- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05442957
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT (BRIGHT)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Evan M Graboyes, MD
- Phone Number: 843-792-0719
- Email: graboyes@musc.edu
Study Contact Backup
- Name: Taylor McLeod, MPH
- Email: lowryta@musc.edu
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
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Contact:
- Steven Chang, MD
- Phone Number: 313-916-2600
- Email: schang1@hfhs.org
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University in St. Louis
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Contact:
- Patrik Pipkorn, MD, MSCI
- Phone Number: 314-362-8641
- Email: ppipkorn@wustl.edu
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South Carolina
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Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
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Contact:
- Evan M Graboyes, MD, MPH
- Phone Number: 843-792-0719
- Email: graboyes@musc.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
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 write English
- 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
- Initiation or adjustment (< 3 months of baseline) of psychotropic medication
- Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BRIGHT
BRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IMAGE-HN
Time Frame: 9 months
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The IMAGE-HN is a 24-item, validated patient-reported outcome measure (PROM) of HNC-related BID.
Items are rated on a 5-point Likert scale from 'Never' (0) to 'Always' (4).
The total global score is calculated by summing item responses across 21 items (all items except 3, 4, and 19).
Total IMAGE-HN scores on the global domain (21 questions) range from 0-84; higher scores indicate worse HNC-related BID.
An IMAGE-HN score of > 22 indicates clinically-significant HNC-related BID and a change in IMAGE-HN score of > 9 points is clinically meaningful.
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9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shame and Stigma Scale-Head and Neck
Time Frame: 9 months
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The Shame and Stigma Scale is a 20-item, validated, unidimensional PROM that measures four domains (shame with appearance, stigma, regret, and social/speech concerns) in patients with HNC over the prior 7 days.
Items are rated on a 5-point Likert scale from 'Never' (0) to 'All the time' (4).
The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored).
Shame and Stigma Scale scores range from 0-80; higher scores reflect worse HNC-related shame and stigma.
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9 months
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PROMIS SF v1.0- Depression 8a
Time Frame: 9 months
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The PROMIS SF v1.0-Depression 8a is an 8-item validated measure developed by the NIH to assess patient-reported negative mood, views of self, and decreased positive affect and engagement.
Responses rate the strength of agreement with statements about depressive symptoms using a scale that ranges from 1-5.
The total raw score is calculated by summing the individual responses.
The PROMIS SF v1.0-Depression 8a raw score ranges from 8-40; a higher score reflects more severe depressive symptoms.
The PROMIS SF v1.0-Depression 8a total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual.
The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.
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9 months
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PROMIS SF v1.0-Anxiety 8a.
Time Frame: 9 months
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The PROMIS SF v1.0-Anxiety 8a is an 8-item, validated, developed by the NIH to assess patient-reported fear, worry, and hyperarousal.
Responses rate the strength of agreement with statements about anxiety symptoms using a scale that ranges from 1-5.
The total raw score is calculated by summing the individual responses.
The PROMIS SF v1.0-Anxiety 8a raw score ranges from 8-40; a higher score reflects more severe anxiety symptoms.
The PROMIS SF v1.0-Anxiety 8a total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual.
The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.
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9 months
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Beck Scale for Suicidal Ideation
Time Frame: 9 months
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The Beck Scale for Suicidal Ideation is a 21-item, validated, unidimensional rating scale that measures the current intensity of patients' specific attitudes, behaviors, and plans to commit suicide on the day of the interview.
Each item consists of three options graded according to suicidal intensity on a 3-point scale ranging from 0 to 2. The ratings for the first 19 items are summed to yield a total score, ranging from 0 to 38.
Higher scores represent more severe suicidal ideation.
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9 months
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PROMIS Short Form (SF) v2.0-Ability to Participate in Social Activities 8a
Time Frame: 9 months
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PROMIS SF v2.0-Ability to Participate in Social Activities 8a is an 8-item, validated, unidimensional measure of patient-reported perceptions of participation in social activities.
Items are scored using a 5-point Likert scale from 'Never' (1) to 'Always' (5).
The total raw score is calculated by summing the individual responses.
The total raw score ranges from 8-40; a higher score reflects more severe inability to participate in social activities.
The total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual.
The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.
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9 months
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EORTC QLQ-Head Neck 35 Trouble with Social Eating Subscale
Time Frame: 9 months
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The EORTC QLQ-Head Neck 35 Trouble with Social Eating Subscale is a 4-item, validated measure of trouble with social eating for patients with HNC.
The subscale is composed of QLQ-H&N35 items 19-22.
Items are scored using a 4-point Likert scale from 'not at all' (0) to 'very much' (3).
The total score is calculated by summing the individual responses.
Total subscale scores range from 0-12; higher scores reflect more trouble with social eating.
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9 months
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EORTC QLQ-HN35 Trouble with Social Contact Subscale
Time Frame: 9 months
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The EORTC QLQ-HN35 Trouble with Social Contact Subscale is a 5-item, validated measure of trouble with social contact for patients with HNC.
The subscale is composed of QLQ-H&N35 items 18, 25-28.
Items are scored using a 4-point Likert scale from 'not at all' (0) to 'very much' (3).
The total score is calculated by summing the individual responses.
Total subscale scores range from 0-15; higher scores reflect more trouble with social contact.
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9 months
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Body Image Coping Strategies Inventory (BICSI)
Time Frame: 9 months
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The BICSI is a 29-item, validated measure of the cognitive and behavioral responses to manage threats to body image.
BICSI contains three sub-domains; (1) appearance fixing (altering appearance by covering, camouflaging, or correcting the perceived defect), (2) avoidance (an attempt to escape or avert stressful body-image situations), and (3) positive rational acceptance (acceptance of the challenging event and positive self-care or rational self-talk about one's appearance).
Items are scored on a 4-point Likert scale from 'Definitely not like me' (0) to 'Definitely like me' (3).
The score for each subscale is calculated by summing the values for the individual questions and thus ranges as follows: Appearance fixing (0-30), Avoidance (0-24), and Positive rational acceptance (0-33).
For each subscale, higher scores indicate greater reliance on that type of body image coping strategy.
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9 months
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Automatic Thoughts Questionnaire
Time Frame: 9 months
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The Automatic Thoughts Questionnaire is a 15-item, validated, patient-reported measure of negative automatic thoughts.
Items are scored using a 5-point Likert scale (1-5).
The total score is calculated by summing the individual responses.
Total scores range from 15-75; higher scores reflect more negative automatic thoughts.
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9 months
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO 00110248
- R37CA269385 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Research materials will include baseline data and study outcomes from trial participants. Data will be raw or minimally processed.
Data will be available following final database lock, reporting to clinicaltrials.gov, and presentation and publication of study findings describing key primary and secondary objectives.
De-identified data available will be available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technology; and (3) a commitment to destroying or returning the data after analyses are completed. All data sharing will comply with laws, regulations, and policies privacy governing data derived from human subjects.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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