BRIGHT for Survival Rate (Survivorship)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Henry Ford Hospital, Detroit, MI
Survival Rate (Survivorship)+6 More
BRIGHT - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

In this multi-center randomized controlled 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).

Eligible Conditions

  • Survival Rate (Survivorship)
  • Psychosocial Impairment
  • Head and Neck Cancer
  • Body Image Disturbance
  • Image, Body
  • Mental Health Issue

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 6 months

6 months
Automatic Thoughts Questionnaire
Beck Scale for Suicidal Ideation
Body Image Coping Strategies Inventory (BICSI)
EORTC QLQ-HN35 Trouble with Social Contact Subscale
EORTC QLQ-Head Neck 35 Trouble with Social Eating Subscale
HADS-Anxiety
Hospital Anxiety and Depression Scale (HADS)-Depression
IMAGE-HN
PROMIS Short Form (SF) v2.0-Ability to Participate in Social Activities 8a
Shame and Stigma Scale-Head and Neck

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Attention Control
1 of 2
BRIGHT
1 of 2
Active Control
Experimental Treatment

180 Total Participants · 2 Treatment Groups

Primary Treatment: BRIGHT · No Placebo Group · N/A

BRIGHT
Behavioral
Experimental Group · 1 Intervention: BRIGHT · Intervention Types: Behavioral
Attention Control
Behavioral
ActiveComparator Group · 1 Intervention: Attention Control · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BRIGHT
2020
N/A
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Trial Background

Prof. Evan Graboyes, Associate Professor, Department of Otolaryngology- Head and Neck Surgery
Principal Investigator
Medical University of South Carolina
Closest Location: Henry Ford Hospital · Detroit, MI
Photo of Henry Ford Hospital  1Photo of Detroit  2Photo of Detroit  3
1993First Recorded Clinical Trial
2 TrialsResearching Survival Rate (Survivorship)
557 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had surgery for cancer of the breast, with or without adjuvant therapy, with or without reconstruction.
You have a score of 22 or higher on the IMAGE-HN score.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.