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NCT05593016 · ClinicalTrials.gov registry record · NA
Adolescents and Young Adults (AYAs) With Advanced Cancer
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT05593016: Completed NA study, sponsored by Duke University.
NCT05593016 is a NA study that has completed, run by Duke University. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05593016, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged.
Interventions
- BEHAVIORAL Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)
- BEHAVIORAL Education Control Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2023-01-17 |
| Est. Completion | 2024-08-01 |
| Phase | NA |
What the finished NCT05593016 record still lists
NCT05593016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) is the first listed.
NCT05593016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05593016 about?
NCT05593016 is a clinical study titled "Adolescents and Young Adults (AYAs) With Advanced Cancer". 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 stra...
What is the current status of trial NCT05593016?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2023-01-17. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT05593016?
The interventions under investigation include: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) (BEHAVIORAL), Education Control Arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT05593016?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05593016's enrollment target sits among peer trials
75 1069th of 2000 higher than 919 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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