Reproductive BehaviorREFLECTNCT06199726
REFLECT: Reproductive Education and Fertility Links for Cancer Treatment
An observational study of Reproductive Behavior, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Reproductive Behavior
- What is being tested?
- REFLECT web-based tool
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to 5 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Any participants who do not meet all Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Reproductive Behavior
- Being tested
- REFLECT web-based tool
- Keywords
- Fertility
- Medical subject headings
- Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REFLECT web-based toolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: REFLECT web-based tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use of the REFLECT tool
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Measured: One Year
Confidence in use of the REFLECT tool
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Measured: One Year
Complexity of use of the REFLECT tool
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Measured: One Year
Desire to use the REFLECT tool
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Measured: One Year
Perception of inconsistencies of the REFLECT tool
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start11 Dec 2023
- Primary completion5 Dec 2025
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive BehaviorStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Vadaparampil, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199726
- Sponsor's protocol ID
- MCC-22569
- Acronym
- REFLECT
- Status last verified
- May 2026
- First submitted
- 28 Dec 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFLECT: Reproductive Education and Fertility Links for Cancer Treatment
- ClinicalTrials.gov ID
- NCT06199726
- Acronym / sponsor ID
- REFLECT / MCC-22569
- Conditions
- Reproductive Behavior
- Keywords
- Fertility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Round 1 Interviews and/or Focus Group | – | Behavioral: REFLECT web-based toolApproximately12 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. |
| Round 2 Interviews and/or Focus Group | – | Behavioral: REFLECT web-based toolApproximately 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Any participants who do not meet all Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REFLECT web-based toolPartnering 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. | Behavioural | Round 1 Interviews and/or Focus Group, Round 2 Interviews and/or Focus Group |
Primary outcome
Ease of use of the REFLECT tool
Time frame: One Year
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Confidence in use of the REFLECT tool
Time frame: One Year
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Complexity of use of the REFLECT tool
Time frame: One Year
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Desire to use the REFLECT tool
Time frame: One Year
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Perception of inconsistencies of the REFLECT tool
Time frame: One Year
System usability scale of 1-5 (1 strongly disagree and 5 strongly agree)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Vadaparampil principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Behavior, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use of the REFLECT tool (time frame: One Year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.