Intervening on Women's Health for Rural Young Cancer Survivors

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.

Recruiting

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Key information

Conditions

Cancer Contraception Fertility Issues Genital Diseases Infertility Neoplasms Urogenital Diseases

Age range

15 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University - Imperial Valley/ School of Nursing, Brawley, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-component reproductive health care intervention

Behavioral

The multi-component reproductive health care intervention includes:

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.
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.
Telehealth reproductive health consultation will occur between the patient and reproductive specialist. Each consultation is estimated to be 1 hour.

Primary outcomes

Proportion of patient's engagement in goal-concordant reproductive health care

Time frame: 12 weeks after oncology visit

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.

Study contacts

Contact information is provided by the study sponsor or research team.

H. Irene Su, MD, MSCE

CONTACT

[email protected]

858-822-5986

Sally Romero, PhD, MPH

CONTACT

[email protected]

858-822-1371

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

Cancer Resource Center of the Desert
El Centro Regional Medical Center
National Cancer Institute (NCI)
San Diego State University

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Oct 29, 2024
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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