Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-50
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis
Trial design
Design model
Sequential
Treatments tested in this trial
Multi-component oncofertility care intervention
BehavioralThe 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.
Treatment groups
2,800 Participants
are divided into 2 treatment groupsGroup A: Multi-component oncofertility care interventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 weeks after oncology visit2
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).
Time frame
12 weeks after oncology visitSecondary outcomes
1
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.
Time frame
12 weeks after oncology visit2
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.
Time frame
12 weeks after oncology visit3
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.
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
Rady Children's Hospital, San Diego
Collaborator
City of Hope Medical Center
Collaborator
Source ClinicalTrials.gov