Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06371768
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • AYA Educational Information — BEHAVIORAL
    AYA-specific educational information is delivered using video conferencing by a clinical psychologist over six sessions. Participants will receive a written manual providing tips for engaging with educational content as well as access to a website specific to the control arm, which will provide written, video, and pictorial information.
  • AYA STEPS — BEHAVIORAL
    The intervention provides cognitive-behavioral and patient activation theory-based skills designed to enhance AYA survivors' abilities to manage their high symptom burden and engage in follow-up health care. Sessions with the psychologist will focus on enhancing participants' abilities to apply intervention skills and engage in the AYA STEPS digital health intervention using motivational interviewing, goal setting, and problem-solving techniques. Participants will complete the six sessions over the 12 weeks of the AYA STEPS intervention.

Study Details

The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care.

Key Dates

Start date
Jul 14, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Education Control
    The education control condition will match AYA STEPS in delivery format \[videoconferencing, web-based platform, frequency (biweekly sessions)\], and session number (six) and length.
  • Experimental: AYA STEPS
    Participants will receive the AYA STEPS digital health intervention, which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist with intervention content accessed using a web-based platform.

Primary Outcome Measure

Pain severity and interference as measured by Brief Pain Inventory [ Time Frame: Baseline, 3 Months, 6 Months, 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer InstituteDurhamNorth Carolina27705
Michael W Willis
[email protected]
919-681-8437
Smrithi Divakaran, MPH
[email protected]
919-681-7695
Caroline Dorfman, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke Cancer Institute· Durham, NC

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