Barakat Laboratory Research Overview

Adolescents and youth adults (AYA; ages 15-29) with cancer are an incredibly vulnerable group relative to pediatric patients as their cancer incidence is increasing and outcomes vary based on sociodemographic characteristics, access to comprehensive care, and access to clinical trials. As AYA care involves multi-level systems of caregivers, healthcare teams, and pediatric and adult medicine, AYA development of individuation and autonomy may be stifled in the face of cancer, resulting in less involvement in cancer-related decision-making.

Our and others’ research suggests that AYA are less involved in cancer-related decision-making at diagnosis and throughout treatment than AYA prefer, potentially limiting trial enrollment, engagement in care, and well-being. AYA experience decision conflict and regret when they perceive they have not received all cancer information, what is important to them is not considered, and they are not involved. AYA engagement in cancer-related decision-making (i.e., having a “voice”) could influence outcomes in the short-term (e.g., participating in lifesaving clinical trials, engagement in treatment, well-being) and long-term (e.g., playing an active role managing their survivorship care as they age into adulthood).

Decision support interventions, efficacious with adults with cancer but not fully tested for AYA, hold promise for increasing engagement and involvement in cancer-related decision-making, including for clinical trials. Such interventions can connect AYA to reliable cancer information to enhance knowledge, support AYA values clarification, and facilitate AYA-clinician communication. There is a critical need to develop and implement evidence-based AYA decision-making interventions to improve disparities in their cancer care and outcomes. To address this critical need, funded by the B+ Foundation, we recently tested one of the first decision support interventions (DECIDES) for AYA ages 15-24 years within six weeks of diagnosis in a randomized trial to assess acceptability, feasibility, and preliminary efficacy. Theoretically based, AYA informed, and web-based, DECIDES components were designed to enhance cancer-related knowledge and treatment attitudes, values clarification, and AYA-clinician communication. AYA randomized to DECIDES reported significantly more decision-making involvement and less decision regret than AYA in usual care.

AYA, caregivers, and clinicians rated DECIDES as highly acceptable and usable but recommended access even closer to diagnosis and optimization of the website across digital platforms. Data analyses are on-going including a description of values considered in decision-making. Our long-term goal is to optimize medical and psychosocial outcomes for AYA through improved cancer-related decision-making.

Despite being the most impacted of all childhood cancer survivors according to critical indicators of long-term functioning and development, young adult survivors (YAS) of a childhood brain tumor and their caregivers remain underserved and understudied. YAS often experience physical, cognitive, and psychosocial late effects of their tumor and treatment that limit self-awareness, self-management skills, and capacity for independence. As a result, they often require ongoing self-management support (i.e., integrating condition management into daily life) and a continuation of family management responsibilities (i.e., integrating condition management into family life) from their primary, often maternal, caregiver, into young adulthood and beyond.

While evidenced-based interventions exist to support families at diagnosis, there are few resources and services available to support long-term self- and family management of YAS. Our past research with families of YAS underscores the importance of addressing these unmet needs, finding that increased caregiver-reported challenges to family management were significantly related to decreased YAS and caregiver health-related quality of life. Web-based applications focused on improving the health-related quality of life for caregivers and YAS can decrease disparities in care by increasing access to supportive programs.

Based on the Self- and Family Management Model and the Family Management Styles Framework, Training in Problem-Solving (TIPS) is a web-based, coach-assisted, problem-solving intervention developed in response to the unmet need of caregivers and YAS during the transition to adulthood. TIPS was adapted from Bright IDEAS for Everyday Living (an evidence-based intervention for caregivers of children newly diagnosed with cancer) to incorporate key components of family management.

In a pilot randomized trial, the preliminary efficacy of TIPS compared to Enhanced Usual Care (usual care plus survivorship-based resources) and acceptability and feasibility of TIPS were evaluated using questionnaires and qualitative interviews. Data analyses on the primary hypotheses and to evaluate key factors for intervention implementation with caregivers of young adult survivors are underway.

Research in pediatric oncology suggests that autonomy, general well-being, and adherence to treatment are improved when caregivers and healthcare providers incorporate adolescents’ and young adults’ (AYA) values into the decision-making process. Values-based decision-making is when a person makes an informed decision that aligns with their personal values and preferences. A robust literature addresses decision-making for oncologic disease in the adult population, reporting that patients place highest importance on quality of life during or after treatment, life expectancy, opinions of the medical team, and preferences of the patient’s family. There is an emerging body of primarily qualitative research in pediatric oncology patients, highlighting areas for continued investigation into how to best support patients and caregivers in cancer-related decision-making.

Research in pediatric and AYA oncology has focused on initial treatment decision-making, which demonstrates patients’ desire to return to normalcy and to maintain relationships with peers and family. However, we lack research on how patients and caregivers make treatment-related decisions for relapsed and refractory disease. Further, existing research demonstrates that the AYA population struggles to vocalize preferences unless clinicians directly communicate with them during treatment planning meetings. However, studies in patients younger than 12 years old are limited. Shared decision-making has been found to decrease decisional regret, an affect associated with anxiety, depression, and poor prognosis in the AYA population.

The objective of this qualitative, cross-sectional study is to investigate how patients’ and caregivers’ values influence the decisions made regarding treatment of relapsed and refractory oncologic diagnoses, utilizing interviews of adolescent and young adult patients and younger pediatric patients. We will elucidate the value domains most important to pediatric patients and/or caregivers in the study populations when making treatment-related decisions, as past research has demonstrated high importance in domains such as mental wellness, physical well-being, self-advocacy, and interpersonal relationships. Secondarily, we will explore the ways in which those values influence treatment-related decision making. Long term, we seek to determine how incorporation of these values by the patient’s primary oncology team leads to improved patient and/or caregiver-reported outcomes.

Psychosocial Assessment Tool

The diagnosis and treatment of pediatric cancer adversely affects multiple levels of the social ecology, including patient and caregiver physical and psychosocial health. Families with limited instrumental (i.e. financial) and social resources and pre-existing child and family problems are particularly at risk for health disparities. Institute of Medicine Reports and the Standards of Psychosocial Care in Pediatric Cancer call for improvement in delivery of psychosocial care.

The Standards outline evidence-based care for all patients and families to improve health, increase access to care, and reduce health disparities by decreasing distress, addressing risks, and improving quality of life. The first standard is “youth with cancer and their family members should routinely receive systematic assessment of their psychosocial healthcare needs.” Universal screening at diagnosis fosters early identification of psychosocial risks and provides the opportunity to match psychosocial care to the level of family need for more equitable, effective, and integrated services. Few programs offer such care in an efficient, comprehensive, consistent manner, highlighting critical gaps in psychosocial pediatric cancer care that can magnify health disparities.

With support from the American Cancer Society, we validated a theoretically based, reliable, web-based, parent report screener of family psychosocial risk, the Psychosocial Assessment Tool (PAT), in English and Spanish. The PAT is ideally poised for broad dissemination across pediatric cancer centers. Screening is not routinely implemented due to multi-level patient/family, provider, and institutional barriers (e.g., challenges of screening, provider time and effort, resources to respond to risks). The goal of this study is to create and broadly disseminate an implementation toolkit to facilitate acceptable, feasible, and sustainable family psychosocial risk screening in English and Spanish. Based on the Interactive Systems Framework for Dissemination and Implementation (ISF), the implementation toolkit will be developed in three stages in this mixed methods research.

• First, two implementation strategies, to improve integration of the PAT into standard pediatric cancer care, will be refined using feedback from 18 community members using qualitative methods. The strategies are based on prior PAT studies, the dissemination and implementation literature, and Social Ecological and Pediatric Psychosocial Preventative Health Models. Strategy I is Training via webinar to educate providers on PAT administration. Strategy II is Training + Implementation Expanded Resources (TIER), which augments training with Consultation Calls and a Champion.
• Second, we will conduct a comparative effectiveness trial of the two strategies at 18 childhood cancer centers of three sizes based on new patients per year, examining family (i.e.., penetration, health equity), provider (i.e., feasibility, acceptability, burnout, and job satisfaction), and institution (i.e., adoption, sustainability, costs) implementation outcomes. We will randomize sites to time of implementation (three cohorts) and Strategy I or II.
• Third, we will develop and disseminate a PAT Implementation Toolkit for family psychosocial risk screening in pediatric cancer.

Family psychosocial screening, a Standard of Care, if implemented universally and systematically, may reduce disparities in the delivery of psychosocial care for children in pediatric cancer by facilitating care matched to need at multiple levels of the social ecology. This study will result in the broad dissemination of a PAT Implementation Toolkit for successful and sustainable implementation of universal, comprehensive, evidence-based family psychosocial risk screening in standard pediatric psychosocial care for all families of children with cancer.

A large body of research confirms the presence of psychosocial distress and resiliencies of families as they initiate and complete pediatric cancer treatment. The diagnosis and treatment of pediatric cancer adversely affects multiple levels of the social ecology, including patient and caregiver physical and psychosocial health. Particularly at risk for health disparities and challenges traversing cancer care are families with limited instrumental and social resources and pre-existing child and family problems. If untreated, psychosocial stress has the potential to escalate and negatively impact cancer care and outcomes.

While evidence-based assessment and intervention approaches relevant across the course of treatment have been developed, efforts to screen for physical quality of life and psychosocial stressors and strengths remain inconsistent, thereby impacting access to and engagement in cancer care, care matched to need, and psychosocial adaptation As a result, researchers at the Center for Childhood Cancer Research (CCCR) led by Dr. Barakat, are analyzing the acceptability, feasibility, and validity of tools used for psychosocial screening at various time points across the course of treatment to improve health equity and outcomes for children with cancer and their families.

Psychosocial screening is recognized as necessary and important early in treatment to ensure optimal, efficient care and access to evidence-based psychosocial services. Early, systematic assessment of psychosocial risks and resources facilitates the delivery of evidence-based psychosocial interventions at critical times over the cancer treatment trajectory. Prompt assessment of the psychosocial risks and needs of families facing pediatric cancer treatment promotes delivery of psychosocial care in a systematic way that addresses the family’s needs while leveraging family resources to reduce distress and improve treatment outcomes including health-related quality of life.

Researchers at the CCCR are using psychosocial assessment tools to learn more about children and families’ psychosocial risk and resources at multiple points throughout treatment, starting at four to six months post diagnosis, followed by 18 months post diagnosis, and lastly at five years post diagnosis. Screening is completed by one caregiver and by patients 11 years of age and older.

Questionnaires assess cancer-related symptoms; patient medication management; patient physical symptoms; social interactions and emotional functioning; patient neurocognitive and school functioning; caregiver functioning and quality of life; and support and resources. While use of these tools is valid for assessing psychosocial risk at the time of diagnosis, evaluating its efficacy to identify changes in family needs and psychosocial risk at multiple time points throughout treatment is critical to effectively direct psychosocial care that matches the needs of families during cancer treatment and beyond.

Additionally, we evaluate our implementation process and measure acceptability and feasibility through structured interviews with clinicians, patients, and families. Furthermore, this research aims to address potential cancer healthcare disparities in psychosocial care by establishing a valid screening approach (Psychosocial Assessment Tool 2.0) for English, Spanish, and Arabic speaking families in the pediatric cancer setting. The goal is for universal psychosocial screening to be integrated into standard clinical practice to promote appropriate intervention and diminish disparities in care and outcomes, including those for non-English-speaking families. Once the utility of universal psychosocial screening has been determined, researchers can use established methods to implement psychosocial screening in clinical care, disseminate findings to the healthcare team, and incorporate information on family risks and resources into psychosocial management and support for children, adolescents, and young adults with cancer and their families.

The evidence base on interventions for bereaved parents is limited, and existing grief interventions are inadequate to counter bereaved parents’ physical and mental health morbidity. To date, there are no interventions developed specifically for parents bereaved by cancer despite their unique care needs. Currently, supportive psychotherapy (SP), which facilitates emotional expression and post-loss adjustment, is the most practiced grief counseling approach. However, there is little empirical support on SP’s effects in parents bereaved by cancer. As such, an acceptable, evidence-based, time-limited approach to reduce parents’ suffering is sorely needed.

The primary objective of this five-year, National Institutes of Health-funded, multisite randomized controlled is to compare the effectiveness of three different types of support (i.e., Enhanced Usual Care, Supportive Psychotherapy, and Meaning-Centered Grief Therapy) in reducing prolonged grief and depression symptoms among bereaved parents of childhood cancer.

Enhanced Usual Care is a support program that includes resources only in addition to usual standard of care (i.e., no one-on-one counseling), Supportive Psychotherapy is a one-on-one non-directive and non-specific intervention that offers parents a safe, protected space to share challenges they face in the here and now, and Meaning-Centered Grief Therapy is a manualized, one-on-one cognitive-behavioral-existential intervention that uses psychoeducation and experiential exercises to assist parents with understanding how sources of meaning can be used for coping with grief and to facilitate a continued connection to their child. Recruitment for this study is ongoing across sites.

We are working with Principal Investigator Wendy Lichtenthal, PhD, research associate professor of Public Health Science at the University of Miami, to evaluate MCGT’s effectiveness in reducing prolonged grief symptoms and other indicators of parent well-being.