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

NCT06371768 | Recruiting DMC

• 2 other identifiers: Pro001154005R37CA283353-02
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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; Sarcoma; Breast Cancer; Colorectal Cancer; Lymphoma; Testicular Cancer

Keywords

Cancer; Young Adult; Behavioral Symptom Management

Outcome Measures

Primary Outcomes (7)

• Pain severity and interference as measured by Brief Pain Inventory

  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

  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

  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

• Emotional distress as measured by PROMIS Anxiety Short Form

  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

• Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference

  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

• Health care engagement as measured by Patient Participation Questionnaire

  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

  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 Outcomes (4)

• Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale

  Baseline, 3 Months, 6 Months, 12 Months

• Patient activation as measured by Patient Activation Measure (PAM)

  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

  Baseline, 3 Months, 6 Months, 12 Months

• General patient self-efficacy as measured by the PROMIS General Self-Efficacy Short Form

  Baseline, 3 Months, 6 Months, 12 Months

Other Outcomes (14)

• Health care utilization: Chart Review

  12 Months

• Area Deprivation Index (ADI)

  Baseline

• Health-care utilization: Self-report

  Baseline, 3 Months, 6 Months, 12 Months

Study Arms (2)

Education Control

ACTIVE COMPARATOR

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 STEPS

EXPERIMENTAL

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

Interventions

AYA Educational Information BEHAVIORAL

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.

Education Control

AYA STEPS BEHAVIORAL

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.

AYA STEPS

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 5 years post-diagnosis
• Able to speak and read English
• Able to give informed consent

You may not qualify if:

• moderate or severe cognitive impairment
• severe untreated mental illness (e.g., schizophrenia, substance use disorder) that would interfere with providing meaningful consent/study participation

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Sarcoma; Lymphoma; Testicular Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Central Study Contacts

Caroline S Dorfman, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: July 14, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)