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

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.

Completed

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Key information

Conditions

Breast Neoplasm Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a web-based shared decision-making tool

Device

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.

Primary outcomes

Preparation for Decision-Making

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mackay Medical College

Other

Collaborators

Taipei Veterans General Hospital, Taiwan

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Oct 26, 2020
Registry last updated: Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed