Developing and Validating Fertilit-e

Terminated

• Conditions: Malignant Neoplasm
• Interventions: Other: Interview; Other: Questionnaire Administration

• Registration Number: NCT03599661
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Study Start: 2018-08-15
• Primary Completion: 2022-06-07
• Study Completion: 2023-06-07
• Results First Submitted: 2024-08-19
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Results First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fertilit-e	Questionnaire Administration	Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.
Fertilit-e	Interview	Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.

Primary Outcome Measures

Name	Time	Method
Evaluation of Fertilit-e Alpha - Usability (Number of Participants)	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)	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 Outcome Measures

Name	Time	Method
Evaluation of Fertilit-e Alpha- Comprehensibility	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.

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States