Cancer, Fertility Preservation
Conditions
Keywords
Oncofertility, Fertility preservation, Adolescent and young adult cancer
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.
Interventions
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.
Sponsors
Rady Children's Hospital, San Diego
City of Hope Medical Center
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
Fertility specialists and their support staff will be blinded to the intervention status of the cluster from which a patient is referred to minimize differences in counseling in patients whom they expect to receive financial navigation.
Intervention model description
Stepped wedge cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
0 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care | 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. |
| Decisional Conflict | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care | 12 weeks after oncology visit | 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. |
| Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care | 12 weeks after oncology visit | 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. |
Countries
United States
Contacts
Primary ContactH. Irene Su, MD, MSCE
Backup ContactSally AD Romero, PhD, MPH
Outcome results
None listed