Recruiting

AYA STEPS

Sponsor:

Duke University

Code:

NCT06371768

Conditions

Cancer

Breast Cancer

Colorectal Cancer

Sarcoma

Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

AYA Educational Information

AYA STEPS

Study Details

Brief 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.

Conditions

Cancer

Breast Cancer

Colorectal Cancer

Sarcoma

Lymphoma

Study ID

NCT06371768

Start date

Jul 14, 2025

Status verified date

Jan, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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.

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.

Primary outcome measure

  • Pain severity and interference as measured by Brief Pain Inventory [ Time Frame: Baseline, 3 Months, 6 Months, 12 Months ]
  • Fatigue as measured by PROMIS Fatigue Scale [ Time Frame: Baseline, 3 Months, 6 Months, 12 Months ]
  • Emotional distress as measured by PROMIS Depression Short Form [ Time Frame: Baseline, 3 Months, 6 Months, 12 Months ]
  • Emotional distress as measured by PROMIS Anxiety Short Form [ Time Frame: Baseline, 3 Months, 6 Months, 12 Months ]
  • Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference [ Time Frame: Baseline, 3 Months, 6 Months, 12 Months ]
  • Health care engagement as measured by Patient Participation Questionnaire [ Time Frame: 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 [ Time Frame: Baseline, 3 Months, 6 Months, 12 Months ]

Central Contacts and Locations

Central contacts

Caroline S Dorfman, PhD

919-416-3473caroline.dorfman@duke.edu

Locations

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Michael W Willis

919-681-8437michael.w.willis@duke.edu

Smrithi Divakaran, MPH

919-681-7695smrithi.divakaran@duke.edu

Principal Investigator:

Caroline Dorfman, PhD

More Information

Sponsor

Duke University

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • Cancer
  • Young Adult
  • Behavioral Symptom Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-28.