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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое AYA Educational Information
  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.
• Поведенческое AYA STEPS
  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

Первичные конечные точки

• Pain severity and interference as measured by Brief Pain Inventory [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• Fatigue as measured by PROMIS Fatigue Scale [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• Emotional distress as measured by PROMIS Depression Short Form [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• Emotional distress as measured by PROMIS Anxiety Short Form [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• Health care engagement as measured by Patient Participation Questionnaire [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]

Вторичные конечные точки (4)

• Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• Patient activation as measured by Patient Activation Measure (PAM) [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• Patient self-efficacy for managing chronic conditions as measured by the PROMIS Self-Efficacy for Managing Symptoms Short Form [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]
• General patient self-efficacy as measured by the PROMIS General Self-Efficacy Short Form [Срок оценки: Baseline, 3 Months, 6 Months, 12 Months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• moderate or severe cognitive impairment
• severe untreated mental illness (e.g., schizophrenia, substance use disorder) that would interfere with providing meaningful consent/study participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Duke Cancer Institute — Durham

Публикации

• Dorfman CS, Arthur SS, Shelby RA, Stalls JM, Arrato NA, Somers TJ, Wu Y, Thomas SM, Willis MW, Youssef D, Divakaran S, Corbett C, Grilley-Olson J, Oeffinger KC. Symptom management and transitioning to engagement with post-treatment care for adolescent and young adult cancer survivors (AYA STEPS): Study protocol. Contemp Clin Trials. 2026 Jul 8:108391. doi: 10.1016/j.cct.2026.108391. Online ahead o PMID 42419501

Идентификаторы

NCT: NCT06371768 · Pro00115400 · 5R37CA283353-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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