Infertility, FemaleNCT03786458
Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients
A study testing web-based decision aid in people with Infertility, Female and Female Infertility, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- Infertility, Female, Female Infertility
- What is being tested?
- web-based decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2019to 27 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei City, Taipei, 10048
Wen-Fang Cheng, wenfangcheng@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Infertility, Female, Female Infertility
- Being tested
- web-based decision aid
- Keywords
- Infertility, young female cancer patients, decision aids, fertility concerns
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based decision aidBehavioural
The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.
| Study group | Role | What they receive |
|---|---|---|
| Cancer and Fertility Decision making | Experimental | Cancer and Fertility Decision aid Receives: Behavioral: web-based decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life
Decisional scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start11 Jan 2019
- Primary completion31 Aug 2022 (estimated)
- Study completion27 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Fang Cheng, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786458
- Sponsor's protocol ID
- 201810014RIND
- Status last verified
- May 2022
- First submitted
- 20 Dec 2018
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients
- ClinicalTrials.gov ID
- NCT03786458
- Acronym / sponsor ID
- 201810014RIND
- Conditions
- Infertility, Female, Female Infertility
- Keywords
- Infertility, young female cancer patients, decision aids, fertility concerns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 27 Nov 2022 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer and Fertility Decision making | Experimental | Behavioral: web-based decision aidCancer and Fertility Decision aid |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based decision aidThe decision aid is then developed further process of evidence synthesis and multidisciplinary external review. | Behavioural | Cancer and Fertility Decision making |
Primary outcome
Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life
Time frame: 6 months
Decisional scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Fang Cheng principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based decision aid in people with Infertility, Female and Female Infertility, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiu-Yu K Lee, PhD (886-2-2822-7101 ext. 3316, shiuyu@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.