NCT03786458

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

January 11, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

3.6 years

First QC Date

December 20, 2018

Last Update Submit

May 5, 2022

Conditions

Infertility, FemaleFemale Infertility

Keywords

Infertilityyoung female cancer patientsdecision aidsfertility concerns

Outcome Measures

Primary Outcomes (1)

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

    Decisional scale

    6 months

Study Arms (1)

Cancer and Fertility Decision making

EXPERIMENTAL

Cancer and Fertility Decision aid

Behavioral: web-based decision aid

Interventions

web-based decision aidBEHAVIORAL

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

Cancer and Fertility Decision making

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei City, Taipei, 10048, Taiwan

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Wen-Fang Cheng

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiu-Yu K Lee, PhD

CONTACT

886-2-2822-7101shiuyu@ntunhs.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 26, 2018

Study Start

January 11, 2019

Primary Completion

August 31, 2022

Study Completion

November 27, 2022

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

TW(1)