Malignant Neoplasm
Conditions
Keywords
Cancer, Fertility, Preservation
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.
Interventions
OTHERInterview
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.
OTHERQuestionnaire 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.
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | Fertilit-e |
|---|---|
| Age, Continuous | 30.0 years STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 6 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Homepage | Usable | 4 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Homepage | Not usable | 8 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Risks/Options | Usable | 6 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Risks/Options | Not usable | 6 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Personal Stories | Usable | 9 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Personal Stories | Not usable | 3 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Financial Concerns | Usable | 8 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Financial Concerns | Not usable | 4 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | FAQ | Usable | 9 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | FAQ | Not usable | 3 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Personal Summary | Usable | 5 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha - Usability (Number of Participants) | Personal Summary | Not usable | 7 Participants |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fertilit-e | Evaluation of Fertilit-e Alpha- Usability (System Usability Scale) | 85.0 score on a scale | Standard Deviation 15.5 |
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.
Time frame: 6 months
Population: All 12 participants for Personal Stories, FAQ, and Personal Summary did not provide data for these themes.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Financial Concerns | Not comprehensible | 8 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Homepage | Comprehensible | 8 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Homepage | Not comprehensible | 4 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Risks/Options | Comprehensible | 9 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Risks/Options | Not comprehensible | 3 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Personal Stories | Comprehensible | 5 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Personal Stories | Not comprehensible | 1 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Financial Concerns | Comprehensible | 4 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | FAQ | Comprehensible | 5 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | FAQ | Not comprehensible | 1 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Personal Summary | Comprehensible | 0 Participants |
| Fertilit-e | Evaluation of Fertilit-e Alpha- Comprehensibility | Personal Summary | Not comprehensible | 0 Participants |