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NCT05442957 | RECRUITING | Head and Neck Cancer

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

Medical University of South Carolina

Information provided by (Responsible Party):

Evan Graboyes

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).

Condition or disease

Head and Neck Cancer

Body Image Disturbance

Body Image

Survivorship

Psychosocial Impairment

Mental Health Issue

Intervention/treatment

BRIGHT

Attention Control

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2023-02-14
Estimated Primary Completion Date : 2027-01-30
Estimated Study Completion Date : 2027-03-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
  • 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 write English
  • 2. Pre-existing, ongoing CBT services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial
  • 3. Initiation or adjustment (\< 3 months of baseline) of psychotropic medication
  • 4. Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT

Location Details

NCT05442957

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

Henry Ford Hospital

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Missouri

Washington University in St. Louis

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

NOT YET RECRUITING

United States, Texas

University of Texas Southwestern

Dallas, Texas, United States, 75235