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Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Body Image Distress in Head and Neck Cancer Survivors (BRIGHT Trial)

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years on the day of informed consent

No planned significant HNC ablative or reconstructive surgery during the study intervention or follow-up period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

BRIGHT Trial Summary

This trial is testing whether or not a brief video tele-cognitive behavioral therapy intervention (BRIGHT) is more effective than a manualized tele-supportive care intervention (Attention Control) in reducing body image distress (BID) for head and neck cancer (HNC) survivors. The primary endpoint is the IMAGE-HN, a validated patient-reported outcome measure of HNC-related BID.

Who is the study for?

This trial is for adults over 18 who've had curative surgery for head and neck cancer within the last year, are now cancer-free, and experience significant body image distress. They must not be planning major surgeries during the study and should not have severe psychiatric issues or ongoing cognitive behavioral therapy.Check my eligibility

What is being tested?

The BRIGHT clinical trial tests a video tele-cognitive behavioral therapy against an Attention Control supportive care intervention to see which better helps with body image distress in head and neck cancer survivors.See study design

What are the potential side effects?

Since this trial involves psychological interventions rather than medications, traditional side effects are minimal. However, participants may experience emotional discomfort or increased awareness of their body image concerns.

BRIGHT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I don't have any major head or neck surgery planned during the study.

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I am currently free of cancer.

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I had surgery aimed at curing my cancer, with or without additional treatments or reconstruction.

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I have a confirmed diagnosis of squamous cell carcinoma.

BRIGHT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

IMAGE-HN

Secondary outcome measures

Automatic Thoughts Questionnaire

Feeling suicidal (finding)

Body Image Coping Strategies Inventory (BICSI)

+6 more

BRIGHT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BRIGHTExperimental Treatment1 Intervention

BRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist.

Group II: Attention ControlActive Control1 Intervention

The attention control arm is a manualized video tele-supportive care intervention that addresses non-body image aspects of HNC survivorship.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BRIGHT

2020

N/A

~60

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,435 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,463 Total Patients Enrolled

Media Library

BRIGHT (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05442957 — N/A

Head and Neck Cancers Research Study Groups: Attention Control, BRIGHT

Head and Neck Cancers Clinical Trial 2023: BRIGHT Highlights & Side Effects. Trial Name: NCT05442957 — N/A

BRIGHT (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05442957 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies in this clinical experiment?

"The information provided on clinicaltrials.gov indicates that this trial is not currently admitting new participants; the initial posting was seen on April 1st, 2023 and there have been no updates since June 29th, 2022. However, at present 587 other trials are actively searching for study subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT

Evan Graboyes 2023. "Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05442957.