Breast CancerNCT05414812
Intervening on Women's Health for Rural Young Breast Cancer Survivors
A study testing Multi-component oncofertility care intervention in people with Breast Cancer and Fertility, 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 breast 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 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer, Fertility, Contraception
- 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
- 81 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Oct 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Breast cancer (Stages 0-IV) diagnosis
- Primary language English or Spanish
- Receiving oncology care at participating clinical sites
- 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
Pioneers Medical Health District
Brawley, California, 92227
Cancer Resource Center of the Desert
El Centro, California, 92243
El Centro Regional Medical Center
El Centro, California, 92243
University of California San Diego
La Jolla, California, 92093
About this study
The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young breast 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 breast cancer survivors' engagement in goal-concordant oncofertility care.
- Conditions
- Breast Cancer, Fertility, Contraception, Menopausal Symptoms
- Being tested
- Multi-component oncofertility care intervention
- Keywords
- Oncofertility
- Medical subject headings
- Breast 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 intervention includes:
- Young breast cancer patients presenting to oncology visits will complete a clinic-based oncofertility 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.
- A women's health survivorship care plan (SCP) in Spanish and English encompasses content on screening and management strategies for a) fertility concerns/pregnancy health; b) contraception; c) hot flashes and d) sexual health.
- Oncofertility navigation consists of one telehealth or in-person session with a social worker to: i) assess the patient's oncofertility needs, ii) review the women's health SCP, iii) provide support with the goal of engaging in oncofertility care.
- Oncofertility consultation as indicated via telehealth or in person will occur between the patient and reproductive specialist. Each consultation is estimated to be 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component oncofertility care intervention | Experimental | After the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component oncofertility care intervention. Receives: Behavioral: Multi-component oncofertility care intervention |
| Usual Care | No intervention | Prior to the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical record review of engagement in goal-concordant oncofertility care
Study staff will be trained to abstract the primary outcome of engagement in goal-concordant oncofertility care from the patient's medical records using standardized case report forms. Engagement in goal-concordant oncofertility care will be assigned to young breast cancer survivors who undergo: 1) oncofertility needs screen, complete a navigation session, receive the women's health survivorship care plan (SCP), and thereafter have no oncofertility needs; OR 2) oncofertility needs screen, complete a navigation session, receive the SCP, have an oncofertility need, undergo telehealth oncofertility consultation, and thereafter have no oncofertility services needs; OR 3) oncofertility needs screen, complete a navigation session, receive the SCP, have an oncofertility need, undergo telehealth oncofertility consultation, have an oncofertility services need, and thereafter 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 posted10 Jun 2022
- Study start15 Oct 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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 Breast 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Interrupted time series design
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Resource Center of the Desert, El Centro Regional Medical Center, Pioneers Memorial Healthcare District
- 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
- NCT05414812
- Sponsor's protocol ID
- 800646
- Other IDs
- B27BB4247
- Status last verified
- Nov 2024
- First submitted
- 25 May 2022
- Last updated
- 10 Jan 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, Palomino H, Ahmed SH, Peacher D, Urias A, Ramirez L, Yocupicio J, Gutierrez P, Flores Ortega RE, Reyes B, Kaiser BN, Hoyt H, Su HI. Intervening on women's health for rural young breast cancer survivors: A study protocol. Contemp Clin Trials. 2023 Jul;130:107215. doi: 10.1016/j.cct.2023.107215. Epub 2023 May 8.
PubMed 37164298
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening on Women's Health for Rural Young Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05414812
- Acronym / sponsor ID
- 800646
- Conditions
- Breast Cancer, Fertility, Contraception, Menopausal Symptoms
- Keywords
- Oncofertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Cancer Resource Center of the Desert, El Centro Regional Medical Center, Pioneers Memorial Healthcare District
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Jun 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 breast 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 breast cancer survivors' engagement in goal-concordant oncofertility care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interrupted time series design
| Arm | Type | Receives |
|---|---|---|
| Multi-component oncofertility care intervention | Experimental | Behavioral: Multi-component oncofertility care interventionAfter the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component oncofertility care intervention. |
| Usual Care | No intervention | –Prior to the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive usual care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Breast cancer (Stages 0-IV) diagnosis
- Primary language English or Spanish
- Receiving oncology care at participating clinical sites
- 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 oncofertility care interventionThe intervention includes: 1. Young breast cancer patients presenting to oncology visits will complete a clinic-based oncofertility 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. A women's health survivorship care plan (SCP) in Spanish and English encompasses content on screening and management strategies for a) fertility concerns/pregnancy health; b) contraception; c) hot flashes and d) sexual health. 3. Oncofertility navigation consists of one telehealth or in-person session with a social worker to: i) assess the patient's oncofertility needs, ii) review the women's health SCP, iii) provide support with the goal of engaging in oncofertility care. 4. Oncofertility consultation as indicated via telehealth or in person will occur between the patient and reproductive specialist. Each consultation is estimated to be 1 hour. | Behavioural | Multi-component oncofertility care intervention |
Primary outcome
Medical record review of engagement in goal-concordant oncofertility care
Time frame: 12 weeks after oncology visit
Study staff will be trained to abstract the primary outcome of engagement in goal-concordant oncofertility care from the patient's medical records using standardized case report forms. Engagement in goal-concordant oncofertility care will be assigned to young breast cancer survivors who undergo: 1) oncofertility needs screen, complete a navigation session, receive the women's health survivorship care plan (SCP), and thereafter have no oncofertility needs; OR 2) oncofertility needs screen, complete a navigation session, receive the SCP, have an oncofertility need, undergo telehealth oncofertility consultation, and thereafter have no oncofertility services needs; OR 3) oncofertility needs screen, complete a navigation session, receive the SCP, have an oncofertility need, undergo telehealth oncofertility consultation, have an oncofertility services need, and thereafter uptake appropriate services.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 37164298Romero SAD, Palomino H, Ahmed SH, Peacher D, Urias A, Ramirez L, Yocupicio J, Gutierrez P, Flores Ortega RE, Reyes B, Kaiser BN, Hoyt H, Su HI. Intervening on women's health for rural young breast cancer survivors: A study protocol. Contemp Clin Trials. 2023 Jul;130:107215. doi: 10.1016/j.cct.2023.107215. Epub 2023 May 8.
- 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 oncofertility care intervention in people with Breast Cancer and Fertility, 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 10 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medical record review of engagement in goal-concordant oncofertility 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?
On the ClinicalTrials.gov record for NCT05414812, 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 10 Jan 2025.