REFLECT: Reproductive Education and Fertility Links for Cancer Treatment (REFLECT)

December 28, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute
The purpose of this study is to evaluate a web-based education tool geared at helping Adolescent and Young Adult (AYA) patients better understand fertility and genetic risks for cancer in future offspring.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Susan Vadaparampil, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults ages 18-39 who have received cancer care at Moffitt and have children or are considering having a chilid in the future.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: REFLECT web-based 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.
Behavioral: REFLECT web-based 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)
One Year
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

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Susan Vadaparampil, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCC-22569

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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