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

• Sponsor: Mackay Medical College (Other)
• Overall Status: Completed
• CT.gov ID: NCT05100498
• Collaborator: Taipei Veterans General Hospital, Taiwan (Other)
• Enrollment: 54
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.1
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female; Fertility Preservation	Device: Web-based oncofertility support tool	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Web-based Oncofertility Support Tool for Reproductive-age Women With Breast Cancer
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Aug 5, 2021
• Actual Study Completion Date: Aug 5, 2021

Arms and Interventions

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: Identify the supportive needs of a patient; Guide the development of support interventions; 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nursing	New Taipei City		Taiwan

Sponsors and Collaborators

• Mackay Medical College
• Taipei Veterans General Hospital, Taiwan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Chin-Tsung Shen, Mackay Medical College, Mackay Medical College
• ClinicalTrials.gov Identifier: NCT05100498
• Other Study ID Numbers: HSM/VGH-2019-12-009CC
• First Posted: Oct 29, 2021
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chin-Tsung Shen, Mackay Medical College, Mackay Medical College: breast cancer; fertility preservation; social support; Ottawa Decision Support Framework; website
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Oct 29, 2021