Intervening on Women's Health for Rural Young Cancer Survivors

NCT ID: NCT06664034

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Fertility Issues Contraception

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single arm pilot hybrid type I trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Multi-component intervention

After the intervention implementation, all cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component intervention.

Group Type EXPERIMENTAL

Multi-component reproductive health care intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Multi-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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

Cancer Resource Center of the Desert

UNKNOWN

Sponsor Role collaborator

El Centro Regional Medical Center

UNKNOWN

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Hui-Chun Irene Su

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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H. Irene Su, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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San Diego State University - Imperial Valley/ School of Nursing

Brawley, California, United States

Site Status ACTIVE_NOT_RECRUITING

Cancer Resource Center of the Desert

El Centro, California, United States

Site Status ACTIVE_NOT_RECRUITING

El Centro Regional Medical Center

El Centro, California, United States

Site Status RECRUITING

University of Califiornia San Diego

La Jolla, California, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Sally Romero, PhD, MPH

Role: CONTACT

858-822-1371

H. Irene Su, MD, MSCE

Role: CONTACT

858-822-5986

Facility Contacts

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H. Irene Su, MD, MSCE

Role: primary

Other Identifiers

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5U54CA285115-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U54800646

Identifier Type: -

Identifier Source: org_study_id

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