Head and Neck CancerBRIGHTNCT05442957
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
A study testing BRIGHT in people with Head and Neck Cancer and Body Image Disturbance, run by Medical University of South Carolina at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Body Image Disturbance, Body Image
- What is being tested?
- BRIGHT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Feb 2023to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taylor McLeod, MPH contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Evan M Graboyes, MD, MPH, 843-792-0719, graboyes@musc.edu
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75235
Andrew Day, MD, Andrew.Day@UTSouthwestern.edu
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Samantha Tam, MD, (313) 916-2600, stam2@hfhs.org
- Recruiting
Pennsylvania State University
Hershey, Pennsylvania, 16802
Neerav Goyal, MD, MPH, FACS, 717-531-8945, ngoyal1@pennstatehealth.psu.edu
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Patrik Pipkorn, MD, MSCI, 314 362 8641, ppipkorn@wustl.edu
About this study
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
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).
Read the 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
- Being tested
- BRIGHT, Attention Control
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIGHTBehavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BRIGHT | Experimental | BRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist. Receives: Behavioral: BRIGHT |
| Attention Control | Active comparator | The attention control arm is a manualized video tele-supportive care intervention that addresses non-body image aspects of HNC survivorship. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMAGE-HN
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.
Measured: 9 months
Secondary outcomes (9)
Shame and Stigma Scale-Head and Neck
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.
Measured: 9 months
PROMIS SF v1.0- Depression 8a
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.
Measured: 9 months
PROMIS SF v1.0-Anxiety 8a.
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.
Measured: 9 months
Beck Scale for Suicidal Ideation
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.
Measured: 9 months
PROMIS Short Form (SF) v2.0-Ability to Participate in Social Activities 8a
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.
Measured: 9 months
EORTC QLQ-Head Neck 35 Trouble with Social Eating Subscale
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.
Measured: 9 months
EORTC QLQ-HN35 Trouble with Social Contact Subscale
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.
Measured: 9 months
Body Image Coping Strategies Inventory (BICSI)
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.
Measured: 9 months
Automatic Thoughts Questionnaire
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start14 Feb 2023
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Evan Graboyes, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442957
- Sponsor's protocol ID
- PRO 00110248
- Other IDs
- R37CA269385
- Acronym
- BRIGHT
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 among head and neck cancer survivors. Contemp Clin Trials. 2025 Jun;153:107888. doi: 10.1016/j.cct.2025.107888. Epub 2025 Mar 24.
PubMed 40139457
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05442957
- Acronym / sponsor ID
- BRIGHT / PRO 00110248
- Conditions
- Head and Neck Cancer, Body Image Disturbance, Body Image, Survivorship, Psychosocial Impairment, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRIGHT | Experimental | Behavioral: BRIGHTBRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist. |
| Attention Control | Active comparator | Behavioral: Attention ControlThe attention control arm is a manualized video tele-supportive care intervention that addresses non-body image aspects of HNC survivorship. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIGHTBRIGHT 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. | Behavioural | BRIGHT |
| Attention ControlAC 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. | Behavioural | Attention Control |
Primary outcome
IMAGE-HN
Time frame: 9 months
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 40139457Graboyes 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taylor McLeod, MPH contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIGHT in people with Head and Neck Cancer and Body Image Disturbance, run by Medical University of South Carolina at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan M Graboyes, MD (843-792-0719, graboyes@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMAGE-HN (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.