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

October 8, 2024 updated by: Yolanda Alvarez-Perez

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Santa Cruz De Tenerife, Spain, 38109
        • Servicio de Evaluación del Servicio Canario de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-arm intervention
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
  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.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately after the intervention
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.
Immediately after the intervention
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
Immediately after the intervention
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)
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yolanda Alvarez-Perez

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Clinic of Barcelona
Universitat Autonoma de Barcelona
University of Barcelona
University of La Laguna
Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias (FIISC)
Parc Taulí Hospital Universitari
Servicio de Evaluación del Servicio Canario de Salud
FEFOC fundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIFIISC 19/24
  • CHUNSC_2019_61 (Other Identifier: Ethics Committee of Hospital Universitario Nuestra Señora de la Candelaria)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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