Clinical trial NCT03599661: Developing and Validating Fertilit-e
Official title: Developing and Validating Fertilit-e: An eHealth Fertility Preservation Decision Aid for Young Adults With Cancer - Aim 1
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Neoplasm
Keywords: Cancer
Fertility
Preservation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults with cancer who are currently ages 18 to 39.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
timeFrame: 6 months
measure: Evaluation of Fertilit-e Alpha- Usability (System Usability Scale)
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of Fertilit-e Alpha- Comprehensibility
timeFrame: 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: John Salsman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: