EVALUATION OF THE FEASIBILITY AND ACCEPTABILITY OF AN EDUCATIONAL INTERVENTION IN NURSING: PROTOCOL OF A PILOT STUDY

Objective: to explain the protocol of a pilot study that aims to evaluate the feasibility and acceptability of a nursing educational intervention to promote health behaviors in cancer survivors. Method: the protocol was developed based on the Standard Protocol Items: Recommendations for Interventional Trials 2013 - SPIRIT 2013 Statement , in Porto, Portugal in 2022. Results: the protocol would support the implementation of the pilot study in order to assess the feasibility and acceptability of the procedures defined for the intervention, estimate the recruitment and retention of participants, and define the sample size so that possible reformulations of the educational intervention could be considered and proceed to the evaluation phase. Conclusion: this study has laid the structural foundations and content for conducting a pilot study and may later influence the decision to conduct a randomized controlled trial.


INTRODUCTION
Cancer survival rates have been steadily increasing.Cancer survivors are defined as people with cancer who have completed treatments with curative intent 1 .During this period, people face adverse effects of cancer and treatments, which can potentiate existing comorbidities, causing worsening psychological distress, greater use of health care services, and higher costs.In addition, there is a higher prevalence of multiple chronic conditions in survivors when compared to similar groups without cancer.In survivors, the risk of developing secondary cancers, cardiovascular, renal, musculoskeletal, and endocrine diseases higher when compared to the population that never had cancer 2 .
Uncertainty about the future provokes feelings of ambivalence in cancer survivors because, on the one hand, they feel they must engage in healthy behaviors, but on the other hand, the fears imposed by the disease create very difficult conditions that prevent them from understanding their needs and capabilities.In this sense, although survivors report making health behavior changes, they rarely self-initiate behavioral changes 3 .Therefore, the Centers for Disease Control and Prevention recommends that people with cancer should receive an individualized survivorship care plan that includes guidelines for monitoring and maintaining health 4 .
From this perspective, nurses are professionals capable of implementing educational interventions making survivors engage in relevant self-care practices.These interventions in survivors refer to individualized support from nurses to individuals in the transition from the cancer center to the community, helping them anticipate issues related to their own health 5 .
Although there is evidence that educational nursing interventions enhance cancer survivors' health and quality of life, minimize long-term risks, and reduce the risk of recurrence, many actions need to be taken to avoid gaps 5 .In Portugal, the National Program for Oncologic Diseases reinforces that survivors have needs 6 , but does not present goals, strategies, or action plans.
The educational interventions found in the literature that focus on improving health behaviors in survivors are relevant; however, they are not adapted to the Portuguese population 7 .These actions fall within the conceptual models of complex interventions and should include a vital preliminary and preparatory assessment, the piloting.Piloting includes procedures for testing acceptability, estimating likely recruitment and retention rates, and calculating sample sizes that reflect adequate analysis before the evaluation phase 8 .This article aims to explain the protocol of a pilot study, in which the purpose is to design the evaluation of the feasibility and acceptability of a nursing educational intervention to promote health behaviors in cancer survivors.
The protocol was developed to plan the assessment of the a) Feasibility recruitment and study procedures, b) Fidelity of the intervention, and c) Acceptability of the intervention and pilot study procedures.The protocol includes a secondary evaluation that will influence the decision to proceed with a randomized controlled trial.
A protocol was developed based on the SPIRIT2013 Statement 9 (version 1.0 dated 07.15.2022).The SPIRIT2013 Statement provides recommendations for defining the minimum content of a clinical trial protocol and is widely used as an international standard 9 .The pilot study protocol presented, describes a single-group study, with the following research question: What is the acceptability and feasibility of the Nursing Educational Intervention to promote Health Behaviors in Cancer Survivors?The educational intervention will be implemented in a hospital in Portugal.The intervention is based on the Health Promotion Model 10 , includes a set of eight educational sessions conducted by specialist nurses, and includes the necessary ethical and legal aspects 11 .

METHOD
The study encompasses two types of samples, the specialist nurses, and the cancer survivors.The sample size of survivors (n=30) is lined up with international recommendations 12 .The recruitment will be done by the nursing team of an outpatient service of the hospital, in order of referral, who will invite the users who meet the eligibility criteria.Survivors who agree to participate will be referred to the research team, which will conduct an initial screening to verify eligibility, present the study, and sign the informed consent.The eligibility criteria for survivors are presented in Chart 1.

Inclusion criteria
Be an adult (age > 18 years).Have a diagnosis of oncologic disease.Be in the last 3 sessions of treatment with curative intent.Be willing to participate in the sessions.Be willing to sign a health contract.

Exclusion criteria
Inability to speak, read or write in Portuguese.Medical contraindication for physical exercise.Having altered cognitive capacity that does not allow decision making and/or limits the understanding of the information transmitted.Having had tumor or tissue extraction surgery less than 1 month ago.Being in the palliative phase.Having a diagnosis of uncompensated psychiatric illness.
The specialist nurses (five) who will perform the intervention will be recruited from an outpatient service of the hospital (Day Hospital).In order to be eligible, they should: a) be specialist nurses in Medical-Surgical Nursing registered in the "Ordem dos Enfermeiros" (Portuguese Nurses Association), regardless of their employment status and years of work, b) reveal availability, c) agree to participate, d) participate in a two-hour training session held by the researchers, e) follow the session guidelines provided by the researchers, f) accept the researchers' supervision, and g) participate in a debriefing.
Eligible survivors and nurse specialists will receive an email requesting their participation in the study and informing them about the objectives, duration and intervention procedures.After agreeing to participate, they will be contacted by phone to schedule the first session and the two-hour training session, respectively.The intervention will take place over eight weeks, with weekly sessions, which can be a) group or b) individual or with a family member (Charts 2 and 3).
The educational intervention will be supported by the Health Promotion Model 10 , encompasses professional actions related to engagement, adherence to the plan, motivation, and self-efficacy 10 .The sessions are composed of a set of focus, i.e., area of nursing care, and interventions previously validated by a group of experts 13 and built based on the International Classification for Nursing Practice (ICNP) 14 .The sessions (Chart 4) will be conducted by the interventionist nurses after previous preparation, provided by the researchers, and according to the flowchart shown (Figure 1).
The individual sessions (one, two and eight) will take place in an office, lasting 30 minutes.Survivors may choose to have a family member present.In these sessions, nurse interventionists focus on the affect and cognitions of behavior change, individual goal setting, and the construction of an individualized behavior change plan.
In session one the health contract will be presented to the participant, in session two the contract will be signed by both.In Session eight the nurse interventionist will reinforce the benefits of behavior change and identify the incentives for maintaining the health behaviors by remembering the signed contract.
The group sessions (three to seven) will be held in an auditorium, will have a duration of one hour and will include an expository approach to health promotion concepts, sharing experiences and strategies to promote motivation and involvement.In these five group sessions the benefits, potential risks, and recommendations of health-promoting behaviors such as exercise, nutrition, weight status, and substance abuse will be presented.Available health resources, the benefits of professional support, and the importance of support groups will be presented.In every group session participant will be reminded of the content of the previous session.Participants will use the group to share experiences, strengthen self-efficacy, and receive peer support.During the group sessions a researcher will be present but will not intervene.Participants who miss individual sessions will be rescheduled.If any participant misses a group session, the content and objectives of the session will be sent to the participant to minimize loss of follow-up.

Office
The evaluation of the fidelity of the intervention involves determining whether it is possible to carry out the intervention as planned (intervention delivery) 8 .To do this, sessions will be audio-recorded, transcribed, coded, and analyzed by two members of the research team.An intervention content verification matrix will be used to evaluate the delivery of the intervention, verify the aspects addressed by the Interventionist nurse, guide the wording of the items in the sessions' document, facilitate the assessment of adherence, and validate the Interventionist Nurses' competence to carry out the intervention 15 .If there is deviation in the delivery of the intervention, meetings will be held with the nurse specialists for analysis and standardization of procedures before implementation in the randomized controlled trial.
The acceptability of the intervention and study procedures will be evaluated both quantitatively and qualitatively.Considering the recommendations 8 .It was defined that: (a) Acceptability Questionnaire of seven dimensions on a five-point Likert scale will be applied to participants and intervention nurses: 1) affection; 2) perceived effort to complete the intervention; 3) ethical issues; 4) opportunity; 5) perceived effectiveness; 6) self-efficacy; and 7) impact of the intervention b) Interviews will be conducted with 10 participants to obtain their opinions and experiences with the intervention, including what they perceive as barriers and facilitating factors of the intervention.c) Interviews will be conducted with 3 Nurse Interventionists immediately following the conclusion of the intervention period to explore the acceptability of the intervention.The interviews will allow the nurses to share stories and challenges, to discuss the skills they must improve to develop this type of intervention, to discuss the use of the session tracking documents and the ontology used.

Secondary Evaluation
Relative to the secondary assessment, an assessment of Quality of Life and variability of health behaviors will be performed.It will be used: a) the Health-Promoting Lifestyle Profile-II (HPLP-II) 16 translated and validated for the Portuguese population in 2015 17 -a questionnaire composed of 52 items divided into six subscales that allows monitoring behaviors in the theoretical dimensions of the health-promoting lifestyle, namely spiritual growth, interpersonal relationships, nutrition, physical activity, responsibility for health and stress management 16 ; b) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 18 translated and validated for the Portuguese population in 2008 19 -a 30-item instrument widely used in assessing QoL of adults with cancer and may allow comparability with other studies (18) ; c) a five-item Likert scale to assess alcohol consumption and tobacco use; d) Body Mass Index and, e) participants' body weight.

Data collection, management, and analysis
The collection, management and analysis of the primary and secondary data will allow inferring the possibility of implementing the educational intervention in a randomized controlled trial.Primary data collection will occur in different ways and at different times (Figure 1), namely through: 1) collecting data regarding participation in the sessions, 2) audio recording the sessions, 3) applying questionnaires and conducting interviews with the participants and intervention nurses after the intervention.
The analysis of the feasibility data, especially the percentages of recruitment, adherence, and intervention completion rates, will allow us to understand, among other things, if the recruitment of participants is adjusted.If a recruitment rate of more than 80% is not achieved, the participant screening data will be analyzed to see if too few potential participants were contacted, if the recruited participants did not meet the eligibility criteria, or if they simply did not want to participate in the study or did not accept the conditions of the study.
The analysis of the data concerning acceptability will result from the application of the Acceptability Questionnaire of seven dimensions to the participants and interventionist nurses, but also from the content analysis of the interviews conducted with them, according to Bardin's methodological assumptions 20 .The interviews will be transcribed by members of the research team.The transcriptions will provide data on the participants' and interventionist nurses' perceptions of the intervention.Data on the affection, opportunity, impact, and effort generated by the intervention on participants and nurses will allow researchers to optimize and restructure the intervention.
For the analysis of the fidelity of the intervention, all sessions will be recorded, transcribed, and compared.The text excerpts of the recordings will be allocated to a verification matrix of the intervention's content to assess the operationalization of the intervention, in other words if it includes the items selected for the session, if the interventionist nurses follow the protocol and if participants feel their needs were met.We also intend to verify the skills that interventionist nurses use or need to improve, to optimize the formative session, which was performed by the researchers prior to the intervention.
Secondary data collection will be performed through the instruments already mentioned in three moments: the first before the intervention (T0-before the first session), the second after the last session of the intervention (T1), and the third three months after the end of the intervention (T2) to put into perspective the changes in Quality of Life (QoL) and variability of health behaviors imposed by the intervention.Data will be grouped and will be subject to quantitative analysis.

Ethical Aspects
The protocol was built based on the Helsinki Declaration 11 .The investigation project was submitted to the joint Ethics Committee of CHUPorto and Instituto de Ciências Biomédicas Abel Salazar (ICBAS)-University of Porto and was approved under reference 2020/CE/P009(P321/CETI/ICBAS).The consent of all participants is essential through the signature of a free, voluntary, and informed consent form.Confidentiality will be ensured, and participants may withdraw from the research at any time if they wish.The data will be used only for the intended purpose and will be destroyed later.The intervention presented was not recorded in any platform intended for this purpose.

RESULTS
As a pilot study protocol, the results are only expected.The protocol will support the implementation of the pilot study to assess the feasibility and acceptability of the procedures defined for the intervention, to estimate recruitment and retention of participants, and to define the sample size so that possible reformulations of the educational intervention can be considered and proceed to the evaluation phase 8 .
With the mixture of previously selected data collection methods, it is expected that the primary results of the study will support the understanding of the fidelity of the intervention and its acceptability, and that the barriers, affection, perceived effectiveness, and impact of the intervention on participants and intervention nurses will be understood.Secondary data will allow us to interpret changes in participants' QoL and health-promoting behaviors and put into perspective their variability when the intervention is applied in a clinical trial.

DISCUSSION
Educational intervention provides cancer survivors with an individualized educational plan and ongoing professional support for health behavior change, essential to prevent cancer-associated comorbidities and improve quality of life.
The structure and content of the planned intervention has a strong influence on the central aspects of behavior change 10 , which leads to participants feeling more motivated and involved and better understanding the benefits and barriers to action, improving selfefficacy, and developing feelings related to the action itself.
The nurse-participant health contract promotes an environment of co-responsibility, with shared decision-making, and the survivor feels an integral and active part of their health project 21 .Health contracts provide health gains, psychological comfort, and a better understanding of what they are expected to do 22 .
A strength of the intervention is its ICNP 14 structuring, as it produces a standard of documentation with international replicability 23 .A possible barrier to the intervention is the preparation and standardization of skills of the intervention nurses that may affect the delivery of the intervention.However, given that the focus is on the survivor and the survivor-nurse relationship, no acceptability assessment activities were developed with family members, and this is a limitation of the study.Results will also be limited by the lack of a control group.
Cogitare Enferm.2023, v28:e90807 Evaluation of the feasibility and acceptability of an educational intervention in nursing: protocol of a pilot study Peixoto NM dos SM, Peixoto TA dos SM, Pinto CAS, Santos CSV de B.
Chart 4 -Domains, objectives, and materials of the sessions.Porto, District of Porto, lHealth Behavior Change II lReinforce the benefits of change and identify the incentives for change from the survivor's perspective.lAddress environmental and interpersonal facilitators and barriers to behavior change.lDefine with the survivor a plan implementation period.lFormalize a commitment to the behavior change goals and make available the support needed to achieve them.lSign the health care contract.lEnhance engagement, motivation, and self-efficacy.lEnable the sharing of experiences.lEnable the sharing of feelings associated with action.lVerify achievement of behavior change goals.lReinforce the benefits of change and identify incentives for maintaining behaviors.lRecall the health care contract.