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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BRIGHT — BEHAVIORAL
  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.
• Attention Control — BEHAVIORAL
  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.

Study Details

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).

Key Dates

Start date

Feb 14, 2023

Status verified

Sep 2025

Primary completion

Jan 30, 2027

Completion

Mar 30, 2027

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: BRIGHT
  BRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist.
• Active Comparator: Attention Control
  The attention control arm is a manualized video tele-supportive care intervention that addresses non-body image aspects of HNC survivorship.

Primary Outcome Measure

IMAGE-HN [ Time Frame: 9 months ]

Central Contacts

• Evan M Graboyes, MD
  843-792-0719
  [email protected]
• Taylor McLeod, MPH
  [email protected]

Locations (5)

Find similar trials in Detroit, MI

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