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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 is a NA study that has completed, run by Duke University. The registered enrollment target is 75 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05593016
The ClinicalTrials.gov registry entry for NCT05593016 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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