Educational Intervention for Cancer Survivorship Care.

NCT05270252 | Completed DMC

• 1 other identifier: EICS
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Students

Keywords

Long-term survivor, cancer, family; educational intervention, interdisciplinary,; educational methods

Outcome Measures

Primary Outcomes (3)

• Knowledge

  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.

  February-April (3 months)

• Skills

  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.

  February-April (3 months)

• Attitude

  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).

  February-April (3 months)

Secondary Outcomes (1)

• student satisfaction

  February-April (3 months)

Study Arms (2)

Control group

NO INTERVENTION

no intervention

Intervention group

EXPERIMENTAL

Interdisciplinary educational intervention with a combination of active educational methods.

Other: Learning and Care

Interventions

Learning and Care OTHER

The educational intervention lasted 10 hours: six face-to-face and four for personal study. Three educational methodologies were combined. The first: flipped classroom. Students received training material in their email: articles on the needs of families / cancer survivors and family nursing according to the Calgary Model (Wright \& Leahey, 2013) and experiential videos of survivors and family members. In the classroom, a week later, a nurse promoted students' self-learning and reflection. The second: simulation clinical case. The students received by email a summary of the case and material for their personal work. Students in groups of three performed the entire clinical scenario. The third: round table. The components were advanced practice nurse, medical oncologist, cancer survivor and a family member. The content revolved around personal experience in caring for family members and cancer survivors and the interdisciplinary work required for this care.

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (9)

• 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.

  PMID: 34593508 BACKGROUND

• 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.

  PMID: 25766206 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35083808 BACKGROUND

• 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.

  PMID: 33270268 BACKGROUND

• 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.

  PMID: 18824488 RESULT

• 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.

  PMID: 33352353 RESULT

• Domingo-Osle M, La Rosa-Salas V, Garcia-Vivar C. Educational Intervention for Family Nursing Students in Long-Term Cancer Survivorship: A Randomized Pilot Trial. J Fam Nurs. 2023 Aug;29(3):248-262. doi: 10.1177/10748407231167438. Epub 2023 May 21.

  PMID: 37211798 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Marta Domingo

  Clinica Universidad de Navarra, Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded in their group assignment; means were put in place to maintain blinding of students throughout the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 8, 2022
• Study Start: January 9, 2021
• Primary Completion: April 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 8, 2022

Record last verified: 2021-12

Locations

ES (1)