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| ID | Type | Description | Link |
|---|---|---|---|
| B27BB4247 | Other Grant/Funding Number | California Breast Cancer Research Program |
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| Name | Class |
|---|---|
| Cancer Resource Center of the Desert | UNKNOWN |
| El Centro Regional Medical Center | UNKNOWN |
| Pioneers Memorial Healthcare District | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-component oncofertility care intervention | Behavioral | The intervention includes:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after oncology visit |
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Inclusion Criteria:
Exclusion Criteria:
- Women who are pregnant at recruitment
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| Name | Affiliation | Role |
|---|---|---|
| H. Irene Su, MD, MSCE | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pioneers Medical Health District | Brawley | California | 92227 | United States | ||
| Cancer Resource Center of the Desert |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37164298 | Derived | 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. |
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Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to the principal investigator (H. Irene Su).
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Interrupted time series design
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|
| El Centro |
| California |
| 92243 |
| United States |
| El Centro Regional Medical Center | El Centro | California | 92243 | United States |
| University of California San Diego | La Jolla | California | 92093 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |