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Trial Title:
Intervening on Women's Health for Rural Young Cancer Survivors
NCT ID:
NCT06664034
Condition:
Cancer
Fertility Issues
Contraception
Conditions: Official terms:
Infertility
Conditions: Keywords:
Reproductive health
Oncofertility
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
single arm pilot hybrid type I trial
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Multi-component reproductive health care intervention
Description:
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.
Arm group label:
Multi-component intervention
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
15 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
San Diego State University - Imperial Valley/ School of Nursing
Address:
City:
Brawley
Zip:
92227
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Cancer Resource Center of the Desert
Address:
City:
El Centro
Zip:
92243
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
El Centro Regional Medical Center
Address:
City:
El Centro
Zip:
92243
Country:
United States
Status:
Recruiting
Contact:
Last name:
H. Irene Su, MD, MSCE
Email:
hisu@health.ucsd.edu
Facility:
Name:
University of Califiornia San Diego
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Active, not recruiting
Start date:
October 23, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
University of California, San Diego
Agency class:
Other
Collaborator:
Agency:
San Diego State University
Agency class:
Other
Collaborator:
Agency:
Cancer Resource Center of the Desert
Agency class:
Other
Collaborator:
Agency:
El Centro Regional Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of California, San Diego
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06664034
