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Intervening on Women's Health for Rural Young Cancer Survivors

Intervening on Women's Health for Rural Young Cancer Survivors

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06664034
Enrollment
42
Registered
2024-10-29
Start date
2024-12-01
Completion date
2026-05-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Contraception, Fertility Issues

Keywords

Reproductive health, Oncofertility

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.

Interventions

BEHAVIORALMulti-component reproductive health care intervention

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.

Sponsors

University of California, San Diego
Lead SponsorOTHER
San Diego State University
CollaboratorOTHER
Cancer Resource Center of the Desert
CollaboratorUNKNOWN
El Centro Regional Medical Center
CollaboratorUNKNOWN
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

single arm pilot hybrid type I trial

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Cancer (Stages 0-IV) diagnosis * Primary language English or Spanish * Receiving oncology care at rural oncology clinical participating site * Living in Imperial County, California

Exclusion criteria

\- Women who are pregnant at recruitment

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patient's engagement in goal-concordant reproductive health care12 weeks after oncology visitStudy 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORH. Irene Su, MD, MSCE

University of California, San Diego

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026