Clinical trial NCT05100498: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Fertility Preservation
Keywords: breast cancer
fertility preservation
social support
Ottawa Decision Support Framework
website
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2021-10-29
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Degree of social support rated before and after using the web-based tool by patients
timeFrame: 4 months
Secondary outcomes:
measure: Preparation for Decision Making (PrepDM) evaluated by patients and healthcare providers
timeFrame: 4 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nursing
Study officials:
affiliation: Department of Nursing
name: Sheng-Miauh Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.