Helping adolescent and young adult cancer survivors manage symptoms and stay engaged in post-treatment care
Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors
This trial will test whether AYA STEPS, a six-session digital program, can help adolescent and young adult cancer survivors reduce symptoms and keep up with recommended follow-up care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06371768 on ClinicalTrials.gov |
What this trial studies
AYA STEPS is a remotely delivered, six-session digital program that teaches cognitive-behavioral skills and patient activation strategies to help survivors manage high symptom burden and engage in follow-up healthcare. In a randomized controlled trial, 260 adolescent and young adult survivors treated across diverse North Carolina settings will be assigned to AYA STEPS or to receive AYA educational information. The trial will measure changes in symptom burden and health care engagement and will examine self-efficacy and patient activation as mediators of any effects. Sessions are designed for remote access to reach survivors in rural, urban, and medically underserved areas.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adolescent and young adult survivors who are 1–5 years post-diagnosis, treated with curative intent for specified early-stage cancers (stage I–III breast, colorectal, sarcoma, Hodgkin or non-Hodgkin lymphoma, or stage I–II testicular) and have been off therapy for at least three months.
Not a fit: Patients with moderate or severe cognitive impairment, severe untreated mental illness, or those still receiving active non-hormonal cancer therapy are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the program could lower symptom burden and improve survivors' follow-up care and long-term health.
How similar studies have performed: Digital cognitive-behavioral and patient-activation programs have shown promise in adult cancer populations, but randomized evidence specifically for adolescent and young adult survivors is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with one of the following cancers: 1) stage I-III breast cancer; 2) stage I-III colorectal cancer; 3) stage I-III sarcoma; 4) stage I-III Hodgkin or non-Hodgkin lymphoma; or 5) stage I-II testicular cancer * treated with curative intent and off therapy (with the exception of endocrine/hormonal therapy or oral targeted therapies used to prevent disease recurrence or progression) for the last three months * 1 to 5 years post-diagnosis * Able to speak and read English * Able to give informed consent Exclusion Criteria: * moderate or severe cognitive impairment * severe untreated mental illness (e.g., schizophrenia, substance use disorder) that would interfere with providing meaningful consent/study participation
Where this trial is running
Durham, North Carolina
- Duke Cancer Institute — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Caroline S Dorfman, PhD
- Email: caroline.dorfman@duke.edu
- Phone: 919-416-3473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.