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NCT05811936 · ClinicalTrials.gov registry record · NA
The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads
A NA study of Head and Neck Cancer and Caregiver Burden, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 352
- Enrollment target
- 1
- Study location
NCT05811936: Recruiting NA study of Head and Neck Cancer and Caregiver Burden, sponsored by Medical University of South Carolina.
NCT05811936 is a NA study of Head and Neck Cancer and Caregiver Burden that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 352 participants, above the 259-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (36% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05811936, a NA study of Head and Neck Cancer and Caregiver Burden, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 352 participants
- Enrollment target
- 1
- Study location
Study Summary
In this randomized behavioral intervention, head and neck cancer (HNC) survivors and their caregivers (N=176 HNC survivor-caregiver dyads) will be randomized to either Survivorship Needs Assessment Planning (SNAP) or Usual Care (UC) groups to examine the effects of SNAP on outcomes. SNAP includes two sessions with a needs assessment and tailored care plan and a supportive mobile app after completion of radiation to promote uptake of recommended medical and supportive care. The study aims to evaluate the effects of SNAP on symptom severity in patients and caregiver burden in caregivers. Secondary outcomes include psychological distress (anxiety and depression), healthcare utilization (receipt of recommended care) and unmet needs and self-efficacy in HNC survivor-caregiver dyads. Participants will complete surveys at baseline, 6 months, and 9 months post randomization with validated PROMs, and receive intervention modules at the end of radiation and month 3. Participants in the SNAP group will also receive mobile app support.
Primary Outcome
Caregivers report the extent to which caregiving impacts time, responsibilities, and strain utilizing the Zarit Burden Inventory. Caregivers rate each item on a 5-point Likert scale (0=Never to 4=Always); higher scores (0-16) indicate greater burden. An increase in change from baseline to 6 week, 6 months or 9 months follow up visit would increased caregiver distress; likewise a decrease in change would indicate reduced caregiver distress. Cronbach's alphas in previous research range from 0.81-0
Conditions Studied
Interventions
- BEHAVIORAL Survivorship Needs Assessment Planning (SNAP) tool
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2023-08-23 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What NCT05811936 shows while recruiting
NCT05811936 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, above the 259-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (36% higher).
The record links to 4 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Survivorship Needs Assessment Planning (SNAP) tool is the first listed.
NCT05811936 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT05811936 about?
NCT05811936 is a clinical study titled "The SNAP Tool for Head and Neck Cancer Survivor-Caregiver Dyads". In this randomized behavioral intervention, head and neck cancer (HNC) survivors and their caregivers (N=176 HNC survivor-caregiver dyads) will be randomized to either Survivorship Needs Assessment Planning (SNAP) or Usual Care (UC) groups to examine the effects of SNAP on outcomes. SNAP includes tw...
What is the current status of trial NCT05811936?
This trial is currently recruiting. It is a NA study. The enrollment target is 352 participants. The study started on 2023-08-23. Estimated completion is 2026-05-31.
What conditions does trial NCT05811936 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Caregiver Burden, Survivorship, Head and Neck Neoplasms.
What interventions are being tested in trial NCT05811936?
The interventions under investigation include: Survivorship Needs Assessment Planning (SNAP) tool (BEHAVIORAL).
Who is sponsoring clinical trial NCT05811936?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05811936 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05811936's enrollment target sits among peer trials
352 27th of 250 higher than 223 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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