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

NCT ID: NCT05100498

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-08-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Neoplasm Female Fertility Preservation

Keywords

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breast cancer fertility preservation social support Ottawa Decision Support Framework website

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Web-based oncofertility support tool

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

Mackay Medical College

OTHER

Sponsor Role lead

Responsible Party

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Chin-Tsung Shen

Mackay Medical College

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheng-Miauh Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing

Locations

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Department of Nursing

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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Huang SM, Tseng LM, Yang MJ, Chang A, Lien PJ, Hsiung Y. Developing a web-based oncofertility tool for reproductive-age women with breast cancer based on social support framework. Support Care Cancer. 2022 Jul;30(7):6195-6204. doi: 10.1007/s00520-022-07046-x. Epub 2022 Apr 19.

Reference Type DERIVED
PMID: 35438338 (View on PubMed)

Related Links

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https://sites.google.com/mmc.edu.tw/oncofertility/home

Web-based oncofertility support tool for reproductive-age women with breast cancer

Other Identifiers

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HSM/VGH-2019-12-009CC

Identifier Type: -

Identifier Source: org_study_id