Clinical trial NCT05270252: Educational Intervention for Cancer Survivorship Care.
Official title: Educational Intervention in Nursing Students for the Care of Long-term Cancer Survivors and Their Families: An Exploratory Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Students
Keywords: Long-term survivor, cancer, family
educational intervention, interdisciplinary,
educational methods
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 69
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed following the framework of the Medical Research Council (MRC) (Craig et al., 2019), for complex interventions.

The sample size was estimated in at least 58 participants assuming a percentage of potential losses of 10%.

The recruitment period was from January-February 2021. After receiving permission of the University and approvals from the Ethics Committee (REF. 2020.161), the principal researcher presented the project to the students with a brief oral presentation supported by video. The students who agreed to participate scanned a QR code through which they could request information indicating a contact email.

Students who requested information, and who met the inclusion criteria, were sent a project information sheet, as well as a Doodle to sign up for the first session. Before the first session, they signed the informed consent and the sociodemographic data were collected through a Google Form questionnaire.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Knowledge
timeFrame: February-April (3 months)
measure: Skills
timeFrame: February-April (3 months)
measure: Attitude
timeFrame: February-April (3 months)
Secondary outcomes:
measure: student satisfaction
timeFrame: February-April (3 months)
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clinica Universidad de Navarra, Universidad de Navarra
name: Marta Domingo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
citation: Wright LM. Brain science and illness beliefs: an unexpected explanation of the healing power of therapeutic conversations and the family interventions that matter. J Fam Nurs. 2015 May;21(2):186-205. doi: 10.1177/1074840715575822. Epub 2015 Mar 12.
citation: Gelderen, S. Van, Engebretson, A., Miller, A., Hancock, A., Ehmke, S., Swan, M., & Garrow, A. (2019). A Family-Care Rubric : Developing Family Care and Communication Skills Using Simulation. Clinical Simulation in Nursing, 36, 47-58. https://doi.org/10.1016/j.ecns.2019.07.006
citation: Bracken, B. A., & Barona, A. (1991). State of the Art Procedures for Translating, Validating and Using Psychoeducational Tests in Cross-Cultural Assessment. School Psychology International, 12(April 1991), 119-132. https://doi.org/10.1177/0143034391121010
citation: Barreto MDS, Marquete VF, Camparoto CW, Garcia-Vivar C, Barbieri-Figueiredo MDC, Marcon SS. Factors associated with nurses' positive attitudes towards families' involvement in nursing care: A scoping review. J Clin Nurs. 2022 Dec;31(23-24):3338-3349. doi: 10.1111/jocn.16226. Epub 2022 Jan 26.
citation: Hagedoorn EI, Paans W, Jaarsma T, Keers JC, van der Schans CP, Luttik MLA. The importance of families in nursing care: attitudes of nurses in the Netherlands. Scand J Caring Sci. 2021 Dec;35(4):1207-1215. doi: 10.1111/scs.12939. Epub 2020 Dec 3.
citation: Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
citation: Domingo-Osle M, La Rosa-Salas V, Ambrosio L, Elizondo-Rodriguez N, Garcia-Vivar C. Educational methods used in cancer training for health sciences students: An integrative review. Nurse Educ Today. 2021 Feb;97:104704. doi: 10.1016/j.nedt.2020.104704. Epub 2020 Dec 7.