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Clinical Trials/NCT03786458
NCT03786458
Unknown
N/A

Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients

National Taiwan University Hospital1 site in 1 country115 target enrollmentJanuary 11, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infertility, Female
Sponsor
National Taiwan University Hospital
Enrollment
115
Locations
1
Primary Endpoint
Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life
Last Updated
3 years ago

Overview

Brief Summary

This study aims to develop a patient-centered, user-center, interactive web-based decision aid to support the young women with cancer in making an informed fertility-related decision and further evaluate its efficacy.

Detailed Description

This study uses mixed-method and involves 2 stages. As following the IPDAS recommendation for developing decision aids, the first sample of 25 young woman survivors with breast, hematology or ovarian cancer, and oncologist, fertility specialists or nurses will be interviewed to assess the fertility-related decision needs from and. The decision aid is then developed further process of evidence synthesis and multidisciplinary external review. After the draft being evaluated for its validity via Think-aloud cognitive interview method, field testing via one-group quasi-experimental design on 90 young women with newly diagnosed breast, hematology or ovarian cancer will be applied to test its outcomes of decision quality, emotional health and fertility concerns.

Registry
clinicaltrials.gov
Start Date
January 11, 2019
End Date
November 27, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age between 20 to 44
  • Have been diagnosed with breast, hematology or ovarian cancer, and will conduct cancer treatment, such as chemotherapy, hormonal or radiation.
  • Willing to take questionnaire via computer and tablet.
  • Ability to answer the questionnaire with functional emotion and cognition.
  • Ability to read newspaper.
  • Had been consulted and advised by Doctor on the ability of fertility, but have not decided to give birth to a baby.

Exclusion Criteria

  • Age below 20 or above
  • Had been diagnosed with stage 4 cancer.
  • Do not require chemotherapy, hormonal or radiation therapy.
  • Not able to read newspaper or do not access the internet.

Outcomes

Primary Outcomes

Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life

Time Frame: 6 months

Decisional scale

Study Sites (1)

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