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Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0

NCT03831100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-08-09

Study results available
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Summary

Head and neck cancer (HNC) survivors with body image-related distress (BID) will be randomized to 5-weeks of tablet-based BRIGHT or tablet-based active control (AC; electronic information about HNC recovery). Participants will complete validated measures of BID and psychological, social, and emotional wellbeing to assess the preliminary clinical impact of BRIGHT on BID in HNC survivors. Participants will also complete validated measures of body image coping behavior to assess the role of image coping behavior as the behavioral mechanism of BRIGHT.

Conditions

Interventions

BEHAVIORAL

BRIGHT

The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT.

BEHAVIORAL

Active Control

AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session (Table 5) is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Evan M Graboyes, MD, MPH · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-02-22
Completion
2022-04-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831100 on ClinicalTrials.gov