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NCT06371768 | NOT YET RECRUITING | Cancer


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

Duke University

Brief Summary:

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.

Condition or disease

Cancer

Breast Cancer

Colorectal Cancer

Sarcoma

Lymphoma

Testicular Cancer

Intervention/treatment

AYA Educational Information

AYA STEPS

Phase

NA

Detailed Description:

The investigators have developed an accessible digital health intervention, AYA STEPS (Symptom Management and Transitioning to Engagement with Post-Treatment Care for AYA Survivors), designed to enhance adolescent and young adult (AYA) cancer survivors' abilities to manage their high symptom burden and engage in follow-up health care. Informed by the Obesity-Related Behavioral Intervention Trials (ORBIT) Model of intervention development, AYA STEPS has been systematically and rigorously developed and refined through the PI's prior work (K08CA245107). AYA STEPS is organized into six remotely delivered sessions providing cognitive-behavioral and patient activation theory-based skills expected to lead to lower symptom burden and increased health care engagement by improving AYAs' self-efficacy for symptom management and activation. The investigators propose a randomized controlled trial to examine the efficacy of AYA STEPS compared to AYA educational information for improving symptom burden and health care engagement for AYA survivors (N=260) who received cancer care in diverse health care settings (i.e., rural, urban, medically underserved areas) across North Carolina. Self-efficacy and patient activation will be examined as mediators of intervention effects. The planned study has the potential to produce clinically impactful health benefits for an underserved and understudied group of cancer survivors who have significant symptom burden, experience barriers to care engagement, and have limited access to AYA-specific behavioral interventions.

Study Type : INTERVENTIONAL
Estimated Enrollment : 260 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2029-06-30
Estimated Study Completion Date : 2029-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 39 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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) 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

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

Location Details

NCT06371768


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