Validation of an educational manual for breast cancer patients undergoing radiotherapy*

Objective: to validate the content and appearance of an educational manual for breast cancer patients undergoing radiation therapy. Method: methodological research, which had the Theory of Psychometry as a theoretical-methodological reference. The minimum 80% Concordance Index was considered to ensure the adequacy of the material. The sample consisted of 17 experts in the subject area of the educational manual and 12 patients previously submitted to radiotherapy due to the diagnosis of breast cancer. Results: two items of the expert evaluation tool were found to have a concordance index <80%. The other items were considered adequate and/or totally adequate in the three blocks of analysis proposed for the experts: objectives - 89.07%, structure and presentation - 92.94%, and relevance - 93.13%; and good and/or very good in the five blocks of analysis proposed for the patients: objectives, organization, writing style, appearance, and motivation, all with 100% agreement rate. Conclusion: the educational manual, after having been perfected based on the suggestions of the sample and the scientific literature, was considered valid according to its content and appearance, suggesting its contribution to the clinical practice of nursing and to the understanding of the treatment to which patients with breast cancer are submitted.

knowledge about the ways to prevent or minimize such effects is essential.

Besides the physical and systemic factors related
to the disease and treatment, it is worth mentioning the important psychological impact caused by the disease, mainly on the aesthetics of the body image, sexuality and femininity of women with breast cancer (3) . Therefore, it is essential that the nurse performs his or her assistance role related to the disease and therapy, as well as acting as a facilitator in the coping process by providing integral and individualized care (4) . Therefore, it is necessary to develop health technologies aimed at breast cancer patients undergoing radiotherapy, with the objective of transmitting knowledge and teaching regarding the guidelines and behaviors necessary for the management of the adverse effects of therapy.
Informational manuals are important strategies to support educational activities, as they facilitate the work of the health team by standardizing and improving patient understanding (5) . In view of this reality, the conduct of the nurse can be systematized through the use of a guidance manual, which should be effective in promoting information regarding treatment and self-care at home, as well as being important for controlling the adverse effects of radiotherapy (4) . The printed material can help the patient memorize information, which favors the work of the nurse in health education activities (6) .
Submitting an instrument or tool to the validation process before its use is essential in order to verify the real quality of the data and information transmitted (7) .
Therefore, before making a professional tool available for use, it is essential to evaluate it in order to know its effectiveness (8)(9) .
Taking into consideration the importance of ensuring the validity of the material before its use, the objective of this study was to validate the content and appearance of an educational manual intended for breast cancer patients undergoing radiotherapy.

Method
This is a methodological research, focusing on the development, evaluation and improvement of a methodological strategy: an educational manual for breast cancer patients submitted to radiotherapy. The preparation of the material began with a review of the literature on breast cancer, radiotherapy, its adverse effects and the care needed to prevent them, in addition to other relevant topics on the subject. The guidelines of an educational manual for head and neck cancer patients undergoing radiotherapy were considered as a model (4,10) , with the appropriate modifications and adaptations related to the subject matter addressed in this study. post-textual items (latest information, weekly diary and bibliographical references).
In general, the material includes information related to breast radiotherapy, such as equipment used and steps to be taken, and the adverse effects involved, such as radiodermatitis. In addition to this information, there are also guidelines related to skin care, such as the use of products, creams, perfume and deodorant in the region exposed to radiation, as well as their sanitation, and care related to hydration and food. Finally, the educational manual has a weekly diary, in which users can record the signs and symptoms perceived throughout the week, as well as the care given.
The content validation indicates to what extent a tool is adequate in relation to the approach of the information and knowledge involved, with the aim of testing the content and checking its adequacy according to the subject of interest. Therefore, at least six experts in the subject area of the material must be able to evaluate it individually, granting it validity.
The appearance validation, on the other hand, aims to verify that the manual is understandable to the target population, if it is clear, easy to read and understand, Cruz FOAM, Faria ET, Reis PED.
being based on the judgment of those who will use the instrument (11)(12)(13) .
The professionals involved were selected from contacts in the research group of which the researchers of this study are part, through analysis of the Curriculum Lattes of people who perform activities in the thematic field addressed in the educational manual. Intentional non-probabilistic sampling was used, since it excludes randomness in sample selection, which must be defined by means of requirements deemed necessary for its participation (14) . The factors used to choose these participants were then determined according to their degree, specialization, scientific production, knowledge and time of work on the topic involved (15) .
The invitation was sent by email to 28 professionals qualified to participate in the survey. One of the professionals expressed unwillingness to participate and ten did not respond to the invitation, even after three attempts to contact them and, therefore, were not included in the study. Once accepted, the materials corresponding to the evaluation were sent, also by e-mail, which were the Free and Informed Consent Term, the evaluation instrument and the educational manual to be evaluated. For appearance validation, the sample consisted of 12 patients previously submitted to radiotherapy due to the diagnosis of breast cancer. According to schooling, two participants studied until elementary school, seven studied until high school and three participants attended higher education. Age ranged from 32 to 53 years (M: 47 years; PD: 6). Regarding skin colour, seven declared themselves as brown, three as black and two as white. About marital status, ten were married, one divorced and one was single.
Only two participants were from Goiás, while the others were from the Federal District.
The evaluation instrument for the experts was composed of three blocks of analysis: objectives; structure and presentation; and relevance; while the instrument for patients previously submitted to Rev. Latino-Am. Enfermagem 2020;28:e3384. radiotherapy due to the diagnosis of breast cancer was composed of five blocks of analysis: objectives; organization; writing style; appearance; and motivation.
Regarding the validation process of content and appearance of the educational manual, the opinion of the experts and patients was analyzed in a quantitative way, through the answers given to the items in the evaluation instruments.    Table 4 presents the answers given by the patients and the CI of each item of the five blocks of analysis of the evaluation instrument intended for this sample.

Discussion
In relation to the first block of the evaluation instrument for experts (  improving the insomnia of patients (16) .
The objective of this research is, therefore, to provide a validated educational manual as a support strategy to be used as a guide to subsidize nursing care provided to patients with breast cancer undergoing radiotherapy.
In this way, the manual is part of an educational followup work done by the nurse, therefore, it should be a tool used concomitantly with the work process of this professional, and not in an isolated manner.
The different professionals who participated as profession (17) .
The item G, which analyses whether the educational manual meets the objectives of UNACON/HUB and other institutions working with radiotherapy, reached a CI of 70.58%, considering that two experts chose the option "not sure" and three chose the option "partially suitable" for that specific item. These experts have clarified their choice due to the particularities present in the services of different regions of the country. Even though it has been judged to be accessible to various socio-cultural layers, there are specificities arising from routine, planning techniques and care related to radiotherapy in each health institution, which may make the applicability of the educational manual in other services unfeasible, as observed in a previous study (4) . Therefore, the material should be adapted according to each service so that it can be used in other institutions that differ in treatment and/or population from UNACON/HUB.
It is essential to adopt clear language that is accessible to all layers of society, since the educational manual needs to be easy to understand. The information selected to be included in the material must be that which is really indispensable for it to be significant, attractive, concise and objective. It is also important to use images and photos correlated with textual information, as a way of illustrating the educational manual, stimulating its reading and facilitating its understanding, since they transform textual information into visual language (18)(19) .
Therefore, the educational manual needs to be planned and developed for the needs of the population, as a way to foster interest and understanding on the part of those who will benefit from the material. The language used must be clear, succinct and appropriate to the educational and cultural level of the population, and may be supported by illustrations and images, using the playful medium to promote communication, arouse interest and motivate the use of material (20) .
In relation to the changes made, the most about the increase in the superficial dose on the skin caused by a bolus effect of the deodorant, due to its aluminum composition (21)(22) .
In the scientific literature, there is evidence suggesting the use of deodorant by women who receive radiation for breast cancer, regardless of whether the product is composed of aluminum or not, in view of the Cruz FOAM, Faria ET, Reis PED.
concern of women who do not use deodorant in relation to the appearance of possible unpleasant odors (21)(22) .
However, there is no consensus and further studies are needed on the safety of using antiperspirants containing aluminum in their composition. Therefore, considering also the institutional routine already established at UNACON/HUB to avoid the use of this product during radiotherapy, such conduct was maintained in the educational manual.
The suggestion to include information on lymphedema has not been accepted, since such an effect is related to a chronic condition experienced after treatment, mainly due to axillary lymph nodes dissection associated with regional lymph node irradiation, and does not concern the adverse effects commonly encountered during radiotherapy (23) . The suggestion to add information on late treatment reactions, such as fibrosis and adherence, was also not accepted, since the proposed material is intended to accompany the patient during radiotherapy and guide her through the acute reactions of treatment.
The inclusion of too much information that is not essential for the moment experienced by patients can generate unnecessary anxiety and fear. Aspects related to the strategy of presenting the guidelines of a teaching material are very important, since the message conveyed must have credibility and confidence, and be appropriate to the context of the target audience, using only the information considered essential for a correct understanding of the text (10) . Therefore, the ideal is to highlight the indispensable and useful information for the self-care of the patient during the treatment.  (4) .
Therefore, the experts' responses were broadly in agreement. All three analysis blocks obtained a concordance index (CI) above the 80% established.
Regarding the responses of patients previously submitted to radiotherapy due to the diagnosis of breast cancer, the following were also concordant. All It is important to note that the content of the educational manual must be constantly updated based on scientific innovations and changes that may arise in the demands presented by breast cancer patients undergoing radiotherapy.
The limitation of this study is related to the fact that the apparent validation was performed by 12 women with breast cancer previously undergone radiotherapy, an apparently small number. However, this limitation can be justified by the fact that women from different levels of education were included, with participants who studied up to primary school, others who studied up to high school, and also participants who studied in higher education.

Conclusion
The educational manual was prepared from a objectives, organization, writing style, appearance, and motivation, all with a 100% Concordance Index.
It is suggested that the educational manual may contribute to the clinical practice of nursing and to the understanding of the therapy to which breast cancer patients are subjected when undergoing radiotherapy.