NCT04602910

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

5.9 years

First QC Date

October 15, 2020

Last Update Submit

October 20, 2020

Conditions

Keywords

breast cancershared decision makingwebsiteaction researchfertility preservation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

the phases of planning and acting

EXPERIMENTAL

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

Device: a web-based shared decision-making tool

Interventions

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.

the phases of planning and acting

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health provider who ever cared the patients with breast cancer.
  • Patients with breast cancer who are younger than 50 years old.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tseng LM, Lien PJ, Huang CY, Tsai YF, Chao TC, Huang SM. Developing a Web-Based Shared Decision-Making Tool for Fertility Preservation Among Reproductive-Age Women With Breast Cancer: An Action Research Approach. J Med Internet Res. 2021 Mar 17;23(3):e24926. doi: 10.2196/24926.

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sheng-Miauh Huang, PhD

    Department of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mackay Medical College

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 26, 2020

Study Start

August 1, 2014

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share