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NCT04602910 Clinical Trial

Developing a Web-based Shared Decision-making Tool for Fertility Preservation

Breast Neoplasm Female Clinical Trial

Official title:
Developing a Web-based Shared Decision-making Tool for Fertility Preservation Among Reproductive-age Women With Breast Cancer: An Action Research Approach

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04602910
Other study ID # HSM/VGH-V108E-005-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date August 2020

Study information
Verified date October 2020
Source Mackay Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was to develop a web-based, shared decision-making (SDM) tool for helping patients with breast cancer make decisions on fertility preservation.

Description:

Background: The pregnancy rate after cancer treatment for female survivors is lower than that of the general population. Future infertility is a significant concern for patients with breast cancer and is associated with a poor quality of life. Reproductive- age patients with breast cancer have safe options when choosing the type of fertility preservation method to be applied. Better information and support resources aimed at women to support their decision making are needed. Objective: The objective of this study was to develop a web-based, shared decision-making (SDM) tool for helping patients with breast cancer make decisions on fertility preservation. Methods: We used the action research cycle of observing, reflecting, planning, and acting to develop a web-based SDM tool. The following four phrases were applied: (1) Observe and reflect: Collect and analyze the decision-making experiences of patients and health care providers; (2) Reflect and plan: Apply the initial results to create a paper design and modify the content; (3) Plan and act: Brainstorm about the web pages, and modify the content; (4) Act and observe: Evaluate the effectiveness, and refine the website SDM. Interviews, group meetings, and constant dialogue were conducted between the various participants at each step. The effectiveness was evaluated using the Preparation for Decision-Making (prepDM) scale.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date August 2020
Est. primary completion date July 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 65 Years
Eligibility Inclusion Criteria: - Health provider who ever cared the patients with breast cancer. - Patients with breast cancer who are younger than 50 years old. Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• a web-based shared decision-making tool
Five major parts were developed with the use of the action research approach. The Introduction and Options (parts 1 and 2) describe the severity of the cancer treatment and infertility and the knowledge of fertility preservation, respectively. The SDM tool was designed as a step by step process (part 3) that involves the comparison of options, patient's values and preferences, their knowledge regarding infertility and options, and reaching a collective decision. The Resources (part 4) provide information on the hospitals that provide such services, and the References (part 5) list all the literature cited in the website. The results show the web-based SDM meets both the patients' and health providers' needs and helps reproductive-age patients with breast cancer make decisions on fertility preservation.

Locations
Country Name City State
n/a

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

Outcome
Type Measure Description Time frame Safety issue
Primary Preparation for Decision-Making We evaluated the effectiveness of the Preparation for Decision-Making (prepDM) scale. Both patients and health care providers were invited to answer 10 questions by responding with a 5-point Likert scale rating (from 1 to 5). A higher score indicated greater agree with the effect. 1 week
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