NCT06199726

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 11, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2026

Expected
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

December 28, 2023

Last Update Submit

February 5, 2026

Conditions

Reproductive Behavior

Keywords

Fertility

Outcome Measures

Primary Outcomes (5)

  • Ease of use of the REFLECT tool

    System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)

    One Year

  • Confidence in use of the REFLECT tool

    System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)

    One Year

  • Complexity of use of the REFLECT tool

    System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)

    One Year

  • Desire to use the REFLECT tool

    System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)

    One Year

  • Perception of inconsistencies of the REFLECT tool

    System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)

    One Year

Study Arms (2)

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

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

Interventions

REFLECT web-based toolBEHAVIORAL

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 1 Interviews and/or Focus GroupRound 2 Interviews and/or Focus Group

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Reproductive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Susan Vadaparampil

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

December 11, 2023

Primary Completion

December 5, 2025

Study Completion (Estimated)

December 5, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(1)