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

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 14, 2023

Primary Completion Date

January 30, 2027

Study Completion Date

March 30, 2027

Conditions
Head and Neck CancerBody Image DisturbanceBody ImageSurvivorshipPsychosocial ImpairmentMental Health Issue
Interventions
BEHAVIORAL

BRIGHT

BRIGHT is a manualized theory-based tele-CBT intervention consisting of 6 weekly 60-minute sessions. BRIGHT is delivered one-on-one by a licensed clinical psychologist at each site via standard video tele-CBT platform. BRIGHT session topics include (1) psychoeducation about the cognitive model of body image, (2) self-monitoring about thoughts, feelings, and body image behaviors, (3) cognitive restructuring to identify and challenge unhelpful automatic HNC body image thoughts, (4) positive body image coping strategies, (5) social support and identifying personal value, and (6) thinking ahead and planning for setbacks.

BEHAVIORAL

Attention Control

AC is a manualized video-tele-supportive care intervention that addresses non-body image aspects of HNC survivorship. Identical to BRIGHT, AC consists of 6 weekly 60-minute sessions delivered by a trained empathic interventionist via standard video-telemedicine platform. AC session topics include (1) Introduction to HNC survivorship, (2) Post-Treatment Side Effects (3) Psychosocial Aspects of HNC, (4) Health Promotion and Nutritional Challenges, (5) Financial Distress and Return to Work, and (6) Cancer Recurrence. AC controls for professional attention (i.e., ensuring that findings are not driven by simply interacting with an empathic interventionist), common factors, dose, and delivery method while not providing the active, behavior change mechanism in BRIGHT.

Trial Locations (5)

16802

RECRUITING

Pennsylvania State University, Hershey

29425

RECRUITING

Medical University of South Carolina, Charleston

48202

RECRUITING

Henry Ford Hospital, Detroit

63110

RECRUITING

Washington University in St. Louis, St Louis

75235

RECRUITING

University of Texas Southwestern, Dallas

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Medical University of South Carolina

OTHER