Malignant NeoplasmNCT03599661
Developing and Validating Fertilit-e
An observational study of Malignant Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The main purpose of this project is to adapt and validate an eHealth fertility preservation decision-making support tool (Fertilit-e) for young adults with cancer. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Interview and Questionnaire Administration
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 7 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adults with cancer who are currently ages 18 to 39.
Who may be able to join
- Histologically confirmed diagnosis of cancer during ages 15 to 39.
- Will be receiving or have received treatment associated with a risk of infertility (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic surgery with potential impact on reproductive function).
- Considered or wish they had considered fertility preservation treatments.
- Able to speak, read, and understand English.
- Able to provide informed consent.
- Have internet access.
- Have a laptop or desktop computer that can connect to WebEx.
Who cannot join
- Infertility diagnosis prior to cancer diagnosis.
- History of fertility preservation or fertility treatments prior to their cancer diagnosis.
- Are more than five years post-cancer-related treatments (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic surgery).
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Developing and Validating Fertilit-e: An eHealth Fertility Preservation Decision Aid for Young Adults With Cancer - Aim 1
The main purpose of this project is to adapt and validate an eHealth fertility preservation decision-making support tool (Fertilit-e) for young adults with cancer.
Read the detailed description
The overarching goal is to utilize innovations in eHealth technology to address fertility preservation knowledge deficits and decision-making options for young adults with cancer ages 18-39 years of age. Every year, approximately 70,000 young adults (ages 18-39) are diagnosed with cancer, which can significantly affect their health-related quality of life in multiple areas, including the potential for infertility or other reproductive challenges. Despite this, very few young adults diagnosed with cancer are actually provided fertility preservation information let alone effective strategies or tools for how to best navigate their fertility preservation options. It is critical to provide decision-making information and support about infertility risk and existing interventions to maintain reproductive potential in a delivery mode that is most congruent with this population's health communication style, such as eHealth applications.
The goal is to adapt and optimize fertility preservation content in a tailored mHealth tool for fertility preservation decision-making. More specifically, the team will adapt fertility-preservation content for tailored, rapid, and clear dissemination of information in an engaging, cross-platform, patient-friendly mHealth format. The study team will alpha-test this tool with an ethnically diverse sample of cross-cultural end users to collect qualitative data and evaluate usability and comprehensibility to refine content and design. No formal hypothesis testing will be done.
- Conditions
- Malignant Neoplasm
- Being tested
- Interview, Questionnaire Administration
- Keywords
- Cancer, Fertility, Preservation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.
Questionnaire AdministrationOther
All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.
| Study group | Role | What they receive |
|---|---|---|
| Fertilit-e | Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes. Receives: Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
To evaluate Fertilit-e alpha, we will examine its usability through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.
Measured: 6 months
Evaluation of Fertilit-e Alpha- Usability (System Usability Scale)
To evaluate Fertilit-e alpha, we will examine its usability through the System Usability Scale, a simple, ten-item attitude Likert scale (1 - strongly disagree to 5 strongly agree) giving a global view of subjective assessments of usability. The score range is 0 to 100. Higher scores are better and scores above 68 are considered above average.
Measured: 6 months
Secondary outcomes (1)
Evaluation of Fertilit-e Alpha- Comprehensibility
To evaluate Fertilit-e alpha, we will examine its comprehensibility and design through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.
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 Jul 2018
- Study start15 Aug 2018
- Primary completion7 Jun 2022
- Study completion7 Jun 2023
Why it stopped: PI decision - competing study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Salsman, Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599661
- Sponsor's protocol ID
- IRB00047585
- Other IDs
- CCCWFU 01717
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2018
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Validating Fertilit-e: An eHealth Fertility Preservation Decision Aid for Young Adults With Cancer - Aim 1
- ClinicalTrials.gov ID
- NCT03599661
- Acronym / sponsor ID
- IRB00047585
- Conditions
- Malignant Neoplasm
- Keywords
- Cancer, Fertility, Preservation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI decision - competing study
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this project is to adapt and validate an eHealth fertility preservation decision-making support tool (Fertilit-e) for young adults with cancer.
Detailed description
The overarching goal is to utilize innovations in eHealth technology to address fertility preservation knowledge deficits and decision-making options for young adults with cancer ages 18-39 years of age. Every year, approximately 70,000 young adults (ages 18-39) are diagnosed with cancer, which can significantly affect their health-related quality of life in multiple areas, including the potential for infertility or other reproductive challenges. Despite this, very few young adults diagnosed with cancer are actually provided fertility preservation information let alone effective strategies or tools for how to best navigate their fertility preservation options. It is critical to provide decision-making information and support about infertility risk and existing interventions to maintain reproductive potential in a delivery mode that is most congruent with this population's health communication style, such as eHealth applications.
The goal is to adapt and optimize fertility preservation content in a tailored mHealth tool for fertility preservation decision-making. More specifically, the team will adapt fertility-preservation content for tailored, rapid, and clear dissemination of information in an engaging, cross-platform, patient-friendly mHealth format. The study team will alpha-test this tool with an ethnically diverse sample of cross-cultural end users to collect qualitative data and evaluate usability and comprehensibility to refine content and design. No formal hypothesis testing will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fertilit-e | – | Other: Interview, Other: Questionnaire AdministrationParticipants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adults with cancer who are currently ages 18 to 39.
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of cancer during ages 15 to 39.
- Will be receiving or have received treatment associated with a risk of infertility (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic surgery with potential impact on reproductive function).
- Considered or wish they had considered fertility preservation treatments.
- Able to speak, read, and understand English.
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- Infertility diagnosis prior to cancer diagnosis.
- History of fertility preservation or fertility treatments prior to their cancer diagnosis.
- Are more than five years post-cancer-related treatments (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic surgery).
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 |
|---|---|---|
| InterviewParticipants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes. | Other | Fertilit-e |
| Questionnaire AdministrationAll participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition. | Other | Fertilit-e |
Primary outcome
Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Time frame: 6 months
To evaluate Fertilit-e alpha, we will examine its usability through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.
Evaluation of Fertilit-e Alpha- Usability (System Usability Scale)
Time frame: 6 months
To evaluate Fertilit-e alpha, we will examine its usability through the System Usability Scale, a simple, ten-item attitude Likert scale (1 - strongly disagree to 5 strongly agree) giving a global view of subjective assessments of usability. The score range is 0 to 100. Higher scores are better and scores above 68 are considered above average.
1 secondary outcome
Evaluation of Fertilit-e Alpha- Comprehensibility
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John Salsman, Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Jan 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Fertilit-e Alpha - Usability (Number of Participants) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 Jan 2025.