Adolescents and Young Adults (AYAs) With Advanced Cancer
Public ClinicalTrials.gov record NCT05593016. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Improving Symptom Management for Adolescents and Young Adults With Advanced Cancer: Development and Pilot Testing of a Novel Intervention
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study aims to develop and test the feasibility and acceptability of a psychosocial symptom management intervention designed to meet the unique needs of Adolescents and Young Adults (AYAs) with advanced cancer. The proposed intervention will combine traditional behavioral symptom management strategies commonly use in the palliative care setting with important skills and concepts from Meaning-Centered Psychotherapy and Acceptance and Commitment Therapy. Skills from these approaches may be particularly relevant to AYAs with advanced cancer who experience significant disruption in life goals from cancer and associated symptoms and may have greater difficulties understanding and finding meaning in their lives than older and younger patients. Intervention content, structure, and study procedures will be informed by qualitative data obtained during interviews/focus groups with patient (n=16) and caregiver (n=12) stakeholders as well as review by patient user testers (n=3). It is anticipated that the intervention will include four weekly sessions spaced over 6-8 weeks and be delivered using videoconferencing. Next, AYAs with advanced cancer (N=40) will be randomized to the intervention or education control arms using an allocation ratio of 1.5: 1. The study team will examine the feasibility of study recruitment and retention, acceptability, and changes in variables of interest (i.e., physical and psychological symptoms, symptom interference, self-efficacy for symptom management, experiential avoidance, values) over time for the intervention and control arms. Participants will also provide feedback on study materials, intervention format, and the appropriateness of the intervention to the population and advanced stage of disease.
Study identification
- NCT ID
- NCT05593016
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Interventions
- Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) Behavioral
- Education Control Arm Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 15 Years to 29 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 16, 2023
- Primary completion
- Jul 29, 2024
- Completion
- Jul 31, 2024
- Last update posted
- Nov 2, 2025
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke Cancer Institute | Durham | North Carolina | 27701 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05593016, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05593016 live on ClinicalTrials.gov.