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

January 26, 2026 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Cancer Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Caroline Dorfman, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain severity and interference as measured by Brief Pain Inventory
Time Frame: Baseline, 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.
Baseline, 3 Months, 6 Months, 12 Months
Fatigue as measured by PROMIS Fatigue Scale
Time Frame: Baseline, 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).
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
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).
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
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).
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
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).
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
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.
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
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.
Baseline, 3 Months, 6 Months, 12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The 6-item Self-Efficacy for Managing Chronic Illness Scale will be used to assess participants' current confidence in their ability to prevent symptoms (e.g., pain, fatigue, distress) from interfering with life. Responses are on a 10-point scale from "not at all confident" (1) to "totally confident" (10).
Baseline, 3 Months, 6 Months, 12 Months
Patient activation as measured by Patient Activation Measure (PAM)
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The PAM is a 13-item measure used to assess survivors' knowledge, skills, and confidence that are central to managing their health and health care. Patients are asked to rate their agreement with statements about their health and health care on a 4 point scale from "strongly disagree" to "strongly agree." From these response a total PAM score is calculated on a scale of 0-100, with higher scores indicating higher levels of activation.
Baseline, 3 Months, 6 Months, 12 Months
Patient self-efficacy for managing chronic conditions as measured by the PROMIS Self-Efficacy for Managing Symptoms Short Form
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The 4-item PROMIS Self-Efficacy for Managing Symptoms will be used to assess participants' confidence in their ability to manage symptoms (e.g. during daily activities, in a public place). Items are scored on a 5-point Likert scale, with higher scores indicating greater confidence.
Baseline, 3 Months, 6 Months, 12 Months
General patient self-efficacy as measured by the PROMIS General Self-Efficacy Short Form
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The 4-item PROMIS General Self-Efficacy will be used to assess participants' general confidence in their abilities (e.g., to solve problems and persist toward goals). Items are scored on a 5-point Likert scale, with higher scores indicating greater confidence.
Baseline, 3 Months, 6 Months, 12 Months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health care utilization: Chart Review
Time Frame: 12 Months
Health care utilization in the time since study enrollment will be assessed via review of participants' medical records to examine participants' receipt of general health screenings, cancer-related screenings, and follow-up care for late effects, in accordance with the 2024 National Comprehensive Cancer Network (NCCN) Adolescent and Young Adult (AYA) Guidelines.
12 Months
Area Deprivation Index (ADI)
Time Frame: Baseline
The ADI will be calculated using participants home mailing addresses. The ADI is an indexed composite of 17 variables related to social determinants of health from the United States Census and American Community Survey that captures socioeconomic disadvantage at the census block group level. The index is reported as a percentile from 0% to 100%, with higher scores indicating higher levels of deprivation.
Baseline
Health-care utilization: Self-report
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
Participants' self-reports of their health care utilization since study enrollment will be collected to enhance the study team's ability to obtain chart review data.
Baseline, 3 Months, 6 Months, 12 Months
Health literacy as measured by Medical Term Recognition Test (METER)
Time Frame: Baseline
The METER will be used to assess health literacy. Participants are asked to review a list of 40 words and check off those that they recognize as actual words.
Baseline
Participant experiences of discrimination as measured by Everyday Discrimination Scale-Short Form
Time Frame: Baseline
The Everyday Discrimination Scale-Short Form is a 5-item scale that assesses participants' subjective experiences of daily discrimination, with patients indicating the frequency of discrimination experiences on a 6-point scale from "never" to "almost everyday." Patients who respond that they have experienced discrimination more frequently than "never" are asked what they think is the main reason(s) they experience(d) discrimination (e.g. ancestry, gender, race).
Baseline
Participant evaluation of study mobile application as measured by User Version of the Mobile Application Rating Scale (uMARs)
Time Frame: 3 Months
The 20-item uMARs will be adapted to obtain participants' evaluation of the AYA STEPS digital health platform and the AYA Educational Information website. Participants are asked to respond to questions regarding the quality of the mobile application on a 5-point scale from "inadequate" (1) to "excellent" (5). A total quality score is calculated as the mean of four objective quality subscales (engagement, functionality, aesthetics, and information quality). The uMARs also includes a subjective quality subscale.
3 Months
Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
Time Frame: 3 Months
Participants will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the interventionists delivering either AYA STEPS or AYA Educational Information. The first 12 items ask participants to rate their agreement with statements related to intervention satisfaction on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" to "made things a lot worse."
3 Months
Web-based Portal Use as measured by total time using portal in minutes
Time Frame: Continuous (Baseline to 12 Months)
The AYA STEPS web-based portal and AYA Education Information website will track overall participant usage and content access for each of the respective sessions. The investigators will examine time spent accessing session content and time spent engaging in and completing home practice assignments.
Continuous (Baseline to 12 Months)
Symptom interference as measured by the Illness Intrusiveness Rating Scale
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The Illness Intrusiveness Rating Scale (IIRS) is a 13-item scale that assesses symptom interference across multiple life domains on a scale from 1 to 7, with higher scores indicating increased illness intrusiveness. The IIRS may be given a total sum score, or mean scores across three subscales: relationships and personal development, intimacy, and instrumental.
Baseline, 3 Months, 6 Months, 12 Months
Emotional support as measured by the PROMIS Emotional Support Short Form
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
Emotional support will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support Short Form, a 6-item measure assessing patients' perceived emotional support. Responses are on a 5-point scale from "never" (1) to "always" (5).
Baseline, 3 Months, 6 Months, 12 Months
Role functioning as measured by the 7-item role functioning subscale of the Functional Assessment of Cancer Therapy - General
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The 7-item functional well-being subscale of the Functional Assessment of Cancer Therapy - General (FACT-G) will assess the impact of cancer and cancer therapy on role functioning by evaluating participants' agreement with statements assessing functional well-being on a scale of 0 ("Not at all") to 4 ("Very much"). Higher scores indicate greater functional well-being.
Baseline, 3 Months, 6 Months, 12 Months
Spiritual well-being as measured by the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The 12-item Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale assesses spiritual well-being among patients with cancer. Participants report agreement with 12 statements assessing spiritual well-being on a scale of 0 ("Not at all") to 4 ("Very much"), with higher scores indicating greater spiritual well-being.
Baseline, 3 Months, 6 Months, 12 Months
Patient congruence of behaviors with values as measured by the Valuing Questionnaire
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The 10-item Valuing Questionnaire assesses congruence of behaviors with values by asking participants to rate their agreement with statements reflecting valued living on a scale of 0 ("Not at all true") to 6 ("Completely true"). Higher scores indicate higher congruence of behaviors with values.
Baseline, 3 Months, 6 Months, 12 Months
Psychological flexibility as measured by the Acceptance and Action Questionnaire for Cancer
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
The 18-item Acceptance and Action Questionnaire for Cancer (AAQ-C) assesses psychological flexibility by asking participants to rate their agreement with 18 statements evaluating their experiences as cancer survivors, on a scale of 1 ("Never true") to 7 ("Always true"). Lower scores indicate greater psychological flexibility.
Baseline, 3 Months, 6 Months, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00115400
  • 5R37CA283353-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is the investigators' intention to make all data generated from this proposal freely available after it is de-identified. All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Respondent identifiers will not be shared. All other scientific data (scale composites) will be both preserved and shared. The following data will be preserved and shared: patient-reported data from study assessments, intervention utilization data collected via the study websites, healthcare utilization data collected from the health record, socio-demographic and medical data collected via patient report and health record, and scores on social determinant of health assessments (e.g., Area Deprivation Index). The investigators will make every effort to provide raw data in a non-proprietary format wherever possible to enhance reproducibility.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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