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

Official title

A Multi-Site, 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

Overview

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.

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 i
• 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)

Primary outcome measures

• IMAGE-HN [Time frame: 9 months]

Secondary outcome measures (9)

• Shame and Stigma Scale-Head and Neck [Time frame: 9 months]
• PROMIS SF v1.0- Depression 8a [Time frame: 9 months]
• PROMIS SF v1.0-Anxiety 8a. [Time frame: 9 months]
• Beck Scale for Suicidal Ideation [Time frame: 9 months]
• PROMIS Short Form (SF) v2.0-Ability to Participate in Social Activities 8a [Time frame: 9 months]
• EORTC QLQ-Head Neck 35 Trouble with Social Eating Subscale [Time frame: 9 months]
• EORTC QLQ-HN35 Trouble with Social Contact Subscale [Time frame: 9 months]
• Body Image Coping Strategies Inventory (BICSI) [Time frame: 9 months]
• Automatic Thoughts Questionnaire [Time frame: 9 months]

Eligibility criteria

Inclusion criteria

• Age > 18 years on the day of informed consent
• 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
• History of curative intent surgery with or without adjuvant therapy, with or without reconstruction
• Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)

• Patients who complete definitive HNC-directed therapy (e.g., surgery or radiation therapy) but are on adjuvant immunotherapy are considered eligible
• 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
• 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

• 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
• Willingness to be randomized to either BRIGHT or AC
• IMAGE-HN score ≥ 22

Exclusion criteria

• Inability to speak or read English
• 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
• Severe mental illness that would prevent trial participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 5 centers

• Henry Ford Hospital — Detroit
• Washington University in St. Louis — St Louis
• Pennsylvania State University — Hershey
• Medical University of South Carolina — Charleston
• University of Texas Southwestern — Dallas

Publications

• 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 PMID 40139457

Identifiers

NCT: NCT05442957 · PRO 00110248 · R37CA269385

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗