This trial tests how well the symptom management and transitioning to engagement with post-treatment care (STEPS) program works to provide developmentally relevant care for adolescent and young adult (AYA) cancer survivors. Following completion of therapy, most AYAs are gradually lost to follow-up with their oncology team while also failing to establish care with other medical providers to address their cancer-related risks and continued care needs. This can lead to inadequate surveillance for late effects and missed opportunities for symptom management and psychological support. The AYA STEPS program provides training in symptom coping and health care engagement skills which may lead to reduced symptom burden and improved symptom management and health care engagement for AYA cancer survivors.
Additional locations may be listed on ClinicalTrials.gov for NCT06371768.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Caroline S Dorfman
Phone: 919-613-5550
PRIMARY OBJECTIVES:
I. Examine whether AYA STEPS improves survivors’ symptom (i.e., pain, fatigue, emotional distress) burden.
II. Examine whether AYA STEPS improves survivors’ health care engagement.
III. Examine whether AYA STEPS leads to increased symptom management self efficacy and patient activation; determine whether changes in these variables mediate the impact of AYA STEPS on symptom burden and care engagement.
EXPLORATORY OBJECTIVES:
I. Examine the impact of AYA STEPS on health care utilization.
II. Examine social determinants of health (e.g., area deprivation index, health literacy) as moderators of intervention effects.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I:
INTERVENTION: Patients receive access to the web-based application (app), compete six web-based sessions led by a clinical psychologist over 45-60 minutes every other week for 12 weeks. Sessions include skills use and training, problem solving and goal setting. Patients also receive personalized electronic nudges, including problem-solving tips, positive reinforcement, and home-practice reminders. Patients receive access to written information, supplemental videos, pictures, diagrams, and worksheets and receive a printed workbook.
MAINTENANCE: Patients complete questionnaires regarding symptom ratings and skills use via the web-based app and receive nudges based on their responses and to encourage continued use for 12 weeks.
ARM II:
INTERVENTION: Patients receive access to the web-based app, compete six web-based sessions by a clinical psychologist over 45-60 minutes every other week for 12 weeks. Sessions include check in-and content review, education regarding symptom management and post-treatment care and question and discussion. Patients also receive electronic nudges. Patients receive access to written information, supplemental videos, pictures, diagrams, and worksheets and receive a printed manual.
MAINTENANCE: Patients continue to have access to the web-based app and review the maintenance education content and receive nudges to remind them to engage with the content for 12 weeks.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorCaroline S Dorfman
