Projects
Our research projects are focused on oncology and hematopoietic stem cell transplant patients.
Who’s It? Understanding Allocation of Treatment Responsibility in Adolescent and Emerging Young Adult Hematopoietic Stem Cell Transplant Patients
In collaboration with Dr. Micah Skeens at Nationwide Children’s Hospital we are conducting a study to examine associations between allocation of treatment responsibility (ATR) and adherence among adolescent and emerging adult (AEA) hematopoietic stem cell transplant (HCT) recipients and primary caregiver dyads in the acute outpatient phase post-HCT (i.e., first 3 months post-discharge). We will also examine demographic (e.g., sex, age, income), medical (e.g., diagnosis, length of therapy, type of transplant) and family factors (e.g., family communication, barriers) in the prediction of level of adherence over time. For this study we will be recruiting 20 AEA’s and their caregivers.
Evaluation of Two Implementation Strategies for the Psychosocial Assessment Tool (PAT) across 18 Children’s Cancer Centers (iPAT)
In collaboration with Drs. Kazak (Nemours Children's Hospital) and Barakat (Children's Hospital of Philadelphia) the Patient and Family Wellness Center and the Pai Lab are honored to be a site for the iPAT project. This purpose of this study is to test the comparative effectiveness of two PAT implementation strategies. We are one of 18 previously identified pediatric cancer centers across the US varying in size based on new pediatric cancer patients annually – Small, 30-60 (n=6); Medium, 61-149 (n=6); Large, 150+ (n=6). CHOP and Nemours will enroll a total of 45-99 provider participants, including 1-4 staff members to screen at each site, a Site Principal Investigator, and a Champion if randomized to Strategy II. The intervention being tested is the implementation strategies. Strategy I involves an informational webinar that serves to train screening staff on administration of the PAT and a site-specific PAT Implementation Plan plus technical support. Strategy II involves the same webinar training and PAT Implementation Plan plus the addition of two supports – monthly group consultation calls with screening staff and study PIs (Learning Collaborative) and a defined Champion at the site to support implementation efforts.
Adherence Studies in HSCT
Hematopoietic stem cell transplant (HSCT) is a treatment for pediatric patients with a wide range of serious immunological, hematological and oncological diagnoses. The first 6- to 7-months post-HSCT is a critical period during which children are most at risk for life-threatening infections and graft versus host disease (GVHD). To prevent these serious complications, an intense prophylactic oral medication regimen is prescribed. Non-adherence to this regimen results in suboptimal drug exposure increasing the patient’s risk of these post- transplant complications. Despite this, there are no rigorous scientific studies documenting the modifiable factors that predict non-adherence or how NA impacts HSCT outcomes.
We currently have two studies that will identify factors influencing adherence in pediatric and adolescent / young adult HSCT. The HOME Study will recruit 254 caregivers of children ages ≤ 12 years to complete online questionnaires at discharge, 1-, 3-, 5-, and 7-months post-discharge. The HERO Study will recruit 110 patients ages 13-25 and their caregivers to complete questionnaires at discharge, 1-, 3-, 6-, and 9-months post-discharge. Both studies will assess factors expected to be associated with NA prior to the patient’s discharge. The data from these studies will provide the fundamental knowledge that is needed to develop time- and treatment-specific behavioral and systems-based adherence interventions that will optimize the delivery and efficacy of medical treatments.
Illness Management and Parental Adjustment to Cancer Treatment
Illness uncertainty refers to the experience of illness-related events that are unpredictable, ambiguous, and / or complex in nature. For children with cancer and their parents illness uncertainty is ubiquitous as they are suddenly and repeatedly confronted with ambiguous physical symptoms, complex treatment regimens and – most fundamentally – unpredictability regarding the child’s survival. Illness uncertainty is also a consistent and robust predictor of psychological distress. Therefore, the inherent uncertainty of pediatric cancer places both children with cancer and their parents at increased risk for psychological distress e.g., depression, post-traumatic stress symptoms (PTSS) for years following diagnosis and treatment. To date no study exists that provides a psychosocial intervention to parents of children newly diagnosed with cancer and also asses the effect on child psychological functioning.
The proposed trial will test the efficacy of the parent-focused clinic-based Parent Uncertainty Management Intervention (PUMI) to improve the outcomes of children newly diagnosed with cancer and their parents. Two hundred and ninety-six parents of children between two and 18 years of age will be randomly assigned to receive equivalent doses of either the PUMI or an Education / Support (ESO) group. Theoretically driven by Mishel’s model of illness uncertainty, the PUMI will teach parents about uncertainty prevention and management through the use of medically-specific communication, information management, and problem-solving skills via in-clinic sessions and an online portal. Parents and children (> 8 years-old) will complete measures online at baseline, 1-week, and 3-, 6-, and 12-month follow-ups.
