RECRUITING

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

Conditions

Head and Neck Cancer Body Image Disturbance Body Image Survivorship Psychosocial Impairment Mental Health Issue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Multi-Site, Parallel-Group, Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) With Attention Control for the Reduction of Body Image-Related Distress Among Head and Neck Cancer Survivors

Quick Facts

Study Start:2023-02-14

Study Completion:2027-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05442957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age \> 18 years on the day of informed consent 2. History of pathologically confirmed squamous cell carcinoma (or histologic variant) of the oral cavity, pharynx, larynx, nose/paranasal sinuses, carcinoma of a major or minor salivary gland, or cutaneous malignancy of the face or neck 3. History of curative intent surgery with or without adjuvant therapy, with or without reconstruction 4. Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion) 5. Cancer-free at the time of accrual 6. No planned significant HNC ablative or reconstructive surgery (defined by a postoperative inpatient stay of at least three days) during the study intervention or follow-up period as determined by the HNC oncologic surgeon at the time of study accrual 7. Willingness to be randomized to either BRIGHT or AC 8. IMAGE-HN score \> 22	1. Inability to speak or write English 2. Pre-existing, ongoing CBT services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial 3. Initiation or adjustment (\< 3 months of baseline) of psychotropic medication 4. Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)

Inclusion Criteria

Exclusion Criteria

1. Age \> 18 years on the day of informed consent
2. History of pathologically confirmed squamous cell carcinoma (or histologic variant) of the oral cavity, pharynx, larynx, nose/paranasal sinuses, carcinoma of a major or minor salivary gland, or cutaneous malignancy of the face or neck
3. History of curative intent surgery with or without adjuvant therapy, with or without reconstruction
4. Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)
5. Cancer-free at the time of accrual
6. No planned significant HNC ablative or reconstructive surgery (defined by a postoperative inpatient stay of at least three days) during the study intervention or follow-up period as determined by the HNC oncologic surgeon at the time of study accrual
7. Willingness to be randomized to either BRIGHT or AC
8. IMAGE-HN score \> 22

1. Inability to speak or write English
2. Pre-existing, ongoing CBT services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial
3. Initiation or adjustment (\< 3 months of baseline) of psychotropic medication
4. Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)

Contacts and Locations

Study Contact

Evan M Graboyes, MD

CONTACT

843-792-0719

graboyes@musc.edu

Taylor McLeod, MPH

CONTACT

lowryta@musc.edu

Study Locations (Sites)

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Washington University in St. Louis

Saint Louis, Missouri, 63110

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

University of Texas Southwestern

Dallas, Texas, 75235

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-14

Study Completion Date2027-03-30

Study Record Updates

Study Start Date2023-02-14

Study Completion Date2027-03-30

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Cancer
Body Image Disturbance
Body Image
Survivorship
Psychosocial Impairment
Mental Health Issue