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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05443737
Other study ID # 800780
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 1, 2022
Est. completion date August 31, 2027

Study information

Verified date December 2023
Source University of California, San Diego
Contact H. Irene Su, MD, MSCE
Phone 858-822-5986
Email hisu@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.


Recruitment information / eligibility

Status Recruiting
Enrollment 2800
Est. completion date August 31, 2027
Est. primary completion date August 31, 2027
Accepts healthy volunteers No
Gender All
Age group 0 Years to 50 Years
Eligibility Inclusion Criteria: - Newly diagnosed cancer or cancer relapse - Primary language English or Spanish - Receiving oncology care at participating clinical sites - Ages 0 to 42 years if female - Ages 0 to 50 years if male Exclusion Criteria: - Non-melanoma skin cancer, because primary treatment is excision with no infertility risk - Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multi-component oncofertility care intervention
The multi-component oncofertility care intervention includes: (1) an adaptive and smart default electronic health record-based oncofertility needs screen and referral pathway, (2) telehealth oncofertility counseling as indicated, and (3) telehealth oncofertility financial navigation as indicated.

Locations

Country Name City State
United States City of Hope Duarte California
United States Cancer Resource Center of the Desert El Centro California
United States University of California San Diego La Jolla California
United States Rady Children's Hospital San Diego San Diego California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Diego City of Hope Medical Center, Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care The proportion of eligible reproductive-aged male and female patients (aged 12 to 39 years) who engage in oncofertility services (1| an oncofertility needs screen, 2| referral to oncofertility consult, 3| oncofertility consult, and/or 4| fertility preservation services) that meet the patient's individual needs will be abstracted from medical records using standardized case report forms. 12 weeks after oncology visit
Primary Decisional Conflict The 16-item Decisional Conflict Scale (DCS) will be used to measure patients' decisional conflict for engaging in fertility preservation services. The DCS consists of 16 statements with 5 response options (ranging from strongly agree to strongly disagree) that measures the patient's perceptions of uncertainty in choosing options, feeling informed, values clarity, support in decision making, and effective decision making. The DCS total score will be dichotomized at 37.5 (scale 0-100; > 37.5 indicates high decisional conflict). 12 weeks after oncology visit
Secondary Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care The proportion of eligible female and male patients (aged 0 to 42 years for females; 0 to 50 years for males) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms. 12 weeks after oncology visit
Secondary Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care The proportion of eligible female patients (aged 0 to 42 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms. 12 weeks after oncology visit
Secondary Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care The proportion of eligible male patients (aged 0 to 50 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms. 12 weeks after oncology visit
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