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临床试验/NCT05270252
NCT05270252已完成不适用

Educational Intervention in Nursing Students for the Care of Long-term Cancer Survivors and Their Families: An Exploratory Randomized Controlled Trial

Clinica Universidad de Navarra, Universidad de Navarra2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
2
主要终点
Attitude

研究概览

简要总结

The study aims to determine the feasibility and acceptability of an interdisciplinary educational intervention for nursing students to acquire the competence (knowledge, skill and attitude) to care for long-term cancer survivors and their families.

The design is an exploratory randomized controlled trial Following the framework of the Medical Research Council, the method used is a multidisciplinary educational intervention consisting of a flipped classroom, a clinical simulation and a round table with a duration of ten hours. The variables to measure effectiveness were competence and its attributes: knowledge, skills and attitude. The variable to assess acceptability and feasibility was student satisfaction. Data were collected before and after the intervention.

详细描述

The study was designed following the framework of the Medical Research Council (MRC) , for complex interventions. The study participants were 3rd-year Nursing bachelor students from the University of Navarra (Spain). The educational intervention was called Learning & Care, and it was framed within the European Higher Education Area.

For the design of the intervention, the following steps were followed within the MRC framework: (1) review of the literature to know the educational methodologies used in the field of health for the care of patients with cancer and exploration of the different conceptual models of family nursing, (2) design and development of an educational intervention proposal developed by the researchers of the study, and (3) the evaluation of the intervention proposal by a multidisciplinary Expert Panel composed of 11 members: five nurses (primary care, researchers, teachers and hospitalization), a medical oncologist, a psycho-oncologist, a pharmacist, a student, a cancer survivor and a family member of a cancer survivor. With the suggestions of the panel, the final educational intervention was developed, and the exploratory and piloting study was carried out.

The data collection lasted from February to April 2021, a period in which the students did not have exams. Sociodemographic information of all participants (intervention and control group) was collected only at baseline using a researcher-developed questionnaire that included variables such as: age, sex, previous study of some degree (it is common in Spain to do double degrees), previous courses or training related to family nursing and experience as healthcare worker (this last information was collected because some students work as nursing assistants while studying the Bachelor's degree).

In addition, data was collected on the level of knowledge, skills and attitude of the students to carry out care focused on the cancer survivor and his family, both in the Control group (CG) and in the Intervention group (IG) before and after the educational intervention with the IG. At the end of the training with the IG, the data from the IG and GC on student satisfaction were collected.

The students completed the sociodemographic information and the data on knowledge and attitude through the online platform Google Form. The principal researcher collected the data on the students' skills on a tablet. Lastly, the level of student satisfaction with the program was collected on site and on paper once the training program was completed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants were blinded in their group assignment; means were put in place to maintain blinding of students throughout the study.

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Students enrolled in the 3rd year of nursing at the Faculty of Nursing of the University of Navarra and who voluntarily agree to participate in the study

排除标准

  • 1st and 2nd year nursing students since they had not had contact with clinical practice.
  • 4th year nursing students due to being in a clinical practice period and being outside the institution where the intervention was carried out.

结局指标

主要结局

Attitude

时间窗: February-April (3 months)

To measure attitude, the FINC-NA scale (Barreto et al., 2022) was used, which has been widely used to measure the attitude of nurses to involve families in care. The scale consists of 26 evaluable items in a range between 1 and 4 points, organized into 4 groups: (1) Family as another resource for nursing care, (2) Family as collaborator in dialogue, (3) Family as burden and ( 4) Family as their own resource. For the calculation of the "family as a burden" group, the data were inverted (Hagedoorn et al., 2020). The total value of the attitude scale is 104 points. This scale is validated in Spanish in a sample of 274 professionals and obtained a total Cronbach's alpha coefficient of 0.864 for the total scale, ranging between 0.888 and 0.769 in the subscales. The factorial analysis identified 4 factors that explained 54.22% of the total variance (Pascual Fernandez et al., 2015).

Skills

时间窗: February-April (3 months)

The Van Gelderen Family-Care Rubric Scale (VGFCR) was used (Van Gelderen et al., 2019). The VGFCR is made up of 12 evaluable items, each one between 1 and 3 points. The scale groups the items into two groups: communication in the family and the family as a client. In each of the groups you can get a maximum score of 18 points. The total skill value is 36. In general, reliable VGFCR was determined with Fleiss' Kappa significance at p = 0.05 at the 95% confidence interval and Cronbach's alpha 0.842. This scale is available in English, permission was requested from the author to translate it into Spanish and I use the study. The linguistic-cultural adaptation was carried out through the direct and inverse translation methodology (Bracken \& Barona, 1991). Once the double translation was done, the scale translated into Spanish was sent to the main author, who agreed.

Knowledge

时间窗: February-April (3 months)

To assess the level of knowledge acquired by students about the needs of long-term survivors and their families, as well as about family nursing and family assessment and intervention tools according to the Calgary Model, an ad hoc multiple choice test was designed. 20 multiple choice questions. The test was piloted among team members and students to validate their understanding and identify possible errors in multiple responses.

次要结局

  • student satisfaction(February-April (3 months))

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Sponsor

研究点 (2)

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