Developing and Validating Fertilit-e

NCT03599661 | Terminated Results

• 2 other identifiers: IRB00047585CCCWFU 01717
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Keywords

Cancer; Fertility; Preservation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (1)

• Evaluation of Fertilit-e Alpha- Comprehensibility

  6 months

Study Arms (1)

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; Other: Questionnaire Administration

Interventions

Interview OTHER

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.

Fertilit-e

Questionnaire Administration OTHER

All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.

Fertilit-e

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Stephanie Bunch
• Organization: Wake Forest Baptist Comprehensive Cancer Center

sbunch@wakeforest.edu

336-716-5180

Study Officials

• John Salsman, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 26, 2018
• Study Start: August 15, 2018
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)