Web-based Oncofertility Support Tool for Reproductive-age Women With Breast Cancer

October 19, 2021 updated by: Chin-Tsung Shen, Mackay Medical College
The aim of this study was to develop electronic systems (e-systems) for oncofertility support, and to examine the comprehensibility, feasibility, usability, and effects on social support and preparation for decision-making.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: When reproductive-aged women with breast cancer lack support in making decisions about fertility, this results in conflicts in decision-making with negative effects on their mental health.

Objective: The aim of this study was to develop electronic systems (e-systems) for oncofertility support, and to examine the comprehensibility, feasibility, usability, and effects on social support and preparation for decision-making.

Methods: The study steps were guided, tested, and utilized to (a) identify the requirements of a patient, (b) guide the development of support interventions, and (c) evaluate the quality of web-based oncofertility support. Both qualitative and quantitative data were collected to explore supportive requirements related to oncofertility care, and an initial website concerning oncofertility was developed based on the resulting requirements and system review regarding social support. Alpha testing and beta testing were used to ensure the quality of the web-based oncofertility support tool. The effectiveness was evaluated using the Preparation for Decision-Making Scale and Social Support Questionnaire.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • 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

  • Taiwan
      • New Taipei City, Taiwan
        • Department of Nursing

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

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health provider who ever cared the patients with breast cancer.
  • Patients with breast cancer aged between 20 and 45.

Exclusion Criteria:

  • Patients of severe psychiatric disorders.
  • Patients under 20 years old.

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
Intervention / Treatment
Experimental: Web-based oncofertility support tool

User-centered design practices were used to develop an oncofertility support website for women with breast cancer before treatment. The steps of the Ottawa Decision Support Framework were used throughout the development process. A multidisciplinary steering group was assembled, and the input was provided. Guidelines from the International Patient Decision Aid Standards were applied to test the quality of the oncofertility support website.

Three steps included:

  1. Identify the supportive needs of a patient;
  2. Guide the development of support interventions;
  3. Evaluate the quality of web-based oncofertility support.
Device: Web-based oncofertility support tool
The website structure was developed to satisfy the needs of reproductive-age women was investigated based on four domains of social support, as developed by Cohen and Syme (1985). The important needs of patients can be classified as emotional, informational, appraisal, and instrumental support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of social support rated before and after using the web-based tool by patients
Time Frame: 4 months
Social support was measured using a 16-item Likert-type questionnaire rating (from 0-3). Women of reproductive age were instructed to complete the social support questionnaire, assessing four dimensions of social support: emotional, informational, appraisal, and instrumental, before and after using the web-based tool.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preparation for Decision Making (PrepDM) evaluated by patients and healthcare providers
Time Frame: 4 months
Both patients and healthcare providers were instructed to evaluate the Preparation for Decision Making Scale by the Joint Commission of Taiwan. All participants were instructed to respond to 10 questions based on a five-point Likert scale rating (from 1-5). A higher score indicates a greater agreement with the effect.
4 months

Collaborators and Investigators

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

Sponsor

Mackay Medical College

Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Sheng-Miauh Huang, PhD, Department of Nursing

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

Helpful Links

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)

January 1, 2020

Primary Completion (Actual)

August 5, 2021

Study Completion (Actual)

August 5, 2021

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSM/VGH-2019-12-009CC

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

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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