Grant Number:	1R21CA263727-01A1 Interpret this number
Primary Investigator:	Dorfman, Caroline
Organization:	Duke University
Project Title:	Improving Symptom Management for Adolescents and Young Adults with Advanced Cancer: Development and Pilot Testing of a Novel Intervention
Fiscal Year:	2022

Each year more than 30,000 adolescents and young adults (AYAs) aged 15 to 29 are diagnosed with cancer in the United States. AYAs are more likely to present with advanced disease and more aggressive tumors, and have worse prognosis when compared with younger and older cancer patients. AYAs with advanced cancer are also challenged by high psychological (e.g., anxiety, depression) and physical (e.g., pain) symptom burden. Despite this, AYAs with advanced cancer are underserved in palliative care. Adult palliative care services primarily treat older cancer patients (mean age 60-65); thus, the majority of psychosocial symptom management interventions have been tested among individuals aged >40. There too remains a gap in pediatric palliative care for AYA patients where services are typically focused on the needs of patients aged <15. AYAs are diagnosed during a critical developmental period when they are working to achieve complex, age-related goals (e.g., completing their educations, achieving autonomy, building their careers, fostering relationships, building families). The combination of physical symptoms, psychological distress, and challenges to achieving developmental milestones may exacerbate patient suffering; yet, the unique, age-related needs of AYAs with advanced cancer often go unrecognized. The proposed project will begin to fill this gap. The study aims to develop and test the feasibility and acceptability of a psychosocial symptom management intervention designed to meet the unique needs of AYAs with advanced cancer. The proposed intervention will combine traditional behavioral symptom management strategies commonly use in the palliative care setting with important skills and concepts from Meaning-Centered Psychotherapy and Acceptance and Commitment Therapy. Skills from these approaches may be particularly relevant to AYAs with advanced cancer who experience significant disruption in life goals from cancer and associated symptoms and may have greater difficulties understanding and finding meaning in their lives than older and younger patients. Intervention content, structure, and study procedures will be informed by qualitative data obtained during focus groups with patient (n=16) and caregiver (n=12) stakeholders as well as review by patient user testers (n=3). It is anticipated that the intervention will include four weekly sessions spaced over 6-8 weeks and be delivered using videoconferencing. Next, AYAs with advanced cancer (N=40) will be randomized to the intervention or education control arms using an allocation ratio of 1.5: 1. We will examine the feasibility of study recruitment and retention, acceptability, and changes in variables of interest (i.e., physical and psychological symptoms, symptom interference, self-efficacy for symptom management, experiential avoidance, values) over time for the intervention and control arms. Participants will also provide feedback on study materials, intervention format, and the appropriateness of the intervention to the population and advanced stage of disease. Information obtained from this pilot study will well position the PI and investigative team to examine the efficacy of the developed intervention in a larger randomized controlled trial.





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