Protocols for telephone follow-up of people with gastrointestinal cancer undergoing chemotherapy

Abstract

Objective

To describe the process of construction and validation of protocol content and appearance for telephone follow-up to reduce side effects (lack of appetite, nausea and vomiting, diarrhea and constipation) associated with outpatient antineoplastic chemotherapy for people with gastrointestinal malignancy.

Methods

This is a methodological and quantitative study, carried out from September to November 2020, in three stages: scoping review development, protocol construction and material assessment by experts. They were developed according to the Pasquali’s psychometrics methodological framework. For content assessment, the Delphi technique was used in two rounds (Delphi I [16 judges] and Delphi II [12 judges]) and, those items with Content Validation Coefficient (CVC) were considered valid greater than 0.80 and consensus of more than 80.0% in the Delphi technique. Data were analyzed using descriptive and inferential statistics (Binominal test).

Results

All protocol requirements reached agreement among the judges above 80.0% as well as all items reached statistically significant levels of assessment. At the end of Delphi II, the four protocols were significantly valid (lack of appetite [CVC = 0.98]; nausea and vomiting [CVC = 0.99]; diarrhea [CVC = 0.99]; and constipation [CVC = 0.98]).

Conclusion

The content of the protocols demonstrated high credibility and their adoption in health institutions can contribute to telephone follow-up in reducing side effects (lack of appetite, nausea and vomiting, diarrhea and constipation) associated with outpatient antineoplastic chemotherapy for people with gastrointestinal malignancies.

Telenursing; Oncology nursing; Gastrointestinal neoplasms; Drug therapy, Combination; Ambulatory care

Resumo

Objetivo

descrever o processo de construção e validação de conteúdo e aparência de protocolos para o acompanhamento por telefone na redução dos efeitos colaterais (inapetência, náusea e vômito, diarreia e constipação) associados à quimioterapia antineoplásica ambulatorial para pessoas com neoplasia maligna gastrointestinal.

Métodos

Estudo metodológico e quantitativo, realizado no período de setembro a novembro de 2020, em três etapas: realização de scoping review, construção dos protocolos e avaliação do material por especialistas. Foram desenvolvidos segundo o referencial metodológico da psicometria de Pasquali. Para avaliação de conteúdo, empregou-se a técnica de Delphi em duas rodadas (Delphi I [16 juízes] e Delphi II [12 juízes]) e, considerou-se válidos aqueles itens com Coeficiente de Validação de Conteúdo (CVC) maior que 0,80 e consenso de mais de 80,0% na técnica de Delphi. Os dados foram analisados por meio da estatística descritiva e inferencial (Teste binominal).

Resultados

Todos os requisitos dos protocolos alcançaram concordância entre os juízes superior a 80,0%, bem como todos os itens atingiram níveis de avaliação estatisticamente significativos. Ao final do Delphi II, os quatro protocolos se apresentaram expressivamente válidos (inapetência [CVC = 0,98]; náusea e vômito [CVC = 0,99]; diarreia [CVC = 0,99]; e, constipação [CVC = 0,98]).

Conclusão

O conteúdo dos protocolos demonstrou alta credibilidade e, sua adoção nas instituições de saúde, pode contribuir para o acompanhamento por telefone na redução dos efeitos colaterais (inapetência, náusea e vômito, diarreia e constipação) associados à quimioterapia antineoplásica ambulatorial para pessoas com neoplasia maligna gastrointestinal.

Telenfermagem; Enfermagem oncológica; Neoplasias gastrointestinais; Quimioterapia combinada; Assistência ambulatorial

Resumen

Objetivo

Describir el proceso de construcción y validación de contenido y apariencia de protocolos para el acompañamiento por teléfono en la reducción de los efectos colaterales (inapetencia, náuseas y vómitos, diarrea y constipación) asociados a la quimioterapia antineoplásica ambulatoria para personas con neoplasia maligna gastrointestinal.

Métodos

Estudio metodológico y cuantitativo, realizado en el período de septiembre a noviembre de 2020, en tres etapas: realización de scoping review , construcción de los protocolos y evaluación del material por especialistas. Fueron desarrollados según el referente metodológico de la psicometría de Pasquali. Para la evaluación de contenido se utilizó la técnica de Delphi en dos rondas (Delphi I [16 jueces] y Delphi II [12 jueces]) y se consideraron válidos los ítems con Coeficiente de Validez de Contenido (CVC) superior a 0,80 y consenso superior al 80,0 % en la técnica de Delphi. Se analizaron los datos por medio da estadística descriptiva e inferencial (Prueba binominal).

Resultados

Todos los requisitos de los protocolos alcanzaron la coincidencia entre los jueces superior al 80,0 %, así como todos los ítems alcanzaron niveles de evaluación estadísticamente significantes. Al fin del Delphi II, los cuatro protocolos se mostraron expresivamente válidos (inapetencia [CVC = 0,98]; náuseas y vómitos [CVC = 0,99]; diarrea [CVC = 0,99]; y constipación [CVC = 0,98]).

Conclusión

El contenido de los protocolos demostró alta credibilidad y su adopción en las instituciones de salud, puede contribuir para el acompañamiento por teléfono en la reducción de los efectos colaterales (inapetencia, náuseas y vómitos, diarrea y constipación) asociados a la quimioterapia antineoplásica ambulatoria para personas con neoplasia maligna gastrointestinal.

Teleenfermería; Enfermería oncológica; Neoplasias gastrointestinales; Quimioterapia combinada; Atención ambulatoria

Introduction

In the oncological context, there has been an increase in the use of outpatient treatments, which represent a different context from hospitalization. Compared to the hospital setting, outpatient antineoplastic chemotherapy (AC) results in better quality of life (QoL) and lower treatment costs for patients. However, administering outpatient AC is challenging due to high demand, time pressures, and low level of control. Also, side effects tend to occur at home.( ¹ , ² )

AC is a type of systemic treatment, consisting in the use of drugs that, alone or in association, act in the process of cell growth and division and,( ¹ )systemic toxicities are prevalent and often little recognized, resulting in high rates of uncomfortable symptoms and, consequently, avoidable emergency room visits and hospitalizations.( ¹ , ³ - ⁶ )

Outpatient care requires patients to manage symptoms in their home, however, on a regular basis, these people are inadequately prepared or forget instructions on how to deal with unrelieved symptoms.( ⁷ )As a result, the management of symptoms of malignant neoplasm is often unsatisfactory.( ⁸ , ⁹ )

Nursing care in oncology, based on good practices, requires the construction and implementation of an interconnected system of care protocols, which allows the realization of nursing actions based on scientific evidence, contributing to professional decision-making effectively, quickly and individually.( ¹⁰ , ¹¹ )

It is noteworthy that telephone follow-up is a modality of care that allows interaction between health professionals and their patients.( ¹ )The telephone intervention in the daily routine of nursing has been recommended as a significant aid to clinical practice, as it can provide important contributions to health promotion, as it enables the control of adverse effects, fast driving and support for therapeutic adherence.( ¹² )In fact, telephone follow-up is an intervention established by the Nursing Interventions Classification (NIC), which allows monitoring a person’s health conditions to act in circumstances of an abnormal state.( ¹ , ¹³ )The relevance of this study is to provide protocols in order to substantially contribute to the provision of quality care.

This study aimed to describe the process of constructing and validating protocol content and appearance for telephone follow-up to reduce side effects (lack of appetite, nausea and vomiting, diarrhea, and constipation) associated with outpatient antineoplastic chemotherapy for people with gastrointestinal malignancies.

Methods

This is a methodological study, carried out from September to November 2020, based on the Pasquali’s psychometrics methodological framework,( ¹⁴ )developed in three stages: scoping review, construction of protocols and content validation and appearance by judges/experts.

Initially, the results from a scoping review were used according to the international guide PRISMA-ScR recommendations( ¹⁵ )and in the method proposed by the Joanna Briggs Institute, Reviewers Manual 2020,( ¹⁶ )based on national and international scientific evidence (^{Appendix 1}). The Common Terminology Criteria for Adverse Events (CTCAE) version 5,( ¹⁷ )produced by the North American National Cancer Institute (NCI), was also used; the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) and the Classification of Nursing Interventions (NIC) taxonomy.( ¹³ )

The scoping review protocol was registered in the Open Science Framework (https://doi.org/10.17605/OSF.IO/5S7DE). The participant, concept and context (PCC) strategy was used to construct the research question, in which: P (participants) - oncology nurse; C (concept) - telephone follow-up of patients with gastrointestinal malignancies; and C (context) – antineoplastic chemotherapy clinics. Thus, the established research question was: what scientific evidence, in the context of outpatient antineoplastic chemotherapy, is available for telephone follow-up of patients with gastrointestinal malignancies performed by nurses?

The search strategy was adapted according to each database’s specificities, and the analogous combination of descriptors was preserved: (“Telemedicine”[Mesh] OR “Telenursing”[Mesh] OR “Telephone”[Mesh] OR “Telephone Consultation” (Iowa NIC) OR “Telehealth”[Mesh]) AND (“Oncology Nursing”[Mesh] OR “Nursing”[Mesh]) AND (“Anus Neoplasms”[Mesh] OR “Cecal Neoplasms”[Mesh] OR “Colonic Neoplasms”[Mesh] OR “Digestive System Neoplasms”[Mesh] OR “Duodenal Neoplasms”[Mesh] OR “Gastrointestinal Neoplasms”[Mesh] OR “Ileal Neoplasms”[Mesh] OR “Intestinal Neoplasms”[Mesh] OR “Jejunal Neoplasms”[Mesh] OR “Sigmoid Neoplasms “[Mesh] OR “Stomach Neoplasms “[Mesh] OR “Esophageal Neoplasms “[Mesh] OR “Colorectal Neoplasms”[Mesh]).

After selecting the descriptors and synonyms, an electronic search of the studies was carried out, from November 2019 to January 2021, in the PUBMED (National Library of Medicine and National Institutes of Health), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Web of Science, Scopus, LILACS (Latin American and Caribbean Health Science Literature) and Cochrane Central Library databases.

Articles published in Portuguese, English or Spanish, with abstracts available in full in the selected databases, which addressed telephone follow-up by nurses with patients with gastrointestinal malignancies, from 2013 onwards were included. This time frame was justified due to the framework of the Brazilian National Policy for Cancer Prevention and Control in the Health Care Network for People with Chronic Diseases ( Política Nacional para a Prevenção e Controle do Câncer na Rede de Atenção à Saúde das Pessoas com Doenças Crônicas ) within the scope of the Unified Health System ( Sistema Único de Saúde ).( ¹⁸ )Studies that did not include the guiding question, editorials, experience reports, theoretical essays, a single case study and surveys that addressed telephone follow-up carried out by health professionals who were not nurses were excluded.

Studies were selected by two independent reviewers, with the goal of confirming their relevance to the scope review questions and, if so, the data of interest was extracted. Doubts or inconsistencies were resolved by consensus among the authors. For separating, summarizing and reporting the essential information found in each study, a structured instrument was used to collect these data, which allowed the synthesis, interpretation and analysis of the extent, nature and distribution of the studies incorporated in the review.( ³ )

In the process of elaborating the protocols, the construct was subdivided into four modalities (all containing a flowchart with a graphic algorithm followed by detailed guidelines with nursing interventions/actions, in addition to a scientific foundation), namely: a) Protocol for telephone follow-up to reduce the inappetence of people with gastrointestinal malignancies undergoing outpatient antineoplastic treatment (PNMGTAA); b) Protocol for telephone follow-up to reduce nausea and vomiting of PNMGTAA; c) Protocol for telephone follow-up to reduce PNMGTAA diarrhea; d) Protocol for telephone follow-up to reduce PNMGTAA constipation.

It is noteworthy that the algorithms were developed according to Pimenta et al.’s proposal,( ¹⁹ )in which there is the use of graphic forms with certain meanings in the construct. They present an initial approach to patients over the telephone, in order to check the connection quality; description of drugs with high and moderate degree to cause the respective side effects of each protocol; questions related to the frequency, characteristics, period and management of inappetence, nausea and vomiting, diarrhea and constipation; guidance in cases of complications and/or worsening of symptoms related to outpatient AC.

Each of these protocols was assessed according to the criteria established by Pasquali:( ¹⁴ )behavior, objectivity, simplicity, clarity, relevance, accuracy, variety, modality, typicality, credibility, breadth and balance. It should be noted that there was a framework elucidating each of these 12 criteria and they were assessed using a Likert-type scale as follows: “1 - inadequate (I)”, classified as disagreement degree; “2 - partially adequate (PA)”; “3 - adequate (A)”, labeled as degree of agreement.

In the protocol validation stage, in order to reach the number of judges recommended by Pasquali,( ¹⁴ ), i.e., six to 20 judges. This process was guided through the analysis of selected expertise for the research, through the appreciation of resumes in the CNPq’s Platforma Lattes . For this purpose, the simple search form was used, in the field “search for”, in the category “subject”, through the use of the terms “oncology” and/or “chemotherapy” and/or “validation”. A total of 389 doctors were identified.

For the screening of possible expertise, the Fehring model( ²⁰ )was adapted and used (maximum score of 14 points), with a minimum score of five points being assigned: master’s and doctorate in nursing or related fields (mandatory criterion); dissertation or thesis on oncology and/or validation (3 points); oncology experience of at least three years (3 points); certificate or title of expert in oncology nursing (2 points); research in oncology and/or validation in the last five years (2 points); authorship of at least two articles, in the last two years, in oncology (2 points); participation in a research group involving the theme Oncology and/or validation (2 points).( ²⁰ )

After the search, the first 50 eligible judges were chosen. These received an invitation letter by email, with a period of up to 20 days to respond; in addition to the Informed Consent Form (ICF), with instructions to be able to analyze and assess the protocols. The instrument to be completed for validation was built in Google Docs, with participant characterization information, graphic algorithms and guidelines. After each protocol there was a space in which judges could provide suggestions for modification and improvement.

This process was conducted using the Delphi technique. In Delphi I, 16 experts participated, a stage in which there were suggestions for changing the protocols to improve them. After analyzing the Delphi I data and reformulating the protocols, as recommended by experts, they were contacted and sent a new electronic form with protocols adjusted for a new assessment (Delphi II), 12 judges participated. To fill out the form, the judge needed approximately 40 minutes and, after starting the validation process, it could not be discontinued.

For protocol assessment, experts’ judgments were entered into a database in Microsoft Excel 2016®, and after being analyzed, the scores attributed to each protocol were verified. Protocol relevance was obtained by applying the CVC.( ²¹ )The item that presented more than 80% of agreement among judges (assessed as adequate) and a CVC>0.80.( ²² )

Nevertheless, a descriptive and inferential analysis (binomial test) was carried out. For this purpose, ρ-value≤0.05 was adopted as a parameter for statistical significance.

The research was approved by the Institutional Review Board of the Universidade Federal de São João del-Rei , under Opinion 2.010.532, and it is a subproject of an “umbrella” research entitled Collective construction of protocols and manuals.

It is noteworthy that the external validation of the protocols has not yet been carried out, since it is the elaboration of protocols that, only after their implementation, can be re-assessed and adjusted when necessary.

Results

For protocol construction, the changes made consisted of, essentially, in objectivity, simplicity, clarity, relevance, variety (language is adequate and allows content interactivity), modality (vocabulary is appropriate, without generating misunderstandings), and typicity (vocabulary is consistent with the theme, with adequate concepts). Each completed protocol had a flowchart with a graphic algorithm followed by detailed guidelines with nursing interventions (^{Appendix 2}).

It is noteworthy that, in these protocols, patients who undergo AC with the potential for nausea, vomiting, diarrhea and constipation will need to be assessed by a nurse, by applying the CTCAE scale. Persons in the first AC cycle must have a record of the guidelines provided in accordance with the protocols. From the second AC cycle, it will be necessary to have a medical record, the guidelines provided/modified and patient adherence or not, with the respective reasons as well as any person’s refusal to follow the guidelines.

In the validation process, the expert committee was composed of 16 professionals in the first round and 12 in the second (it is noteworthy that these 12 experts collaborated in both rounds), with the loss of four judges due to the non-return of the protocols within the term signed in advance. Doctors with care and management experience in oncology participated, in addition to teaching. Experts’ minimum age was 35 years and the maximum was 58 (mean=40.12 and standard deviation=6.75 in Delphi I; mean=42.71 and standard deviation=7.80 in Delphi II), whose mean training time was 20.20 and standard deviation=5.81 in Delphi I; mean=19.64 and standard deviation=5.84 in Delphi II. They worked in four regions of Brazil, namely: southeast with 13 (81.1%) judges, northeast, center-west and south, with one (6.3%) expertise each.

Table 1 describes the final consensus among judges regarding the analyzed items of protocol content for telephone follow-up in the reduction of side effects (lack of appetite, nausea and vomiting, diarrhea and constipation) associated with AC for people with gastrointestinal cancer, who obtained agreement (“adequate”), according to Pasquali’s assessment criteria.

Table 1
Consensus among judges in Delphi I and II stages for the items assessed of protocol content for telephone follow-up in the reduction of side effects (lack of appetite, nausea and vomiting, diarrhea and constipation) associated with outpatient chemotherapy for people with gastrointestinal cancer

Items	Reduction of side effects associated with chemotherapy
	Inappetence		Nausea and vomiting		Diarrhea		Constipation
	Delphi I (p-value*) n(%)	Delphi II (p-value*) n(%)	Delphi I (p-value*) n(%)	Delphi II (p-value*) n(%)	Delphi I (p-value*) n(%)	Delphi II (p-value*) n(%)	Delphi I (p-value*) n(%)	Delphi II (p-value) n(%)
Behavior	0.01(89.5)	0.00(100.0)	0.02(87.5)	0.00(100.0)	0.04(85.4)	0.00(100.0)	0.18(81.2)	0.00(100.0)
Objectivity	0.01(89.5)	0.00(100.0)	0.04(85.4)	0.00(100.0)	0.04(85.4)	0.00(100.0)	0.18(81.2)	0.00(100.0)
Simplicity	0.01(89.5)	0.00(100.0)	0.01(89.5)	0.00(100.0)	0.04(85.4)	0.00(100.0)	0.04(85.4)	0.00(100.0)
Clarity	0.01(89.5)	0.002(97.2)	0.02(87.5)	0.00(100.0)	0.07(83.3)	0.00(100.0)	0.30(79.1)	0.002(97.2)
Relevance/pertinence	0.01(89.5)	0.00(100.0)	0.01(89.5)	0.00(100.0)	0.04(85.4)	0.002(97.2)	0.04(85.4)	0.00(100.0)
Accuracy	0.04(85.4)	0.00(100.0)	0.02(87.5)	0.002(97.2)	0.02(87.5)	0.00(100.0)	0.30(79.1)	0.002(97.2)
Variety	0.01(89.5)	0.00(100.0)	0.01(89.5)	0.00(100.0)	0.02(87.5)	0.00(100.0)	0.02(87.5)	0.00(100.0)
Modality	0.01(89.5)	0.002(97.2)	0.01(89.5)	0.00(100.0)	0.003(91.6)	0.00(100.0)	0.07(83.3)	0.00(100.0)
Typicity	0.01(89.5)	0.00(100.0)	0.003(91.6)	0.00(100.0)	0.003(91.6)	0.00(100.0)	0.04(85.4)	0.00(100.0)
Credibility	0.01(89.5)	0.00(100.0)	0.01(89.5)	0.00(100.0)	0.02(87.5)	0.00(100.0)	0.02(87.5)	0.00(100.0)
Breadth	0.003(91.6)	0.00(100.0)	0.003(91.6)	0.00(100.0)	0.04(85.4)	0.00(100.0)	0.04(85.4)	0.00(100.0)
Balance	0.00(100.0)	0.00(100.0)	0.01(89.5)	0.00(100.0)	0.01(89.5)	0.00(100.0)	0.02(87.5)	0.00(100.0)

• *p-value referring to the Binominal test (significant for p-values<0.05)

According to what was exposed in Table 1 , it was observed that the care protocols inappetence, nausea and vomiting and diarrhea were within the recommended breadth to be considered valid from the Delphi I stage. Regarding constipation, they were below of the recommended, for the protocol to be considered valid in Delphi I, the items clarity (79.1%) and accuracy (79.1%). It is noteworthy that the items mentioned above did not show statistical significance in the agreement among judges. It should be noted that judges’ suggestions in the first round (Delphi I) for the items that needed to be revised were regarding their form of presentation, inclusion, exclusion, relocation or division (Include Bristol Scale, standardize algorithm wording, review wording, remove action, manually remove fecal impaction, if necessary, as recommended by the Federal Council of Nursing; this action can be performed by nurses as long as it is registered in an institutional protocol).

In the flowchart, with the graphic algorithm and care guidelines for AC-induced inappetence, for telephone follow-up to reduce the side effect of inappetence related to AC for people with gastrointestinal cancer, content was clearly, unequivocally and relevantly explained (boxes were separated about lack of appetite and other symptoms; writing has been revised; there was an improvement in relation to colors and an increase in the size of the font used; guidelines for professionals and patients were included; guidelines were included regarding the use of non-abrasive toothpaste and mouthwashes with 0.9% saline solution or 3% carbonated water four to six times a day; content that was not exclusive to inappetence was removed).

In the care protocol for telephone follow-up to reduce nausea and vomiting associated with AC for people with gastrointestinal cancer, judges’ suggestions were regarding its form of presentation, inclusion of instructions and relocation (high and moderate drugs were changed emetogenic degree for treatment protocols with high and moderate emetogenic degree; questions were included that assess the risk of dehydration; actions were oriented to patients and/or family members were separated from exclusive actions of nurses; and content wording was revised).

Regarding the care protocol for telephone follow-up of AC-induced diarrhea for PNMGTAA, judges’ recommendations allowed the desired goal to be reached. The Bristol Scale was added, guidance for after evacuation, washing the region with soap and water and drying with a soft towel, without friction, and scientific basis. This last item was added to all care protocols.

In the Delphi II round, all requirements showed agreement above 80.0% and were statistically significant (ρ≤0.05), which corresponds to agreement among judges. In addition, after judges’ suggestions (Delphi II), modifications were essential only in relation to the color of algorithms’ graphic forms, in order to make them more prominent and differentiated in the care protocols. It is noteworthy that, at the end of Delphi II, the care protocols were valid (lack of appetite [CVC = 0.98]; nausea and vomiting [CVC = 0.99]; diarrhea [CVC = 0.99]; and constipation [ CVC = 0.98]).

Finally, there was no objection from the judges regarding the recommendation for the use of care protocols in clinics where AC is administered. In Delphi II, 100.0% made the recommendation without the need for changes.

Discussion

AC offers great benefit to people with malignant neoplasms. In general, therapeutic and toxic doses are very close, and( ⁴ , ⁷ )is associated with a myriad of symptoms and side effects from treatment that can range from mild to potentially fatal, severe and disabling.( ⁶ )

Therefore, early recognition and effective management of these symptoms by health professionals, patients and family members are essential to reduce the sequelae of physical and psychological treatment. However, most patients receive AC in an outpatient setting and are therefore compelled to manage side effects at home without direct support from cancer health professionals. Thus, the use of home telephone follow-up can be a key factor in cost-effective health care.( ⁶ , ⁷ )

The care protocols, from two Delphi stages, were considered valid in their content (lack of appetite [CVC = 0.98]; nausea and vomiting [CVC = 0.99]; diarrhea [CVC = 0.99]; and constipation [CVC = 0.98]), are acceptable to consider valid. Therefore, the protocols proved to be valid; and its application can contribute to health promotion, as it is a tool that aims to improve the quality of care, reduce adverse events, support therapeutic adherence and improve communication between patients and nurses. It involved the participation of 16 judges in Delphi I (DI) and 12 in Delphi II (DII) stages, with a view to making the care protocols reliable and valid with regard to content and appearance. Validity is an essential criterion for validating the quality of an instrument.( ¹¹ , ²¹ , ²² )

As for preeminence of females (87.5% - DI and 83.5% - DII) among the judges participating in this research, a study( ²³ )showed that this fact has followed the profession since the beginnings of nursing history, since it is one of the feminized health professions and maintains the relationship between “care” and “feminine action”. Around 85.0% of nursing professionals are women.( ²³ , ²⁴ )

The experience of the judges participating in the assessment phases stands out, who were doctors with extensive experience in cancer care, management, research and teaching. From this angle, literature shows that holders of masters’ and PhD degrees are the main responsible for enabling repercussions on practices and, consequently, on the advancement of nursing.( ¹¹ , ²⁵ )

Therefore, it is understood that the participation of experienced professionals involved in cancer care, management, research and teaching is vehemently relevant for the validation of protocols to be applied in practice, as this study proposed when validating assistance protocols for telephone follow-up assistance in reducing the side effects associated with AC.

In the validation process of care protocols, the final product of this research, the judges presented a significant coefficient of agreement in all items assessed, in order to make the instrument valid in relation to the assessment of usefulness/relevance, objectivity, simplicity, clarity, relevance, accuracy, variety, consistency, feasibility, updating, accuracy, and behavior.( ¹⁴ )This certifies that the instrument is suitable for a reliable practical applicability.

With regard to CVC, it can be inferred that there was a consensus among participants in the care protocol validity judgement, as well as it was considered that the assessed instrument supplies content for telephone follow-up in the reduction of side effects (lack of appetite, nausea and vomiting, diarrhea and constipation) associated with outpatient AC for people with gastrointestinal malignant neoplasm. This reality is proven by the agreement obtained among judges in the assessment of inappetence (CVC: DI - 0.90 and DII - 0.98), nausea and vomiting (CVI: DI - 0.89 and DII - 0, 99), diarrhea (CVI: DI – 0.87 and DII – 0.99), and constipation (CVI: DI – 0.84 and DII – 0.98). They were statistically significant (ρ ≤ 0.05), which denotes the achievement of better consensus associated with improvements in the protocols between Delphi rounds.

Despite the rigor in assessing content and appearance of care protocols, it is necessary to proceed with the consecutive phases, for operational and measurement equivalence. Therefore, its application was started in a large Brazilian hospital, qualified as a High Complexity Oncology Care Unit (UNACON - Unidade de Assistência de Alta Complexidade em Oncologia ) so that it is possible to verify its efficiency.

The limitation of this study is related to the specificity of the protocols for telephone follow-up in reducing only the side effects of inappetence, nausea and vomiting, diarrhea and constipation associated with outpatient AC for people with gastrointestinal malignancies. Therefore, it is recommended that further research be carried out for the construction and validation of protocols aimed at other side effects.

Even so, this research will contribute substantially to raising professionals’ attention regarding the importance of adjustments to provide outpatient care with greater interaction between health professionals and patients, in addition to enabling the control of some adverse effects, through telephone monitoring based on scientific evidence.

Conclusion

The validation process of care protocols enrolled 16 judges in Delphi I, who judged that only the items related to the constipation side effect were not adequate in terms of clarity (79.1%) and accuracy (79.1%), even so a CVC of 0.84 was obtained. In the second Delphi round, 12 judges were included, and the validation of protocol content and appearance was achieved (lack of appetite [CVC = 0.98]; nausea and vomiting [CVC = 0.99]; diarrhea [CVC = 0.99]; and constipation [CVC = 0.98]). Based on the results, it was proven that the protocols are reliable and valid in terms of content and appearance to be submitted to clinical validation in the practice of outpatient services.

Appendix 1

. References used as a foundation for protocol construction

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Ferreira EB, Cruz FOAM, Jesus CAC, Pinho DLM, Kamada I, Reis PED. Contato telefônico como estratégia para a promoção de conforto ao paciente submetido a quimioterapia. Rev enferm UFPE on line. 2017; (5):1936-42.
Flannery M, McAndrews L, Stein KF. Telephone calls by individuals with cancer. Oncol Nurs Forum. 2013; 40(5):464-71.
Fox, PA, Darley A, Furlong E, Miaskowski C, Patiraki E, Armes J, et al. The assessment and management of chemotherapy-related toxicities in patients with breast cancer, colorectal cancer, and Hodgkin and non-Hodgkin lymphomas: a scoping review. Eur J Oncol Nurs. 2017; 26:63-82.
Guo M, Wang C, Yin X, Nie L, Wang G. Symptom clusters and related factors in oesophageal cancer patients 3 months after surgery. J Clin Nurs. 2019;28(19-20):3441-50.
Kaminsky E, Röing M, Björkman A, Holmström IK. Telephone nursing in Sweden: A narrative literature review. Nurs Health Sci. 2017; 19(3): 278-86.
Kondo S, Shiba S, Udagawa R, Ryushima Y, Yano M, Uehara T, et al. Assessment of adverse events via a telephone consultation service for cancer patients receiving ambulatory chemotherapy. BMC Res Notes. 2015; 8:315.
Lin WL, Sun JL, Chang SC, Wu PH, Tsai TC, Huang WT, et al. Development and Application of Telephone Counseling Services for Care of Patients with Colorectal Cancer. Asian Pac J Cancer Prev. 2014; 15 (2), 969-73.
Manguire R, Fox PA, McCann L, et al. The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. BMJ Open. 2017; 7: e015016.
Mole G, Murali M, Carter S, David Gore D, Broadhurst J Moore T, Vickers P, Miles A. A Service Evaluation of Specialist Nurse Telephone Follow-Up of Bowel Cancer Patients After Surgery. Br J Nurs. 2019;28(19):1134-38.
Moretto IG, Contim CLV, Espírito Santo FH. Acompanhamento por telefone como intervenção de enfermagem a pacientes em quimioterapia ambulatorial: revisão integrativa. Rev Gaúcha Enferm. 2019;40: e20190039.
Speyer R, Denman D, Wilkes-Gillan S, Chen YW, Bogaardt H, Kim JH, et al. Effects of telehealth by allied health professionals and nurses in rural and remote areas: a systematic review and meta-analysis. J Rehabil Med. 2018;50(3):225-35.
Sprague BL, Dittus KL, Pace CM, Dulko D, Pollack LA, Hawkins NA, et al. Patient satisfaction with breast and coloretal cancer survivorship care plans. Clin J Oncol Nurs. 2013; 17(3)266-72.
Suh SR, Lee MK. Effects of nurse-led telephone-based supportive interventions for patients with cancer: a meta-analysis. Oncol Nurs Forum. 2017; 44(4): E168-E184.
Underhill ML, Chicko L, Berry DL. A Nurse-Led Evidence-Based Practice Project to Monitor and Improve the Management of Chemotherapy-Induced Nausea and Vomiting. Clinical J Oncol Nurs. 2015; 19(1): 38-40.
Wong AD, Kirby J, Guyatt GH, Moayyedi P, Vora P, You J. Randomized controlled trial of standardized education and telemonitoring for pain in outpatients with advance solid tumors. Trials. 2013; 14:40.

Appendix 2 Protocols with the respective graphic algorithm followed by detailed guidelines with nursing interventions

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Edited by

Associate Editor (Peer review process): Edvane Birelo Lopes De Domenico (https://orcid.org/0000-0001-7455-1727) Escola Paulista de Enfermagem, Universidade Federal de São Paulo, SP, Brasil

Publication Dates

• Publication in this collection
  06 June 2022
• Date of issue
  2022

History

• Received
  29 Mar 2021
• Accepted
  29 Sept 2021