Developing and Validating Fertilit-e

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03599661
• Other study ID #: IRB00047585
• Secondary ID: CCCWFU 01717
• Status: Terminated
• Start date: August 15, 2018
• Est. completion date: June 7, 2023

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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).

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Fertilit-e alpha- Usability	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.	up to 1 year
Primary	Evaluation of Fertilit-e alpha- Usability	To evaluate Fertilit-e alpha, we will examine its usability through the System Usability Scale. The score range is 0 to 100. Higher scores are better and scores above 68 are considered above average.	up to 1 year
Secondary	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.	up to 1 year