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Clinical Trials/NCT03599661
NCT03599661
Terminated
N/A

Developing and Validating Fertilit-e: An eHealth Fertility Preservation Decision Aid for Young Adults With Cancer - Aim 1

Wake Forest University Health Sciences1 site in 1 country21 target enrollmentAugust 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malignant Neoplasm
Sponsor
Wake Forest University Health Sciences
Enrollment
21
Locations
1
Primary Endpoint
Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Status
Terminated
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2018
End Date
June 7, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of cancer during ages 15 to
  • 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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Evaluation of Fertilit-e Alpha- Comprehensibility(6 months)

Study Sites (1)

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