Download Establishment of a County Hospital-Based

Establishment of a County Hospital
Based Program for Older
Adolescents and Young Adults with
Cancer
Gail Tomlinson, M.D.,Ph.D.
School of Medicine
Department of Pediatrics
Definition of AYA
Adolescents and Young Adults
undergoing cancer treatment
Age range defined by NIH
as 15 to 39 years
Purpose of Presentation
• Feedback and suitability for PCORI funding
• Feedback on possible partners
• Feedback on study design
• Other suggestions
Proposed PCORI Mechanism
and Why PCORI
• PCORI Mechanism:
– Improving Health Care Systems
• Why:
– Well-described gap in quality and structure of care in
older adolescents and young adults with cancer
– Public health system has additional challenges
– Opportunity for improvement in outcome
– Significant expertise and interest in Peds / Med 0nc
Gap Analysis
• NCCN Statement 2012
– Significant advances in cancer care in older adults and
young chidren but not in the AYA population
– Biology of tumors in this age group is different
– Documented low-rate of enrollment onto clinic trials
(~1-2%)
– Unique needs of AYAs
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Fertility
Psychosocial
Genetic and familial risks
Financial
Palliative care concerns
Many AYA diagnoses are considered
Rare Diseases
• Acute lymphoblastic leukemia
• Hodgkin’s and non-Hodgkin’s lymphoma
• Germ Cell Tumors
• Lynch-syndrome associated colorectal cancers
Overall Goal
• To establish a well-defined comprehensive
hospital-based program for AYAs with new
diagnosis of cancer and to demonstrate
effectiveness
• Support to include:
– Patient navigator
– Partial physician(s) salary
– Psychosocial support
– Partial genetic counselor support
– Research staff
Specific Aims, Research Question, and
Design (as applicable)
• Aim 1. To determine the efficacy of AYA program
in increasing adherence to therapy.
• Comparator: Age and diagnosis matched patients
in previous 5 years
• Metrics:
– Number of missed clinic appointments
– Number of delays in scheduled chemotherapies
– Disease-free and overall survival at 1, 2, and 3 yrs
Specific Aims, Research Question, and
Design (as applicable)
• Aim 2. To increase accruals onto NCIsponsored and other cancer therapy and
supportive care trials.
• Comparator: Age and diagnosis matched
patients in previous 5 years
Specific Aims, Research Question, and
Design (as applicable)
• Aim 3a. To work with institutions within the
Greater Plains Consortium to determine
feasibility of adaptability to other programs
• Survey of current AYA care
– Determine “AYA-ness” of existing care programs
Specific Aims, Research Question, and
Design (as applicable)
• Aim 3b. To work with institutions within the
Greater Plains Consortium to determine
clinical trials enrollment and outcomes within
AYA population,.
• Metrics:
– Percent of patients on clinical trials within the AYA
population
Specific Aims, Research Question, and
Design (as applicable)
• Aim 4. To determine psychological well-being
of AYAs undergoing cancer treatment and
provide improvement where needed
• Standard measures of stress, coping
• Standard measure of impact on genetic risk
assessment (MICRA)
Specific Aims, Research Question, and
Design (as applicable)
• Aim 5. To implement and evaluate video
observation and provider interaction via smart
phone.
• Design appropriate app for symptom intake and
option for individual video communication with
visualization with medical professional.
• Implement in 50% of patients (case/control) to
evaluate feasibilty and acceptance.
Specific Aims, Research Question, and
Design (as applicable)
Aim 6.
• 6a. To determine patient satisfaction with
aspects of AYA care
– Designated unit
– Use of navigator
• 6b. To measure family member satisfaction with
AYA care
• 6c. To measure health care provider satisfaction
with AYA care
Engagement
• How will patients and stakeholders be
involved
– Former AYA leukemia Patient now in 20s; active
on social media, very involved in Be The Match
bone marrow program
– Bright Pink – advocacy and support group for
breast cancer patient ages 18 to 35.
Engagement
• How will patients and stakeholders be involved:
University Hospital / Bexar County Medical
District
Advocate for improved health in Bexar County
Partnering in infrastructure
Study Challenges
• Small to medium sample sizes (~100 patients)
• Suitable controls
• Case-control design with recent historical
controls
• Best methods to assess health care providers