Skip to main content
OpenTrials
Completed

NCT Number: NCT05100498

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasm Female Breast Diseases Breast Neoplasms Fertility Preservation Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nursing

New Taipei City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Web-based oncofertility support tool

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mackay Medical College

Other

Collaborators

  • Taipei Veterans General Hospital, Taiwan

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2021
Registry last updated
Oct 29, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.