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

NCT ID: NCT03786458

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2022-11-27

Brief Summary

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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

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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.

Conditions

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Infertility, Female Female Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cancer and Fertility Decision making

Cancer and Fertility Decision aid

Group Type EXPERIMENTAL

web-based decision aid

Intervention Type BEHAVIORAL

The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.

Interventions

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web-based decision aid

The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen-Fang Cheng

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei City, Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shiu-Yu K Lee, PhD

Role: CONTACT

886-2-2822-7101 ext. 3316

Facility Contacts

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Wen-Fang Cheng

Role: primary

Other Identifiers

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201810014RIND

Identifier Type: -

Identifier Source: org_study_id

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