Developing and Validating Fertilit-e

November 20, 2024 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Young adults with cancer who are currently ages 18 to 39.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Interview
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.
Other: Questionnaire Administration
All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Fertilit-e Alpha- Comprehensibility
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: John Salsman, Ph.D., Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

June 7, 2022

Study Completion (Actual)

June 7, 2023

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00047585
  • CCCWFU 01717 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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