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

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ClinicalTrials.gov Identifier: NCT03786458
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infertility, Female Female Infertility Behavioral: web-based decision aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : November 27, 2020
Estimated Study Completion Date : November 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cancer and Fertility Decision making
Cancer and Fertility Decision aid
Behavioral: web-based decision aid
The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.




Primary Outcome Measures :
  1. Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life [ Time Frame: 6 months ]
    Decisional scale



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786458


Contacts
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Contact: Shiu-Yu K Lee, PhD 886-2-2822-7101 ext 3316 shiuyu@ntunhs.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei City, Taipei, Taiwan, 10048
Contact: Wen-Fang Cheng       wenfangcheng@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wen-Fang Cheng National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03786458     History of Changes
Other Study ID Numbers: 201810014RIND
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Infertility
young female cancer patients
decision aids
fertility concerns

Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female