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Completed

NCT Number: NCT06635239

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Evaluación del Servicio Canario de la Salud

Santa Cruz de Tenerife, 38109, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • No exclusion criteria were applied based on diagnosis date, current or past treatment, nationality, Health Literacy and Digital Health Literacy level and knowledge about Person-Centred Care or breast cancer.
  • In the assessment of the MOOC's acceptability and effectiveness, participants involved in co-creating the MOOC will be excluded.

Treatment and study plan

Co-creation and assessment

Other
  • 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.
  • 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.)

Primary outcomes

  1. Digital Health Literacy

    Time frame: Immediately after the intervention

    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.

  2. Health Literacy

    Time frame: Immediately after the intervention

    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.

  3. Knowledge acquired

    Time frame: Immediately after the intervention

    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

  4. Acceptability of MOOC

    Time frame: Immediately after the intervention

    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)

Sponsors and collaborators

Lead sponsor

Yolanda Alvarez-Perez

Other

Collaborators

  • FEFOC fundation
  • Fundación Canaria Instituto de Investigación Sanitaria de Canarias
  • Hospital Clinic of Barcelona
  • Parc Taulí Hospital Universitari
  • Servicio Canario de Salud
  • Universitat Autonoma de Barcelona
  • University of Barcelona
  • University of La Laguna

Registry information

Official study title

Massive Open Online Course for Women With Breast Cancer: Development and Evaluation of an Intervention on Person-Centered Care and Digital Health Literacy in Breast Cancer

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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