Clinical trial NCT06371768: Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors
Official title: Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Breast Cancer
Colorectal Cancer
Sarcoma
Lymphoma
Testicular Cancer
Keywords: Cancer
Young Adult
Behavioral Symptom Management
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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) 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

Primary outcomes:
measure: Pain severity and interference as measured by Brief Pain Inventory
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Fatigue as measured by PROMIS Fatigue Scale
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Emotional distress as measured by PROMIS Depression Short Form
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Emotional distress as measured by PROMIS Anxiety Short Form
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Health care engagement as measured by Patient Participation Questionnaire
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
Secondary outcomes:
measure: Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Patient activation as measured by Patient Activation Measure (PAM)
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
Other outcomes:
measure: Health care utilization: Chart Review
timeFrame: 12 Months
measure: Area Deprivation Index (ADI)
timeFrame: Baseline
measure: Health-care utilization: Self-report
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Health literacy as measured by Medical Term Recognition Test (METER)
timeFrame: Baseline
measure: Participant experiences of discrimination as measured by Everyday Discrimination Scale-Short Form
timeFrame: Baseline
measure: Participant evaluation of study mobile application as measured by User Version of the Mobile Application Rating Scale (uMARs)
timeFrame: 3 Months
measure: Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
timeFrame: 3 Months
measure: Web-based Portal Use as measured by total time using portal in minutes
timeFrame: Continuous (Baseline to 12 Months)
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
References: