Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients

Cancer Clinical Trial

Official title:

Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443737
• Other study ID #: 800780
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Cancer
• Fertility Preservation

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