AYA STEPS for Cancer Survivors

(AYA STEPS Trial)

Overseen By Caroline S Dorfman, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Endocrine therapy

Disqualifiers: Cognitive impairment, Untreated mental illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital health program called AYA STEPS to determine its effectiveness in helping adolescent and young adult cancer survivors manage symptoms and maintain follow-up care. Participants will either engage with AYA STEPS, which includes six online sessions with a psychologist, or join an educational program with a similar format. It suits individuals who have completed treatment for stage I-III breast, colorectal, sarcoma, Hodgkin or non-Hodgkin lymphoma, or stage I-II testicular cancer (excluding some ongoing therapies) within the last three months to five years. Participants should be comfortable using English and able to consent to the trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance long-term care for cancer survivors.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you can continue taking endocrine/hormonal therapy or oral targeted therapies if they are used to prevent cancer recurrence or progression.

What prior data suggests that the AYA STEPS program is safe for adolescent and young adult cancer survivors?

Research has shown that digital health programs like AYA STEPS are generally safe for young cancer survivors. A review of similar digital tools found that users usually handle them well and rarely report serious problems.

In a small study of a similar digital program, participants used it without major issues, and no serious side effects were noted. This suggests that AYA STEPS is likely safe for most users.

Since AYA STEPS is not a physical drug, the risks are lower compared to traditional treatments. Overall, digital health programs have a good track record in helping young cancer survivors manage symptoms and improve their health habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AYA STEPS because it offers a unique digital health approach for cancer survivors. Unlike traditional therapies that may require in-person visits, AYA STEPS is delivered entirely through videoconferencing, making support more accessible and convenient. This program focuses on mental health and well-being, providing personalized sessions with a clinical psychologist that can be accessed from anywhere with an internet connection. By using a web-based platform, AYA STEPS aims to empower young adult cancer survivors with tools to manage their emotional health effectively, potentially leading to better long-term outcomes.

What evidence suggests that the AYA STEPS program is effective for cancer survivors?

Research has shown that digital health programs can benefit young cancer survivors by managing symptoms and supporting follow-up care. In this trial, participants will receive either the AYA STEPS digital health intervention or an education control condition. Early results suggest that programs like AYA STEPS might encourage healthy habits and improve mental well-being. The aim is to help young cancer survivors take better care of their health and remain engaged in their treatment. Although limited data exists specifically on AYA STEPS, similar digital programs have shown promise in this area. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for young adults who are 1-5 years post-diagnosis of stage I-III breast, colorectal, sarcoma, Hodgkin or non-Hodgkin lymphoma, or stage I-II testicular cancer. Participants must speak English and be able to consent. They should be off therapy except hormonal treatments for at least three months.

Inclusion Criteria

I understand the study and can agree to participate.

I can speak and read English.

I have been diagnosed with early to mid-stage breast, colorectal, sarcoma, lymphoma, or testicular cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AYA STEPS digital health intervention or educational information over six biweekly sessions

12 weeks

6 sessions (remote)

Follow-up

Participants are monitored for symptom management and health care engagement

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AYA Educational Information
• AYA STEPS

Trial Overview The study tests AYA STEPS, a digital health program aimed at helping survivors manage symptoms and transition into follow-up care after treatment. It also looks at the impact of providing educational information tailored to these individuals.

How Is the Trial Designed?

Group I: AYA STEPS Experimental Treatment 1 Intervention

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 II: Education Control Active Control 1 Intervention

The education control condition will match AYA STEPS in delivery format \[videoconferencing, web-based platform, frequency (biweekly sessions)\], and session number (six) and length.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6547376/

Digital Health Interventions for Adolescent and Young ... This narrative review describes the evidence regarding digital health interventions targeting adolescent and young adult (AYA) cancer survivors.

2. bmcdigitalhealth.biomedcentral.com bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00064-1

a randomized controlled pilot trial | BMC Digital Health Conclusions. The PREVENT digital intervention may provide improvements in preventive behaviors among AYA cancer survivors by supporting care ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06371768

Symptom Management and Transitioning to Engagement ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6693302/

Digital Interventions to Support Adolescents and Young ... A recent narrative review of digital health interventions targeting AYA cancer survivors demonstrated the range of digital modalities used to support young ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003665

Design and methods of the EMPOWER full factorial trial Upon trial completion, we will have an optimized, digital health intervention to enhance psychological well-being among AYA cancer survivors. EMPOWER will ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003288

INteractive survivorship program to improve health care ... The intervention includes an interactive mobile app, study website, and social media platforms, adding telehealth for those with continued distress, lower ...