Gated DIBH for Left Sided Breast Cancer Patients

Gated DIBH for Left Sided Breast Cancer PatientsChapter III mannerological analysis3.1 inquiry ObjectivesThe explore project examines left-sided dope messcer long-sufferings receiving therapy with gated DIBH technique use the commercially avail able revolutions per minute system. The primary objective of this interrogation is to esteem whether left-sided breast cancer longanimouss go away benefit from gated DIBH. The interest in per found this investigate arises from having m all left-sided breast cancer long-sufferings that have large flashiness of vegetable marrow in the discourse field, and hence argon at find for cardiac toxicities in the future. The secondary objectives of this investigate is to look at forbearing roles quilt and downstairsstanding, and ray of light therapists workload. This chapter impart dissertate the savour selection, estimable issues, instrumentation, entropy collection unconscious processs, selective information analysis, l imitations, evaluate results, work discover and clippingline.3.2 Sample selection and descriptionThe judge sample sizing was calculate victimization the legislation (Chan, 2003) for paired samples as seen below,Total sample size = where c is 10.5 for 90% power, is the standardised effect size, given by the formula (Chan, 2003)where 1 and 2 be the meaning of the two give-and-take groups, and is the communal standard deviation.The 90% power represents the probability of rejecting the null hypothesis when it is out of true (Chan, 2003). It is postulated that a good interference loss () amid the 2 groups is 0.2 units with an SD () of 0.5 units (Chan, 2003). With these set, the pass judgment sample size is 68.Sixty-eight left-sided breast cancer patients result be selected for this research victimisation a simple random sampling method acting. The patient population will be chosen at random to execute a diverse group of patients with variable breast and centre volum es.The criteria for this sample would be female patients with left-sided breast cancer below the age of 70. In addition, the patients must be able to hold their breath. These patients will be recruited afterward being screened by the oncologists. The oncologists will do a simple breath-hold interrogatory with patients to adjudicate if they are able to hold their breath for at least(prenominal) 20 seconds. This is because patients will be filmd to hold their breath during the CT gaze for a sequence of 18 seconds.This research will require 2 sets of computed-tomography (CT) scans from each patient of which one is at free active and the other at DIBH. Both sets will have identical patient setup. Patients will be lying supine with some(prenominal) arms to a higher place head on a posirest, having the visual goggles on (see vermiform accompaniment M, image A) with a 6-reflective markers block on patients introductory abdominal surface (see extension H). With the goggles, th ey are able to view the screen, as seen in image B in Appendix M, in revisal to see their breathing patterns. For each patient, 2 treatment plans will be generated one using the CT images at free breathing with photon negatron see technique and the other using the CT images at DIBH with gated DIBH technique using rev with 3-mm intervals.3.3 ethical Issues and Informed consentAny research involving human subjects conducted in the hospital would require adherence to ethical standards. The procedure requires the collation of a list of investigators in the department that intends to conduct clinical trials (see Appendix N), and to apply and attend the Singapore Guideline for Good clinical Practice (SGGCP) course. This Course projects that the conduct of clinical trials follows internationally acceptable ethical and scientific standards (see Appendix O). The ethics polish up will be carried out by the National healthcare Group domain specific review board which is an independent c ommittee constituted of medical, scientific and non-scientific members, whose responsibility is to ensure the protection of the rights, guard duty and well-being of human subjects involved in a research study by reviewing, approving and providing continuing review of research studies, and of the methods and materials to be utilise in obtaining and documenting informed consent of the research subjects (National University wellness System, 2010). When a principal investigator submits an application via the research online administration and focussing system, it is automatically routed to the department part for endorsement, and subsequently the institution representative for endorsement, forward it is delivered to the domain specific review board secretariat (National University Health System, 2010). completely research studies submitted will be classified under one of the avocation review categories exempt review, expedited review, full Board review (see Appendix P) (National University Health System, 2010). Based on the definitions in Appendix P, this study is classified as an expedited review.Ethics approval for research is needed for several reasons. Firstly, ethical norms sanction the aims of research, much(prenominal) as knowledge, truth, and avoidance of error (Resnik, 2011).Secondly, ethical standards promote the values that are essential to collaborative work, such as trust, accountability, mutual respect, and pallidity (Resnik, 2011). For example, guidelines for authorship, copyright and patenting policies, data sharing policies, and confidentiality rules in peer review, are intentional to protect intellectual property interests while encouraging collaboration (Poortmans, 2013).honorable norms in research also help to build public substitute for research as people are more likely to farm animal research project if they can trust the quality and integrity of research (Resnik, 2011).Finally, m both of the norms of research promote a variety of other central moral and social values, such as social responsibility, human rights, form with the law, and health and safety. This also protect the rights and welfare of participants and minimise the risk of personal and mental discomfort and harm from research procedures (Canterbury Christ Church University, 2006). Ethical lapses in research can significantly harm human subjects curiously if the researcher fails to abide by the regulations and guidelines relating to shaft of light therapy or biological safety (Resnik, 2011).Informed consent is the process by which the patient voluntarily confirms her willingness to get into in this research, after being informed of all the aspects of the research that are relevant to her decision-making (National Healthcare Group, 2013). The informed consent is documented by means of written signatures, date informed consent form and the language use during the explanation to the patient by the oncologist. In the consent, in that locati on should be 3 signatures the patients, the doctors and the witness signature. For patients who cannot read and announce English, a qualified translator will be around during the signing of the consent.3.4 Research design and instrumentationThis research is a mixture of qualitative and vicenary research methods (see Appendix Q). Quantitative research corresponds to a deductive scientific method of research which uses data in the form of numbers and statistics to trial run hypotheses, using a large and randomly selected sample that is a representative of the population (Pearce, et al. 2013 Johnson Christensen 2010).This is in contrast to the qualitative approach which corresponds to an inductive method of research which uses words, pictures or objects to examine a phenomenon, requiring unless a lower-ranking and non-randomly selected sample (Pearce, et al. 2013 Johnson Christensen 2010).Patients will be scanned using Toshiba Aquilion Large Bore CT-simulator (Toshiba, 2014). Th e treatment plans will be generated using Varian Medical Eclipse Treatment mean System and patients will be treated with DIBH technique using revolutions per minute from Varian Trilogy unidimensional gunman (Varian Medical System, 1999-2014).3.5 Data collection proceduresThe very(prenominal) irradiation oncologist will perform all the delineation of the clinical target volume, the smell and LADCA for consistency purposes (see Appendix R). The delineation will be done consort to radiation therapy oncology group (RTOG) breast contouring recommendations (Goksel, et al., 2013). Patients CT images at breath hold will be used to plan for DIBH technique while the one at free breathing will be planned for photon negatron catch technique. The treatments will be planned such that the clinical target volumes coverage of the dose diffusion is kept betwixt 90% and 110% of the prescribed dose. For each plan, affectionateness and LADCA volumes were calculated in cm3. Dose volumes to th e heart and LADCA will be normalized by dividing with the total organ volume. Heart and LADCA volumes receiving 5Gy to 50Gy (V5-V50) will be generated for comparison of treatment techniques. Dose statistical distributions can be presented as DVHs and representing the statistical dose distribution in a volume of interest. These statistical data will be recorded and presented in tables.Patient education is a very consequential component in DIBH technique using revolutions per minute to reduce fear and increase their confidence about receiving radiation therapy (Halkett Kristjanson, 2007). Patient education tools can be in many forms such as video or pamphlet (Halkett Kristjanson, 2007). For this research, a pamphlet have been created to educate patients on DIBH technique using RPM (see Appendix S). A qualitative research method such as face-to-face converse is chosen to valuate patients comfort and understanding at the middle of the treatment and on the last twenty-four hour p eriod of treatment as this only require the patients to speak the same language in which the questions are asked, and to have basic oral and listening skills (Bowling, 2009). The primary objective of this standardised and open-ended oppugn (Valenzuela Shrivastava, n.d.) is to determine the degree of understanding as well as patients comfort. The questions (see Appendix T) will be asked by the oncologist during the middle of the treatment and on the last day of treatment.The advantages of face-to-face interviews are that reading and writing skills are not required, interviewers are able to probe fully for responses and clarify any ambiguities, they can ask more complicated and detailed questions, and patients are able to clarify if they do not understand the questions (Bowling, 2009). This would be a give away technique than self-administered questionnaires because pre-coded response choices may not be sufficiently countrywide and patients may be forced to choose inappropriate pre-coded answers that might not fully represent their views (Bowling, 2009). This causes the data to be bias as the patients replies are influenced by the design of the pre-coded response choices. Self-administered questionnaires also faux that the questions are worded in a way that is understood by the patients (Bowling, 2009). Patients may misinterpret the questions and reply based on their own interpretation and questionnaires may be a problem for patients who are unable to read or write (Bowling, 2009). Most importantly, one-to-one interviews with standardised questions appeared to have the highest reliability (University of Leicester, n.d.).The radiation therapists workload will be measuring stickd in terms of learning hours, and the comparison of treatment duration and manpower required for gated DIBH using RPM and photon electron match technique (see Appendix U) will be recorded and presented in charts.3.6 Data analysisPaired samples t-test will be used to determine whet her thither is a significant dissimilitude between the average dose to the heart and LADCA values made under photon electron match plan and gated DIBH using RPM plan (Norman Streiner, 2008). This is used because the data are careful at the scale level and the data are related (Hawkins, 2009). The amount of radiation received by the heart can be recorded by comparing the DVHs of the photon electron match with gated DIBH using RPM. The statistical figures can be analysed using Statistical bundle for Social Sciences (SPSS) (Yavas, et al., 2012). Paired samples t-test will be used to determine whether there is a significant difference between the average dose to the heart and LADCA values made under photon electron match plan and gated DIBH using RPM plan (Easton McColl, 2014). A p-value of Patients understanding and comfortThe questions (see Appendix T) from the standardised and open-ended interview were developed by a team of 2 radiation oncologists, a nurse and 2 radiation thera pists. The areas of discussion were based on the groups clinical view with left-sided breast cancer patients and their extensive knowledge on DIBH using RPM. The interview aims to determine the patients level of comfort and understanding of the gated DIBH using RPM. The design of the questionnaire will determine the reliability and validity of the opened-ended interview to measure patients level of comfort and understanding.Reliability is defined as the extent to which questionnaire will produce the same results on repeated trials (Miller, n.d.), and is measured by its equivalence and stability. Equivalence reliability surveyes the consistency of the judgement of the patients answer by the interview (Miller, n.d.). It is improved by pre-empting a range of responses that might be given by the patients and give a pre-determined rating to each response so that the interviewers will have the same level of judgement (Miller, n.d.). For example, _____________-Stability reliability is co rrelated to the repeatability of the patients response under the same conditions after a period of time (Miller, n.d.). For this interview, the patients will be interviewed twice, once during mid-treatment and the other on the last day of their treatment. Their responses from both sessions will be compared to determine if there are any deviance. This assumes that the characteristics that is measured doesnt change with time, and that the time period is long lavish that the memories from the 1st interview will not influence the responses of the 2nd interview (Miller, n.d.).The validity of the interview is the extent to which the interview questions measures what it purport to measure, and it generally takes the form of content validity (Miller, n.d.). Content validity is the degree to which the questions fully assess or measure the intention of the interview (Miller, n.d.). This was determined by permit the team review the individual questions for readability, clarity and comprehens iveness and come to some(a) level of agreement as to which items should be included in the concluding interview questions. The interview questions (see Appendix T) were reviewed and accepted by the team prior to the conduct of the interview.The treatment duration will be recorded as seen in Appendix U and a paired samples t-test similar to appendix V will be used to determine whether there is a significant difference, where the null hypothesis (H0) is there is no difference between the treatment time with photon electron match technique and DIBH using RPM technique.The radiation therapist workload will be analysed based on the minimum number of manpower required for gated DIBH using RPM as compared to photon electron match technique and in terms of training hours. This will be discussed among the radiation therapists and presented in charts.3.7 LimitationThis research can only sample from a small size due to constraint of resources where there is only 1 treatment unit that has the RPM equipment required for DIBH technique. The evaluate sample size calculated is only an estimate as the treatment difference and standard deviation are never known in advance (Norman Streiner, 2008). As such, the actual sample size may be slightly smaller than 68.3.8 judge ResultsThe results from this research are expected to depute optimal radiation exposure volumes and doses for the heart and LADCA when treated with gated DIBH using RPM compared to photon electron match technique at free breathing. These results are expected to be compatible with findings from previous studies (Pedersen, et al., 2004 Korreman, et al., 2005 Shim, et al., 2012 Mast, et al., 2013). As such, showing that patients with left sided breast cancer will benefit from gated DIBH using RPM. Treatment time duration for gated DIBH using RPM is expected to have a significant difference and be faster than photon electron match technique. As gated DIBH using RPM is new to the radiation therapists, the worklo ad is expected to be heavier in the beginning.3.9 work outThere will be no additional cost for this research as the RPM equipment is already available together with the linear accelerator from Varian (Varian Medical System, 1999-2014). There will be no cost for training on the usage for RPM by Varian as it was included in the package when the linear accelerators were bought in 2013. Patients recruited for this research will be aerated the same cost as photon electron match treatment technique.3.10 Expected TimelineThis research aims to commence from January 2015 till December 2015. The work plan for both the principal investigator and research assistants can be seen in Appendix W.Chapter IV ConclusionThis research aims to review gated DIBH using RPM as a treatment technique for left-sided breast cancer patients as compared to photon electron match in terms of the radiation dose received by the heart and LADCA. Paired t-test is chosen to measure the significant difference between th e dose received by the heart in photon electron match technique and DIBH using RPM technique. Based on literatures that were review, the results are expected to be in favour of gated DIBH using RPM. Interviews will be conducted to assess patients comfort and understanding about gated DIBH using RPM. And data collection will be done calculate the workload of the radiation therapist. The results from interview and data collection will allow us to gauge further if it is really practical to implement gated DIBH using RPM in our department. If the results are clinically significant and positive, gated DIBH using RPM will be implemented into our department.4.1 RecommendationFor future recommendation to try contrast-enhanced CT scan in left-sided breast patients so that the LADCA can be seen clearly in the scan and able to be delineated by the doctor in effect (Yu, et al., 2013). This is to increase the accuracy of the delineation of LADCA as well as the accurate amount of radiation dose received by it. After this research, other study can be done in the future on the reproducibility of patients breath holding level for each fraction using a cine acquisition mode (CAM) of a linear accelerator during treatment (Goksel, et al., 2013).