CancerNCT06664034
Intervening on Women's Health for Rural Young Cancer Survivors
A study testing Multi-component reproductive health care intervention in people with Cancer and Fertility Issues, run by University of California, San Diego at 4 sites in United States.
Trial summary
The purpose of this pilot study is to evaluate the feasibility of a multi-component intervention to improve young female cancer survivors' engagement in goal-concordant reproductive health care. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Cancer, Fertility Issues, Contraception
- What is being tested?
- Multi-component reproductive health care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Dec 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cancer (Stages 0-IV) diagnosis
- Primary language English or Spanish
- Receiving oncology care at rural oncology clinical participating site
- Living in Imperial County, California
Who cannot join
- Women who are pregnant at recruitment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
San Diego State University - Imperial Valley/ School of Nursing
Brawley, California, 92227
Cancer Resource Center of the Desert
El Centro, California, 92243
El Centro Regional Medical Center
El Centro, California, 92243
University of Califiornia San Diego
La Jolla, California, 92093
About this study
The purpose of this pilot study is to evaluate the feasibility of a multi-component intervention to improve young female cancer survivors' engagement in goal-concordant reproductive health care. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant reproductive health care.
- Conditions
- Cancer, Fertility Issues, Contraception
- Being tested
- Multi-component reproductive health care intervention
- Keywords
- Reproductive health, Oncofertility
- Medical subject headings
- Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component reproductive health care interventionBehavioural
The multi-component reproductive health care intervention includes:
- Young cancer patients presenting to oncology visits will complete a clinic-based reproductive health needs screen with a member of the clinical team. This needs screen assesses i) desire to have a child in the future, ii) need for contraception, and iii) sexual health/menopause symptoms.
- Reproductive health patient navigation consists of one telehealth or in-person session with a social worker to: i) assess the patient's reproductive health needs, ii) provide individualized patient education and counseling on a) infertility risk related to cancer type and treatment and b) screening and management strategies for reproductive health needs, iii) provide support with the goal of engaging in goal-concordant reproductive health care.
- Telehealth reproductive health consultation will occur between the patient and reproductive specialist. Each consultation is estimated to be 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component intervention | Experimental | Female cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component intervention. Receives: Behavioral: Multi-component reproductive health care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patient's Engagement in Goal-concordant Reproductive Health Care
Study staff will be trained to abstract the primary outcome from the patient's medical records using standardized case report forms. Engagement in goal-concordant reproductive health care will be assigned to patients who undergo: 1) reproductive health needs screen and have no needs, OR 2) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, and have no further needs; OR 3) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, have a need, undergo a telehealth reproductive health consultation, and have no reproductive health service needs; OR 4) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, have a need, undergo a telehealth reproductive health consultation, have a reproductive health service needs, and uptake appropriate services.
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 posted29 Oct 2024
- Study start1 Dec 2024
- Primary completion30 Sep 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm pilot hybrid type I trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University, Cancer Resource Center of the Desert, El Centro Regional Medical Center, National Cancer Institute (NCI)
- 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
- NCT06664034
- Sponsor's protocol ID
- U54800646
- Other IDs
- 5U54CA285115-02
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2024
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening on Women's Health for Rural Young Cancer Survivors
- ClinicalTrials.gov ID
- NCT06664034
- Acronym / sponsor ID
- U54800646
- Conditions
- Cancer, Fertility Issues, Contraception
- Keywords
- Reproductive health, Oncofertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- San Diego State University, Cancer Resource Center of the Desert, El Centro Regional Medical Center, National Cancer Institute (NCI)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Posted 3 Nov 2026
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 pilot study is to evaluate the feasibility of a multi-component intervention to improve young female cancer survivors' engagement in goal-concordant reproductive health care. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant reproductive health care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm pilot hybrid type I trial
| Arm | Type | Receives |
|---|---|---|
| Multi-component intervention | Experimental | Behavioral: Multi-component reproductive health care interventionFemale cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component intervention. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Cancer (Stages 0-IV) diagnosis
- Primary language English or Spanish
- Receiving oncology care at rural oncology clinical participating site
- Living in Imperial County, California
Key exclusion criteria (1 listed)
- Women who are pregnant at recruitment
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 reproductive health care interventionThe multi-component reproductive health care intervention includes: 1. Young cancer patients presenting to oncology visits will complete a clinic-based reproductive health needs screen with a member of the clinical team. This needs screen assesses i) desire to have a child in the future, ii) need for contraception, and iii) sexual health/menopause symptoms. 2. Reproductive health patient navigation consists of one telehealth or in-person session with a social worker to: i) assess the patient's reproductive health needs, ii) provide individualized patient education and counseling on a) infertility risk related to cancer type and treatment and b) screening and management strategies for reproductive health needs, iii) provide support with the goal of engaging in goal-concordant reproductive health care. 3. Telehealth reproductive health consultation will occur between the patient and reproductive specialist. Each consultation is estimated to be 1 hour. | Behavioural | Multi-component intervention |
Primary outcome
Proportion of Patient's Engagement in Goal-concordant Reproductive Health Care
Time frame: 12 weeks after oncology visit
Study staff will be trained to abstract the primary outcome from the patient's medical records using standardized case report forms. Engagement in goal-concordant reproductive health care will be assigned to patients who undergo: 1) reproductive health needs screen and have no needs, OR 2) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, and have no further needs; OR 3) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, have a need, undergo a telehealth reproductive health consultation, and have no reproductive health service needs; OR 4) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, have a need, undergo a telehealth reproductive health consultation, have a reproductive health service needs, and uptake appropriate services.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
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 study testing Multi-component reproductive health care intervention in people with Cancer and Fertility Issues, 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 4 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: finished, as of the sponsor's last update on 3 Nov 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patient's Engagement in Goal-concordant Reproductive Health Care (time frame: 12 weeks after oncology visit). 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 3 Nov 2026.