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

NCT ID: NCT05442957

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2027-03-30

Brief Summary

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).

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

BRIGHT

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

Group Type: EXPERIMENTAL

BRIGHT

Intervention Type: 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

The attention control arm is a manualized video tele-supportive care intervention that addresses non-body image aspects of HNC survivorship.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Evan Graboyes

Associate Professor, Department of Otolaryngology- Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Site Status: RECRUITING

Washington University in St. Louis

St Louis, Missouri, United States

Site Status: RECRUITING

Pennsylvania State University

Hershey, Pennsylvania, United States

Site Status: RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

University of Texas Southwestern

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evan M Graboyes, MD

Role: CONTACT

graboyes@musc.edu

843-792-0719

Taylor McLeod, MPH

Role: CONTACT

lowryta@musc.edu

Facility Contacts

Samantha Tam, MD

Role: primary

stam2@hfhs.org

313-916-2600

Patrik Pipkorn, MD, MSCI

Role: primary

ppipkorn@wustl.edu

314-362-8641

Neerav Goyal, MD, MPH, FACS

Role: primary

ngoyal1@pennstatehealth.psu.edu

717-531-8945

Evan M Graboyes, MD, MPH

Role: primary

graboyes@musc.edu

843-792-0719

Andrew Day, MD

Role: primary

Andrew.Day@UTSouthwestern.edu

References

Graboyes EM, Maurer SN, Kistner-Griffin E, Armeson K, Starr E, McLeod T, Balliet WE, Doenges J, Slavin-Spenny O, Vanderlan JR, Day A, Pipkorn P, Puram SV, Tam SH, Ruggiero KJ, Sterba KR. Protocol for a multisite, 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. Contemp Clin Trials. 2025 Jun;153:107888. doi: 10.1016/j.cct.2025.107888. Epub 2025 Mar 24.

Reference Type: DERIVED

PMID: 40139457 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R37CA269385

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO 00110248

Identifier Type: -

Identifier Source: org_study_id