- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06199726
REFLECT: Reproductive Education and Fertility Links for Cancer Treatment (REFLECT)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults between the ages of 18-39
- Must have received Cancer care at Moffitt Cancer Center
- Participants must consider having a child in the future or have had children at the time of diagnosis
- Participants must be able to speak and read English
- Participants must have access to a device that can connect to the internet
Exclusion Criteria:
- Any participants who do not meet all Inclusion Criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Round 1 Interviews and/or Focus Group
Approximately12 people will be recruited complete interviews or focus groups in Round 1. The participants will be provided with the REFLECT tool. There will be interviews and discussions via telephone or ZOOM and feedback will be obtained to enhance the REFLECT tool. |
Partnering with Nest Genomics, Investigators have developed a customizable web-based tool to support AYA patients through their cancer diagnosis journey for topics related to future family building and genetics.
This interactive tool will include educational content to organize knowledge, make connections between concepts, and will include web links to more in-depth content and embedded videos.
The interface will allow users to document questions that would be helpful in provider discussions and include decision support to assist with determining values and needs for proceeding with consultations related to genetic counseling and testing, and fertility.
|
|
Round 2 Interviews and/or Focus Group
Approximately 13 people will be recruited to complete interviews or focus group in Round 2. The participants will be provided with the REFLECT tool that has been modified to include feedback from Round 1 interviews/focus groups. There will be interviews and discussions via telephone or ZOOM and feedback will be obtained on the enhanced tool. |
Partnering with Nest Genomics, Investigators have developed a customizable web-based tool to support AYA patients through their cancer diagnosis journey for topics related to future family building and genetics.
This interactive tool will include educational content to organize knowledge, make connections between concepts, and will include web links to more in-depth content and embedded videos.
The interface will allow users to document questions that would be helpful in provider discussions and include decision support to assist with determining values and needs for proceeding with consultations related to genetic counseling and testing, and fertility.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ease of use of the REFLECT tool
Time Frame: One Year
|
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
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One Year
|
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Confidence in use of the REFLECT tool
Time Frame: One Year
|
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
|
One Year
|
|
Complexity of use of the REFLECT tool
Time Frame: One Year
|
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
|
One Year
|
|
Desire to use the REFLECT tool
Time Frame: One Year
|
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
|
One Year
|
|
Perception of inconsistencies of the REFLECT tool
Time Frame: One Year
|
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
|
One Year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susan Vadaparampil, Moffitt Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-22569
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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