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

Not Applicable

Completed

• Conditions: Breast Neoplasm Female
• Interventions: Device: a web-based shared decision-making tool

• Registration Number: NCT04602910
• Lead Sponsor: Mackay Medical College

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2020-07
• Study Completion: 2020-08
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Study First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the phases of planning and acting	a web-based shared decision-making tool	Each part of the website page was assessed for comprehensibility and usability by patients. Health care providers were asked to assess the acceptability of the website. A 5-point Likert scale was used for patient and health care provider ratings for each item. If the score were less than 3, then we would modify the website content based on the user feedback from patients and health care providers

Primary Outcome Measures

Name	Time	Method
Preparation for Decision-Making	1 week	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.