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

Primary Purpose

Infertility, Female, Female Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
web-based decision aid
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility, Female focused on measuring Infertility, young female cancer patients, decision aids, fertility concerns

Eligibility Criteria

20 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cancer and Fertility Decision making

Arm Description

Cancer and Fertility Decision aid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 20, 2018
Last Updated
May 5, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03786458
Brief Title
Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients
Official Title
Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
November 27, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Female Infertility
Keywords
Infertility, young female cancer patients, decision aids, fertility concerns

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cancer and Fertility Decision making
Arm Type
Experimental
Arm Description
Cancer and Fertility Decision aid
Intervention Type
Behavioral
Intervention Name(s)
web-based decision aid
Intervention Description
The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.
Primary Outcome Measure Information:
Title
Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life
Description
Decisional scale
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiu-Yu K Lee, PhD
Phone
886-2-2822-7101
Ext
3316
Email
shiuyu@ntunhs.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Fang Cheng
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Fang Cheng
Email
wenfangcheng@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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