Intervening on Women's Health for Rural Young Cancer Survivors
2 other identifiers
interventional
64
1 country
4
Brief 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. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant reproductive health care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Dec 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
September 4, 2025
August 1, 2025
1.5 years
October 27, 2024
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks after oncology visit
Study Arms (1)
Multi-component intervention
EXPERIMENTALAfter the intervention implementation, all cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component intervention.
Interventions
The 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 and ii) need for contraception. 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.
Eligibility Criteria
You may qualify if:
- Cancer (Stages 0-IV) diagnosis
- Primary language English or Spanish
- Receiving oncology care at rural oncology clinical participating site
- Living in Imperial County, California
You may not qualify if:
- \- Women who are pregnant at recruitment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- San Diego State Universitycollaborator
- Cancer Resource Center of the Desertcollaborator
- El Centro Regional Medical Centercollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (4)
San Diego State University - Imperial Valley/ School of Nursing
Brawley, California, 92227, United States
Cancer Resource Center of the Desert
El Centro, California, 92243, United States
El Centro Regional Medical Center
El Centro, California, 92243, United States
University of Califiornia San Diego
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
H. Irene Su, MD, MSCE
University of California, San Diego
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 27, 2024
First Posted
October 29, 2024
Study Start
December 1, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
- Access Criteria
- 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).
Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.