CancerPhase 3NCT05443737
Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients
A Phase 3 study testing Multi-component oncofertility care intervention in people with Cancer and Fertility Preservation, run by University of California, San Diego at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. Read more about this study
- Who is it for?
- Ages 0 to 50 years
- Conditions the study is for
- Cancer, Fertility Preservation
- What is being tested?
- Multi-component oncofertility care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2022to 31 Aug 2027
- Phase
- Phase 3
- 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 0 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed cancer or cancer relapse
- Primary language English or Spanish
- Receiving oncology care at participating clinical sites
- Ages 0 to 42 years if female
- Ages 0 to 50 years if male
Who cannot join
- Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
- Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
City of Hope
Duarte, California, 91010-3000
Saro Armenian, DO, MPH, 626-471-7320, sarmenian@coh.org
Saro Armenian, DO, MPH
- Active, not recruiting
Cancer Resource Center of the Desert
El Centro, California, 92243
- Recruiting
University of California San Diego
La Jolla, California, 92093
H. Irene Su, MD, MSCE, 858-822-5986, hisu@health.ucsd.edu
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Paula Aristizabal, MD, MAS, 858-966-5811, paristizabal@rchsd.org
Paula Aristizabal, MD, MAS
About this study
Official title: Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.
- Conditions
- Cancer, Fertility Preservation
- Being tested
- Multi-component oncofertility care intervention
- Keywords
- Oncofertility, Fertility preservation, Adolescent and young adult cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component oncofertility care interventionBehavioural
The multi-component oncofertility care intervention includes: (1) an adaptive and smart default electronic health record-based oncofertility needs screen and referral pathway, (2) telehealth oncofertility counseling as indicated, and (3) telehealth oncofertility financial navigation as indicated.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component oncofertility care intervention | Experimental | Eligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention. Receives: Behavioral: Multi-component oncofertility care intervention |
| Usual Care | No intervention | Eligible cancer patients presenting to oncology clinical visits will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care
The proportion of eligible reproductive-aged male and female patients (aged 12 to 39 years) who engage in oncofertility services (1| an oncofertility needs screen, 2| referral to oncofertility consult, 3| oncofertility consult, and/or 4| fertility preservation services) that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.
Measured: 12 weeks after oncology visit
Decisional Conflict
The 16-item Decisional Conflict Scale (DCS) will be used to measure patients' decisional conflict for engaging in fertility preservation services. The DCS consists of 16 statements with 5 response options (ranging from strongly agree to strongly disagree) that measures the patient's perceptions of uncertainty in choosing options, feeling informed, values clarity, support in decision making, and effective decision making. The DCS total score will be dichotomized at 37.5 (scale 0-100; > 37.5 indicates high decisional conflict).
Measured: 12 weeks after oncology visit
Secondary outcomes (3)
Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care
The proportion of eligible female and male patients (aged 0 to 42 years for females; 0 to 50 years for males) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.
Measured: 12 weeks after oncology visit
Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care
The proportion of eligible female patients (aged 0 to 42 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.
Measured: 12 weeks after oncology visit
Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care
The proportion of eligible male patients (aged 0 to 50 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.
Measured: 12 weeks after oncology visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jan 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego, City of Hope Medical Center
- Responsible party
- Principal investigator, Hui-Chun Irene Su, University of California, San Diego
- Investigators
- H. Irene Su, MD, MSCE, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443737
- Sponsor's protocol ID
- 800780
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
Publications
Romero SAD, Au L, Flores-Ortega RE, Helsten T, Palomino H, Kaiser BN, Echevarria M, Lukas K, Freeman K, Zou J, Aristizabal P, Armenian S, Su HI. Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors. Contemp Clin Trials. 2024 Jun;141:107537. doi: 10.1016/j.cct.2024.107537. Epub 2024 Apr 13.
PubMed 38614445
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05443737
- Acronym / sponsor ID
- 800780
- Conditions
- Cancer, Fertility Preservation
- Keywords
- Oncofertility, Fertility preservation, Adolescent and young adult cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego, City of Hope Medical Center
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Jul 2022 (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 the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Multi-component oncofertility care intervention | Experimental | Behavioral: Multi-component oncofertility care interventionEligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention. |
| Usual Care | No intervention | –Eligible cancer patients presenting to oncology clinical visits will receive usual care. |
Who may qualify
- Ages
- 0 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Newly diagnosed cancer or cancer relapse
- Primary language English or Spanish
- Receiving oncology care at participating clinical sites
- Ages 0 to 42 years if female
- Ages 0 to 50 years if male
Key exclusion criteria (2 listed)
- Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
- Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis
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 |
|---|---|---|
| Multi-component oncofertility care interventionThe multi-component oncofertility care intervention includes: (1) an adaptive and smart default electronic health record-based oncofertility needs screen and referral pathway, (2) telehealth oncofertility counseling as indicated, and (3) telehealth oncofertility financial navigation as indicated. | Behavioural | Multi-component oncofertility care intervention |
Primary outcome
Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care
Time frame: 12 weeks after oncology visit
The proportion of eligible reproductive-aged male and female patients (aged 12 to 39 years) who engage in oncofertility services (1| an oncofertility needs screen, 2| referral to oncofertility consult, 3| oncofertility consult, and/or 4| fertility preservation services) that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.
Decisional Conflict
Time frame: 12 weeks after oncology visit
The 16-item Decisional Conflict Scale (DCS) will be used to measure patients' decisional conflict for engaging in fertility preservation services. The DCS consists of 16 statements with 5 response options (ranging from strongly agree to strongly disagree) that measures the patient's perceptions of uncertainty in choosing options, feeling informed, values clarity, support in decision making, and effective decision making. The DCS total score will be dichotomized at 37.5 (scale 0-100; > 37.5 indicates high decisional conflict).
3 secondary outcomes
Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care
Time frame: 12 weeks after oncology visit
Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care
Time frame: 12 weeks after oncology visit
Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care
Time frame: 12 weeks after oncology visit
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 3 Dec 2025.
- Derived from this study: PubMed 38614445Romero SAD, Au L, Flores-Ortega RE, Helsten T, Palomino H, Kaiser BN, Echevarria M, Lukas K, Freeman K, Zou J, Aristizabal P, Armenian S, Su HI. Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors. Contemp Clin Trials. 2024 Jun;141:107537. doi: 10.1016/j.cct.2024.107537. Epub 2024 Apr 13.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
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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.
H. Irene Su, MD, MSCE principal investigator
University of California, San Diego
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multi-component oncofertility care intervention in people with Cancer and Fertility Preservation, run by University of California, San Diego at 4 sites 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 2 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact H. Irene Su, MD, MSCE (858-822-5986, hisu@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care (time frame: 12 weeks after oncology visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05443737, which also lists 1 linked publication.
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 3 Dec 2025.