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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786458
• Other study ID #: 201810014RIND
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: November 27, 2022

Study information

• Verified date: May 2022
• Source: National Taiwan University Hospital
• Contact: Shiu-Yu K Lee, PhD
• Phone: 886-2-2822-7101
• Email: shiuyu[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: November 27, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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 45.

• 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.

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Behavioral:
• web-based decision aid
The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life	Decisional scale	6 months