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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-14

Study Completion Date

2029-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Breast Cancer Colorectal Cancer Sarcoma Lymphoma Testicular Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

AYA STEPS

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

AYA Educational Information

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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 the 12 weeks of the AYA STEPS intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No