Massive Open Online Course (MOOC) for Women with Breast Cancer

NCT06635239 | Completed DMC

• 2 other identifiers: PIFIISC 19/24CHUNSC_2019_61
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to promote Person-Centered Care and improve Health Literacy and Digital Health Literacy in women with breast cancer through the development of a Massive Open Online Course (MOOC) co-created with women with breast cancer.

Conditions

Breast Cancer

Keywords

Massive Open Online Course; Digital Health Literacy; Health Literacy; Person-Centered Care

Outcome Measures

Primary Outcomes (4)

• Digital Health Literacy

  Digital Health Literacy through the eHealth Literacy Scale (eHEALS). It is an 8-item scale that uses a 5-point Likert scale to answer each question with response options ranging from "strongly agree" to "strongly disagree", resulting in a total score ranging from 8 to 40.

  Immediately after the intervention

• Health Literacy

  Health Literacy through the Health Literacy Survey European Questionnaire-16 items (HLS-EU-Q16). It is an abbreviated version of the Health Literacy Survey European Questionnaire (HLS-EU-Q) and consists of 16 items, with each question answered by choosing one response from the options: 'very difficult', 'fairly difficult', 'fairly easy', and 'very easy' giving a total score from 16 to 64.

  Immediately after the intervention

• Knowledge acquired

  Knowledge acquired before study each unit of the MOOC using a scale designed specifically for the study and in accordance with the content of each unit

  Immediately after the intervention

• Acceptability of MOOC

  Acceptability (usability, areas for improvement, etc.) of the MOOC using a scale designed specifically for the study, adhering to the methodology of the technology acceptance model (TAM)

  Immediately after the intervention

Study Arms (1)

Single-arm intervention

EXPERIMENTAL

Co-creation with women with breast cancer, their families, and healthcare professionals of a MOOC aimed at women with breast cancer; and evaluation of the MOOC's effectiveness and acceptability.

Other: Co-creation and assessment

Interventions

Co-creation and assessment OTHER

1. MOOC co-creation: development of a MOOC initially structured into modules consisting of a variety of downloadable educational resources such as videos, audios, infographics, texts, etc., covering several units related to Person-Centered Care (Shared Decision-Making, strategies for managing the clinical encounter, Patient Decision Aids, etc.) and Digital Health Literacy (skills, tools, etc.). These resources will serve as the central focus of the educational intervention, and may undergo appropriate adjustments established during the co-creation sessions. 2. MOOC acceptability and effectiveness: evaluation of the MOOC in terms of effectiveness (level of Health Literacy, Digital Health Literacy, and knowledge acquired) and acceptability (usability, areas for improvement, etc.)

Single-arm intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women ( ≥18 years old)
• Speak Spanish
• With internet at home or smartphone
• Currently have or have had breast cancer (currently disease-free)
• Families/caregivers of women with breast cancer and healthcare professionals involved in breast cancer management (oncologists, gynaecologists, nurses, psycho-oncologists, etc.)

You may not qualify if:

• In the assessment of the MOOC's acceptability and effectiveness, participants involved in co-creating the MOOC will be excluded.

Sponsors & Collaborators

• Yolanda Alvarez-Perez: lead
• Servicio de Evaluación del Servicio Canario de Salud: collaborator
• Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias: collaborator
• University of La Laguna: collaborator
• University of Barcelona: collaborator
• FEFOC fundation: collaborator
• Parc Taulí Hospital Universitari: collaborator
• Hospital Clinic of Barcelona: collaborator
• Universitat Autonoma de Barcelona: collaborator

Study Sites (1)

Servicio de Evaluación del Servicio Canario de la Salud

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38109, Spain

Location

Related Publications (1)

• Alvarez-Perez Y, Duarte-Diaz A, Toledo-Chavarri A, Abt-Sacks A, Ramos-Garcia V, Torres-Castano A, Rivero-Santana A, Perestelo-Perez L. Digital Health Literacy and Person-Centred Care: Co-Creation of a Massive Open Online Course for Women with Breast Cancer. Int J Environ Res Public Health. 2023 Feb 22;20(5):3922. doi: 10.3390/ijerph20053922.

  PMID: 36900935 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 10, 2024
• Study Start: January 17, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)