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NCT05442957 · ClinicalTrials.gov registry record · NA
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
A NA study of Head and Neck Cancer and Mental Health Issue, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 5
- Study locations
NCT05442957: Recruiting NA study of Head and Neck Cancer and Mental Health Issue, sponsored by Medical University of South Carolina.
NCT05442957 is a NA study of Head and Neck Cancer and Mental Health Issue that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 180 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (31% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05442957, a NA study of Head and Neck Cancer and Mental Health Issue, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 5
- Study locations
Study Summary
In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure \[PROM\] of HNC-related body image distress \[BID\]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators).
Primary Outcome
The IMAGE-HN is a 24-item, validated patient-reported outcome measure (PROM) of HNC-related BID. Items are rated on a 5-point Likert scale from 'Never' (0) to 'Always' (4). The total global score is calculated by summing item responses across 21 items (all items except 3, 4, and 19). Total IMAGE-HN scores on the global domain (21 questions) range from 0-84; higher scores indicate worse HNC-related BID. An IMAGE-HN score of \> 22 indicates clinically-significant HNC-related BID and a change in IM
Conditions Studied
Interventions
- BEHAVIORAL Attention Control
- BEHAVIORAL BRIGHT
Study Locations (5)
Michigan
- Henry Ford Hospital - Detroit
Missouri
- Washington University in St. Louis - St Louis
Pennsylvania
- Pennsylvania State University - Hershey
South Carolina
- Medical University of South Carolina - Charleston
Texas
- University of Texas Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-02-14 |
| Est. Completion | 2027-03-30 |
| Phase | NA |
What NCT05442957 shows while recruiting
NCT05442957 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (31% lower).
The record links to 6 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which Attention Control is the first listed.
NCT05442957 lists 5 locations in 5 states (Michigan, Missouri, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05442957 about?
NCT05442957 is a clinical study titled "Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT". In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care i...
What is the current status of trial NCT05442957?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2023-02-14. Estimated completion is 2027-03-30.
What conditions does trial NCT05442957 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Mental Health Issue, Survivorship, Body Image, Body Image Disturbance.
What interventions are being tested in trial NCT05442957?
The interventions under investigation include: Attention Control (BEHAVIORAL), BRIGHT (BEHAVIORAL).
Who is sponsoring clinical trial NCT05442957?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05442957 being conducted?
This trial has 5 study locations across Michigan, Missouri, Pennsylvania, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05442957's enrollment target sits among peer trials
180 53rd of 250 higher than 198 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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