An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) Compared to Attention Control for the Reduction of Body Image-Related Distress among Head and Neck Cancer Survivors
Trial Status: active
This clinical trial compares the effect of the Building a Renewed ImaGe after Head & neck cancer Treatment (BRIGHT) intervention to attention control in reduction of body image-related distress among head and neck cancer survivors. Head and neck cancer can result in disfigurement, difficulty swallowing, impaired smiling, and challenges speaking. As a result, head and neck cancer survivors express body image concerns and can even experience body image-related distress (BID). BID is a source of devastating psychosocial despair and functional impairment for head and neck survivors, contributing to an increase in depression, high rates of social isolation, and decreased quality of life. BRIGHT is a video telemedicine (tele)-based cognitive behavioral therapy, a type of psychotherapy that involves the identification of unhelpful or destructive patterns of thinking and behaviors and the subsequent replacement with behaviors that are beneficial and constructive. This study may help researchers determine whether video telemedicine-based cognitive behavioral therapy is an effective treatment for body image concerns among head and neck cancer survivors.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05442957.
I. To evaluate the efficacy of BRIGHT compared with attention control (AC) on head and neck cancer (HNC)-related BID as measured by change from baseline in the Inventory to Measure and Assess imaGe disturbancE-Head & Neck (IMAGE-HN) score.
SECONDARY OBJECTIVES:
I. To evaluate the clinical response rate of BRIGHT compared with AC on HNC-related BID as measured by proportion of patients with a clinically meaningful change from baseline in the IMAGE-HN score.
II. To further evaluate the short and longer-term efficacy of BRIGHT compared with AC on HNC-related BID as measured by change from baseline in the IMAGE-HN score.
III. To evaluate the efficacy of BRIGHT compared with AC on psychological and social well-being as measured by change from baseline in the Shame and Stigma Scale in HNC, Patient-Reported Outcome Measurement Inventory System (PROMIS) Short Form (SF) version (v)1.0-Depression 8a, PROMIS SF v1.0-Anxiety 8a, and PROMIS SF v2.0-Ability to Participate in Social Activities-8a scores.
IV. To evaluate the efficacy of BRIGHT compared with AC on quality of life (QOL) as measured by change from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of LIfe Questionnaire (QLQ)-Head and Neck (HN)35 score.
V. To examine the mechanism of change underlying BRIGHT for HNC-related BID as measured by change from baseline in the Body Image Coping Strategies Inventory (BICSI) subscale scores and Automatic Thoughts Questionnaire scores.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo BRIGHT intervention consisting of cognitive behavioral therapy with a mental health professional via telemedicine over 1 hour once a week (QW) for 6 weeks on study. Additionally, patients may participate in an interview on study.
GROUP II: Patients receive attention control consisting of survivorship education from head and neck cancer clinician via telemedicine over 1 hour QW for 6 weeks on study. Additionally, patients may participate in an interview on study.
After completion of study intervention, patients are followed up at 2, 3, 6, and 9 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMedical University of South Carolina
