Intervening on Women's Health for Rural Young Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-50
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cancer (Stages 0-IV) diagnosis
Primary language English or Spanish
Receiving oncology care at rural oncology clinical participating site
Living in Imperial County, California
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Multi-component reproductive health care intervention
BehavioralThe 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.
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: Multi-component interventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 weeks after oncology visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
San Diego State University
Collaborator
Cancer Resource Center of the Desert
Collaborator
El Centro Regional Medical Center
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov