Clinical Trials Logo
  1. Home
  2. Breast Neoplasm Female
  3. NCT05100498
  4. Details
NCT05100498 Clinical Trial

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

Breast Neoplasm Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05100498
Other study ID # HSM/VGH-2019-12-009CC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date August 5, 2021

Study information
Verified date October 2021
Source Mackay Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date August 5, 2021
Est. primary completion date August 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Taiwan Department of Nursing New Taipei City

Sponsors (2)
Lead Sponsor Collaborator
Mackay Medical College Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. 4 months
See also
  Status Clinical Trial Phase
Completed NCT03980626 - Study on Physical Activity's Relationship With Cancer and Cognition N/A
Completed NCT04329819 - Satisfaction and QUality of Life After Breast REconstruction
Recruiting NCT03323346 - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer Phase 2
Active, not recruiting NCT03900884 - Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer Phase 1
Completed NCT05042999 - The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures N/A
Not yet recruiting NCT03662633 - Diagnosis Value of SEMA4C in Breast Cancer
Recruiting NCT05075512 - The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer Phase 2
Recruiting NCT04456855 - Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
Not yet recruiting NCT03629509 - BEFORE Decision Aid Implementation Study N/A
Completed NCT04811378 - HaemoCerTM Application in Breast Cancer Surgery N/A
Completed NCT03198442 - Breast PET Feasibility N/A
Not yet recruiting NCT05577442 - Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer Phase 2
Enrolling by invitation NCT04047823 - Temperature and Injury in Radiotherapy Radiation Skin Injury
Recruiting NCT05452213 - Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients Phase 4
Recruiting NCT05027321 - Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies N/A
Active, not recruiting NCT04812652 - Digitally Distributed Yoga for Women Treated for Breast Cancer N/A
Active, not recruiting NCT03425838 - Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer Phase 3
Completed NCT05473026 - Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors N/A
Completed NCT04509063 - Investigating Public Enthusiasm for Mammography Screening in Denmark N/A
Recruiting NCT05711030 - Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery N/A

External Links