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

Primary Purpose

Breast Neoplasm Female, Fertility Preservation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Web-based oncofertility support tool
Sponsored by
Mackay Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasm Female focused on measuring breast cancer, fertility preservation, social support, Ottawa Decision Support Framework, website

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Web-based oncofertility support tool

Arm Description

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: Identify the supportive needs of a patient; Guide the development of support interventions; Evaluate the quality of web-based oncofertility support.

Outcomes

Primary Outcome Measures

Degree of social support rated before and after using the web-based tool by patients
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 Outcome Measures

Preparation for Decision Making (PrepDM) evaluated by patients and healthcare providers
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.

Full Information

First Posted
October 7, 2021
Last Updated
October 19, 2021
Sponsor
Mackay Medical College
Collaborators
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05100498
Brief Title
Web-based Oncofertility Support Tool for Reproductive-age Women With Breast Cancer
Official Title
Web-based Oncofertility Support Tool for Reproductive-age Women With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 5, 2021 (Actual)
Study Completion Date
August 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Medical College
Collaborators
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Fertility Preservation
Keywords
breast cancer, fertility preservation, social support, Ottawa Decision Support Framework, website

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based oncofertility support tool
Arm Type
Experimental
Arm Description
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: Identify the supportive needs of a patient; Guide the development of support interventions; Evaluate the quality of web-based oncofertility support.
Intervention Type
Device
Intervention Name(s)
Web-based oncofertility support tool
Intervention Description
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 Outcome Measure Information:
Title
Degree of social support rated before and after using the web-based tool by patients
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Preparation for Decision Making (PrepDM) evaluated by patients and healthcare providers
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Miauh Huang, PhD
Organizational Affiliation
Department of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nursing
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35438338
Citation
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.
Results Reference
derived
Links:
URL
https://sites.google.com/mmc.edu.tw/oncofertility/home
Description
Web-based oncofertility support tool for reproductive-age women with breast cancer

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

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