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

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+