breast cancer awareness and referrals to allied health professionals. A paucity of translation of research into practice persists to address the discernment of the underlying reasons of delayed diagnosis of breast cancer in women and the methodological inadequacies. Randomized controlled trials of a training method to modify the process of breast cancer referrals in the allied health professional (AHP) are desired to distinguish and confer the problems related to the breast cancer in women in Ohio. Numerous studies have suggested that women require additional information regarding atypical symptoms of breast cancer and they must be encouraged to look for medical guidance as soon as a symptom is confusing (Heisey et al., 2011). Awareness in women may promote further enhanced responsiveness not only for self but also for their social sphere, implying the benefits of early detection and enhancement in breast cancer treatments (Mohamed et al, 2005). This proposed study may serve as an aid to breast cancer research organizations' promotion efforts. The training interventions evaluated here may be included in nurse aide curricula as breast health intervention plays a vital role in enhancing breast health awareness (Banning, 2011; Viswanthan et al., 2009). The role of family physician and AHP is imperative in encouraging women to present the symptoms of breast cancer at primitive stage. Improving awareness in women about the breast cancer is the prerequisite of the proposed study. Supportive therapeutics followed by regular health examinations including clinical examination of breast and screening through mammography as well as edification about non-lump symptoms of breast cancer is essential. An understanding is required to know that repercussions of delay so as to enhance the likelihood of earlier presentation of breast cancer symptoms. Literature reveals the paucity of appropriate training and interaction of CHWs with the women to generate breast cancer awareness followed by referrals to AHPs. The proposed study is based on a randomized controlled trial of training methods to modify the process of breast cancer referrals in the allied health professional (AHP) in Ohio. Background Selected articles relating to randomized controlled trial of a method to improve the process of breast cancer referrals in the Allied Health Professional (AHP) Field are described here: 1. Bauer, K. R., Brown, M., Cress, R. D, Parise, C. A., Caggiano, V. (2007). Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR) - negative, and HER2-negative invasive breast cancer, the so-called tri­ple-negative phenotype: a population-based study from the California cancer Registry. Cancer, 109(9), 1721-1728. Addressed that elements related to the socioeconomic condition plays a vital role in biological performance of breast cancer. 2. Gullatte, M. M., Brawley, O., Kinney, A., Powe, B., Mooney, K. (2010). Religiosity, spirituality, and cancer fatalism beliefs on delay in breast cancer diagnosis in African American women. J Relig Health, 49(1), 62-72. Addressed that delay in medical attention is attributed to lack of education, or those who believe in disclosing to God. 3. Kandivar, M., Joolaee, S., Joulaee, A., Bahrani, N., Hosseini, N. (2012). Breast cancer knowledge, attitudes and screening behaviors in two groups of Iranian women: physicians and non-health care personnel. J Cancer Edu, 27(4), 770-3. Addressed the need to generate increase awareness in women to implement screening and decrease the rate of breast cancer mortality. 4. Lebel, S., Tomei, C., Feldstain, A., Beattie, S.,  McCallum, M. (2013). Does fear of cancer recurrence predict cancer survivors' health care use? Support Care Cancer.  Mar; 21(3):901-6. doi: 10.1007/s00520-012-1685-3. Epub 2012 Dec 27. Addressed that patients with fear of cancer recurrence need to be monitored closely by their physicians as they need more healthcare services. 5. Smith, G. L., Shih, Y. C., Xu, Y., et al. (2010). Racial disparities in the use of radio­therapy after breast-conserving surgery: a national Medicare study. Cancer, 116(3), 734-741. Addressed that inequality is reported in receiving on time and high-quality treatment between African American women and White women 6. van den Biggelaar, F.J., Kessels, A.G., van Engelshoven, J. M., Flobbe, K. (2009). Costs and effects of using specialized breast technologists in prereading mammograms in a clinical patient population. Int J Technol Assess Health Care. Oct ;25(4):505-13. doi: 10.1017/S0266462309990377. Addressed the importance of reducing the work load of radiologists by utilizing the services of technologists hence reducing diagnostic costs. 7. van Ravesteyn, N. T., Schechter, C. B., Near, A. M., et al. (2011). Race-specific impact of natural history, mammography screening, and adjuvant treatment on breast cancer mortality rates in the United States. Cancer Epidemiol Biomarkers Prev, 20(1), 112-122. Addressed that in 1980s the prevalence rate of mortality due to breast cancer was same for Whites and African Americans in contrast to the recent reports (2005- 2009) which display that African American women display 41 percent more mortality rate than White women, even though the incidence rate is higher in White women. Research Questions Early detection of breast cancer saves lives and detection is facilitated through screening and tests. Whether this is true for African-American women in Ohio is yet to be identified. The questions to be addressed in this study are: RQ 1)  Does the type of training of AHPs contribute in increasing the knowledge of appropriate referrals for breast cancer screening? RQ2) What is the influence of race and gender of the AHPs on appropriateness of referrals for breast cancer screenings? Hypothesis 1: There will be no difference in the effectiveness of the two training methods for imparting knowledge to AHP on appropriate recommendations for breast cancer screening.  Hypothesis 2: Race nor gender will influence the effectiveness of the two training methods for imparting knowledge to AHP on appropriate referrals for breast cancer screening. Socio-culturally as well as widespread investigations are crucial to guide challenges as well as scientific investigations for reducing the mortality incidence due to breast cancer in AAW. Nature of the Study Randomized controlled trials of a training method will be followed to provide evidence for possible improvement to the process of breast cancer referrals in the allied health professional (AHP). Due to the traditional norms associated with gender and race, the alternative hypothesis is that the training modalities will increase the effectiveness of appropriate breast cancer referrals. This may result in better training of AHPs for breast cancer and other referrals that currently have race and gender barriers to needed medical and social services. The proposed study will distinguish and confer the problems related to the breast cancer in women belonging to Ohio region. Research Design Lay health workers (LHWs) and community health workers (CHWs) have shown promising advantages in endorsing programs like breast feeding, immunization and other infant and child related illnesses to reduce the mortality rate. Substantial results are also procured in enhancing treatment of tuberculosis (Lewin et al., 2005). However, there is diminutive support concerning the helpfulness of LHWs and CHWs in generating referrals for allied health professionals (AHPs). Limited studies are available to emphasize on the need of training LHWs and CHWs to generate awareness about breast cancer and to prevent the delay in seeking medical attention. The control group for the study involves non trained nurse aides. Experimental condition A versus B will improve the KSA (Knowledge skills awareness) among AHPs. Treatment A – a demonstration (a skit or role playing among the AHPs) to the randomized class. Treatment B – a step by step algorithm (or flow chart or steps) presented as part of a lecture and handout. Population and Sampling Plan There is no study that has addressed the need of increased breast cancer awareness and the process of breast cancer referrals among nurse aides in Ohio. Approximately 20,000 nurse aides are tested each year with about 29,800 on Ohio Nurse Aide Registry, and approximately, 8,900 of those are active in the field (Ohio Department of Health, 2010). As part of the skit or algorithm, clinical vignettes of typical patients that vary by race and gender will be presented for the AHP students to role play as either AHP or client (Treatment A) or to read as AHP about the present virtual client, then use the algorithm to refer or not (Treatment B). The clinical vignettes will be the same 10 client types across treatments and have 5 that need referrals and 5 that do not. A quasi-experimental design will be adopted for the proposed study where pre-and post-testing of each group will be carried out. Individuals of the control group are going to be the next training group. Data Collection Procedures Independent variable to be tested include psychological predisposition and help-seeking temperament, demographic factors as well as knowledge about cancer. Dependent variables to be considered patient delay including recognition of symptoms and delay in the treatment considered as system delay. Data Analysis Data will be analyzed using a student t test of correctly referred clients after the training and a pair t test of before and after training. A multivariate analysis will be conducted using regression to determine the effects of race and gender of the AHP using an interaction term for the training modality type. Conclusion Nurse aides are regularly in contact with people especially those requiring care; many of whom may have little or no knowledge about breast cancer prevention. By enhancing the understanding of the nurse aides about breast cancer, through training and education, awareness could be generated among Ohioans. The proposed study is imperative in establishing communication with the AHPs and for the improvement of referrals process, thereby aiding in earlier and timely breast cancer diagnosis. References American Cancer Society, Surveillance Research. (2011). Retrieved from http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf. Breast Cancer Facts & Figures 2011-2012, American Cancer Society, Surveillance Research (2011). Retrieved from http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-030975.pdf. Banning, M. (2011). Black women and breast health: a review of the literature. Eur J Oncol Nurs, 15(1), 16-22. Chatterjee, N., He, Y., & Keating, N. (2013). Racial differences in breast cancer stage at diagnosis in the mammography era. American Journal of Public Health, 103(1), 170-176. DiSipio,T., Hayes, S., Newman, B., Janda, M. (2009). What determines the health related quality of life among regional and rural breast cancer survivors? Aust N Z J Public Health, 33(6), 534-9. Easley, J., Miedema, B. (2012). Rehabilitation after breast cancer: recommendations from young survivors. Rehabil Nurs, 37(4), 163-70. Gass, J., Bell, J., Dizon, D. S. (2011). Breast care in 2011 and beyond: state policy of science. Expert Rev Anticancer Ther, 11(6):837-9. Gullate, M. (2006). The influence of spirituality and religiosity on breast cancer screening delay in African American women: application of the Theory of Reasoned Action and Planned Behavior (TRA/TRB). ABNF J, 17(2), 89-94. Gullatte, M. M., Brawley, O., Kinney, A., Powe, B., Mooney, K. (2010). Religiosity, spirituality, and cancer fatalism beliefs on delay in breast cancer diagnosis in African American women. J Relig Health, 49(1), 62-72. Kimlin, A.G. (1999). Health Behavior Change Models and Their Socio-Cultural Relevance for Breast Cancer Screening in African American Women. Women & Health, 28(4), 53-71. Heisey, R., Clemons, M., Granek, L., Fergus, K., et al. (2011). Health care strategies to promote earlier presentation of symptomatic breast cancer: perspectives of women and family physicians. Current Oncology, 18(5), e227-e237. Kandivar, M., Joolaee, S., Joulaee, A., Bahrani, N., Hosseini, N. (2012). Breast cancer knowledge, attitudes and screening behaviors in two groups of Iranian women: physicians and non-health care personnel. J Cancer Edu, 27(4), 770-3. Lewin, S.A., Dick, J., Pond, P., Zwarenstein, M., Aja, G., van Wyk, B., Bosch-Capblanch, X., Patrick, M. (2005). Lay health workers in primary and community health care. Cochrane Database Syst Rev, 25(1), CD004015. Mohamed, I.E., Skeel, W.K., Tamburrino, M., Wryobeck, J., Carter, S. (2005). Understanding locally advanced breast cancer: what influences a woman’s decision to delay treatment? Prev Med, 41, 399-405. Ohio Department of Health (2010). Nurse Aide Training Competency (NATCEP). Retrieved from http://www.odh.ohio.gov/odhPrograms/dc/natrg/na1.aspx. Thompson, H. S., Edwards, T., Erwin, D. O., Lee, S. H., et al. (2009). 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