NCT05100498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

October 7, 2021

Last Update Submit

October 19, 2021

Conditions

Breast Neoplasm FemaleFertility Preservation

Keywords

breast cancerfertility preservationsocial supportOttawa Decision Support Frameworkwebsite

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Secondary Outcomes (1)

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

    4 months

Study Arms (1)

Web-based oncofertility support tool

EXPERIMENTAL

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

Interventions

Web-based oncofertility support toolDEVICE

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.

Web-based oncofertility support tool

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35438338DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sheng-Miauh Huang, PhD

    Department of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mackay Medical College

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 29, 2021

Study Start

January 1, 2020

Primary Completion

August 5, 2021

Study Completion

August 5, 2021

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)