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Principal Investigator: NINA S KADAN-LOTTICK
Organization: GEORGETOWN UNIVERSITY
Fiscal Year: 2024
Award: $625,358
Funding agency: National Cancer Institute
PROJECT SUMMARY
More than 80% of childhood cancer survivors (CCS) develop serious or life-threatening late effects. Yet <20%
of CCS receive recommended survivorship care, despite the availability of consensus guidelines for lifelong
surveillance for late effects starting 2 years post-therapy. The “gold standard” cancer center-based survivorship
clinic provides high-quality care to CCS who attend, but patients avoid reminders of their past cancer and lack
knowledge and self-efficacy for survivorship care. Other barriers include travel distance, inadequate insurance,
and out-of-pocket costs—these structural issues contribute to health disparities. Partnering with community
primary care provider (PCP) clinics in a shared model of care is a promising strategy to overcome these barriers,
but PCPs lack knowledge, self-efficacy, and interactive communication with the cancer center and are confused
about the division of care responsibilities. Our intervention is scalable and distance-based, is informed directly
by patient and PCP barriers and preferences from previous studies, and is boosted by a nationwide explosion in
telehealth services precipitated by the COVID-19 crisis. The proposed randomized controlled trial will enroll 240
CCS 2.0-4.0 years post-chemotherapy/radiation to investigate an innovative multi-level intervention (i.e.,
interpersonal and organizational levels) consisting of 1) patient survivorship education via telehealth with the
cancer center, 2) ongoing patient-tailored education program within the EHR's patient portal, 3) a structured
interactive phone communication between the cancer center and the PCP clinic (with 1-year follow-up call), and
4) an in-person visit with the PCP clinic for survivorship care. The comparison group will be randomized to an
in-person visit with their cancer center survivorship clinic. This study includes 4 centers with high proportions of
subgroups vulnerable to survivorship care disparities (i.e., rural, Black, Latinx, Spanish-speaking,
socioeconomically disadvantaged). Both groups will be asked to begin recommended surveillance for late effects
within 1-year post-randomization, separate from tumor recurrence monitoring by the primary oncologist. Our
Specific Aims are to Aim 1- Demonstrate patient completion of guideline-recommended surveillance tests in
intervention participants is not inferior, i.e. within 10%, to that in the comparison group; Aim 2- Achieve greater
1) patient knowledge, self-efficacy, and activation and 2) PCP knowledge and self-efficacy with survivorship care
among intervention participants and their PCPs compared to the comparison group; and Aim 3- Ascertain
process outcomes for the 1) patient and 2) PCP clinic. Outcomes will also be assessed among subgroups with
survivorship care disparities. Transformative Impact: If our intervention demonstrates patient completion of
recommended survivorship care comparable to cancer center survivorship clinic, our study has the enormous
potential to deliver recommended lifelong care to a larger proportion of CCS and reduce survivorship care
disparities, while engaging patients and PCPs to integrate survivorship care as part of overall, lifelong health
maintenance.
Terms: <Active Follow-up><Adherence><Adverse Late Effects><Age><Black><Black race><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><CTCAE><Cancer Center><Cancer Survivor><Cancer Survivorship><Cancer Treatment><Cancers><Caring><Childhood Cancers><Clinic><Collaborations><Common Terminology Criteria for Adverse Events><Common Toxicity Criteria><Communication><Communities><Confusion><Confusional State><Consensus><Diagnosis><Disparities><Disparity><Dissemination and Implementation><Education><Educational aspects><Electronic Health Record><Eligibility><Eligibility Determination><Enrollment><Ensure><Espanol><Explosion><Goals><Guidelines><Health><Health Services><Institution><Insurance><Interactive Communication><Intervention><Intervention Strategies><Interview><Knowledge><Late Effects><Latine><Latinx><Life><Maintenance><Malignant Childhood Neoplasm><Malignant Childhood Tumor><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Pediatric Neoplasm><Malignant Pediatric Tumor><Malignant Tumor><Malignant childhood cancer><Medical Records><Mental Confusion><Methods><Modeling><Monitoring for Recurrence><Oncologist><Out-of-Pocket Expense><Outcome><Patient Care><Patient Care Delivery><Patient Education><Patient Instruction><Patient Training><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Persons><Phone><Physicians><Process><Protocol Screening><QOC><Quality of Care><Radiation><Randomized><Randomized, Controlled Trials><Recommendation><Recurrent Neoplasm><Recurrent tumor><Research Resources><Resources><Rural><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Sampling><Self Efficacy><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Site><Socioeconomically disadvantaged><Spanish><Specialty><Structure><Subgroup><Survey Instrument><Surveys><Technology><Telephone><Testing><Text Messaging><Travel><Uncovered Medical Expenses><Uncovered Uninsured Medical Expense><Uninsured Medical Expense><Visit><Work><acceptability and feasibility><active followup><adherence rate><ages><anti-cancer therapy><arm><cancer in a child><cancer in children><cancer therapy><cancer-directed therapy><care for patients><care of patients><caring for patients><chemotherapy><child with cancer><childhood cancer survivor><childhood malignancy><comparator group><comparison group><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><direct patient care><disparity gap><disparity in health><electronic health care record><electronic health medical record><electronic health plan record><electronic health registry><electronic medical health record><enroll><equity gap><follow up><follow-up><followed up><followup><future implementation><gap in equity><gap in inequality><gap in inequity><health disparity><improved><individual patient><inequality gap><inequitable gap><inequity gap><innovate><innovation><innovative><instrument><intervention participants><interventional strategy><malignancy><medical expenses not covered by insurance><medical specialties><neoplasm recurrence><neoplasm/cancer><out-of-pocket costs><out-of-pocket health care costs><participant engagement><patient engagement><patient health information><patient health record><patient medical record><patient oriented outcomes><patient portal><pediatric cancer><pediatric cancer survivor><pediatric malignancy><preference><primary care clinic><primary care provider><primary end point><primary endpoint><primary outcome><programs><provider barriers><provider-level barriers><providers from primary care><providers of primary care><randomisation><randomization><randomized control trial><randomly assigned><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><short message service><socio-economic disadvantage><socio-economically disadvantaged><socio-economically underprivileged><socioeconomic disadvantage><socioeconomically underprivileged><survivorship><telehealth><texting><total medical expenditure>