Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of California, San Diego
- Enrollment
- 2800
- Locations
- 4
- Primary Endpoint
- Decisional Conflict
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Hui-Chun Irene Su
Professor
University of California, San Diego
Eligibility Criteria
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
Outcomes
Primary Outcomes
Decisional Conflict
Time Frame: 12 weeks after oncology visit
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).
Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care
Time Frame: 12 weeks after oncology visit
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.
Secondary Outcomes
- Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care(12 weeks after oncology visit)
- Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care(12 weeks after oncology visit)
- Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care(12 weeks after oncology visit)