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

Purpose

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).

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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) 1. Patients who complete definitive HNC-directed therapy (e.g., surgery or radiation therapy) but are on adjuvant immunotherapy are considered eligible 2. Oncologic treatment refers to cancer-directed therapy; non-cancer surgery (e.g., trachea-esophageal puncture, flap debulking, etc) are not relevant for the purposes of determining eligibility vis a vis completing oncologic treatment within 6-week to 12 months of enrollment 5. Cancer-free at the time of accrual -patients with known indolent malignancies (e.g., non-melanoma skin cancer, low risk thyroid cancer, untreated prostate cancer, etc) would not exclude a patient from the study 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

Exclusion Criteria

  1. Inability to speak or read English 2. Pre-existing, ongoing psychotherapy services for any disorder and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial 3. Severe mental illness that would prevent trial participation

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BRIGHT 		BRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist.
  • 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.
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.
  • 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.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63110
Contact:
Patrik Pipkorn, MD, MSCI
314-362-8641
ppipkorn@wustl.edu

More Details

NCT ID
NCT05442957
Status
Recruiting
Sponsor
Medical University of South Carolina

Study Contact

Evan M Graboyes, MD
843-792-0719
graboyes@musc.edu

Detailed Description

We will perform a multi-site randomized clinical trial (RCT) comparing BRIGHT with AC to test our hypotheses that BRIGHT reduces BID and improves psychological and social well-being and QOL at 2, 3, 6, and 9-months post-randomization by enhancing body image coping skills and decreasing unhelpful automatic thoughts. HNC survivors with clinically significant BID (N=180) from multiple sites in the United States will be randomized 1:1 to BRIGHT or AC. We will conduct semi-structured interviews with key stakeholders (n=10/site) and in-depth site visits to assess barriers and facilitators of the adoption of BRIGHT and develop an implementation toolkit to enhance the future adoption of BRIGHT into routine clinical care.