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

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

NCT ID: NCT06371768

Condition: Cancer
Breast Cancer
Colorectal Cancer
Sarcoma
Lymphoma
Testicular Cancer

Conditions: Official terms:
Testicular Neoplasms

Conditions: Keywords:
Cancer
Young Adult
Behavioral Symptom Management

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: AYA Educational Information
Description: 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.
Arm group label: Education Control

Intervention type: Behavioral
Intervention name: AYA STEPS
Description: 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.
Arm group label: AYA STEPS

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.

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.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: 39 Years

Healthy volunteers: No

Start date: April 1, 2025

Completion date: June 30, 2029

Lead sponsor:
Agency: Duke University
Agency class: Other

Source: Duke University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06371768