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

Not Applicable

• Conditions: Infertility, Female; Female Infertility
• Interventions: Behavioral: web-based decision aid

• Registration Number: NCT03786458
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-26
• Study Start: 2019-01-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09
• Primary Completion: 2022-08-31
• Study Completion: 2022-11-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 115

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cancer and Fertility Decision making	web-based decision aid	Cancer and Fertility Decision aid

Primary Outcome Measures

Name	Time	Method
Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life	6 months	Decisional scale

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taipei, Taiwan