AYA STEPS for Symptom Management in Young Adult Cancer Survivors

This study is testing a digital health program called AYA STEPS, which aims to help young adult cancer survivors manage their symptoms and stay engaged with their follow-up medical care. You might be able to join if you are between 18 and 39 years old and have been diagnosed with certain types of cancer, including breast, colorectal, sarcoma, or lymphoma, and have finished your main cancer treatment. The study will compare AYA STEPS to general educational information. Success will be measured by improvements in pain, fatigue, and emotional distress over 12 months. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 260 participants. It will compare the AYA STEPS program to AYA Educational Information.
What's involved
You would participate in six sessions with a clinical psychologist, delivered via video conferencing. Your symptoms will be measured at baseline, 3, 6, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be monitored for 12 months after starting the study.

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NCT06371768

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

Recruiting
NAAges 18–39InterventionalSupportive care
Duke University
~260 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:AYA Educational InformationAYA STEPS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain severity and interference as measured by Brief Pain Inventory
Measured over Baseline, 3 Months, 6 Months, 12 Months
+6 more outcomes measured
Cancer
Breast Cancer
Colorectal Cancer
Sarcoma
Lymphoma
Testicular Cancer
1 sites across 1 states
North Carolina1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

moderate or severe cognitive impairment
severe untreated mental illness (e.g., schizophrenia, substance use disorder) that would interfere with providing meaningful consent/study participation
  • Pain severity and interference as measured by Brief Pain InventoryBaseline, 3 Months, 6 Months, 12 Months

    The Brief Pain Inventory will be used to assess pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). This measures includes a body map on which the patient can mark the location(s) in which they are experiencing pain, as well as 8 questions on a scale of 0 to 10 with higher scores indicating worse pain severity or pain interference.

  • Fatigue as measured by PROMIS Fatigue ScaleBaseline, 3 Months, 6 Months, 12 Months

    Fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"), providing ratings on a scale from "not at all" (1) to "very much" (5).

  • Emotional distress as measured by PROMIS Depression Short FormBaseline, 3 Months, 6 Months, 12 Months

    Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).

  • Emotional distress as measured by PROMIS Anxiety Short FormBaseline, 3 Months, 6 Months, 12 Months

    Symptoms of Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).

  • Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom InterferenceBaseline, 3 Months, 6 Months, 12 Months

    The MDASI will be used to assess interference of symptoms in daily living (e.g., working, relations with other people, enjoyment of life) over the past month. The MDASI asks patients to rate the severity of 13 symptoms found frequently in patients with various cancers and treatment types on a scale from 0 (symptom "not present") to 10 (symptom "as bad as you can imagine"). This measure also includes 6 questions asking patients to rate the level of symptom interference in six domains (e.g., general activity, mood) on a scale from 0 (did not interfere) to 10 (interfered completely).

  • Health care engagement as measured by Patient Participation QuestionnaireBaseline, 3 Months, 6 Months, 12 Months

    The Patient Participation Questionnaire will be used to assess participants' health care participation and associated domains (i.e., receipt of information, communication, perceptions of their relationship with the medical team). Participants are asked to indicate their agreement with 17 items related to health care engagement on a 4 point scale: "to a great extent," "to some extent," "to a lesser extent," or "not at all." An additional item asks patients about their overall assessment of their involvement in their healthcare.

  • Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscaleBaseline, 3 Months, 6 Months, 12 Months

    The MCCS patient subscale will be used to assess survivors' perceptions of their competency for communicating and participating in health care. The patient subscale includes 39 items on a scale of 1 to 7, with higher scores reflecting self-perception of better medical communication competence.