Head and Neck CancerBRIGHTNCT03831100
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0
A study testing BRIGHT in people with Head and Neck Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Head and neck cancer (HNC) survivors with body image-related distress (BID) will be randomized to 5-weeks of tablet-based BRIGHT or tablet-based active control (AC; electronic information about HNC recovery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- BRIGHT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 20 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 at the time of screening
- History of pathologically confirmed invasive squamous cell carcinoma (or histologic variant) of the upper aerodigestive tract (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
- American Joint Committee on Cancer (AJCC) 8th Edition pathologic stage grouping I-IV
- Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)
- 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
- Body Image Scale (BIS) score >/= 10
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Single-Site, Parallel-Group, Randomized-Controlled Pilot Trial Comparing BRIGHT With Active Control in Reducing Body Image Disturbance Among Head and Neck Cancer Survivors (BRIGHT 2.0)
Head and neck cancer (HNC) survivors with body image-related distress (BID) will be randomized to 5-weeks of tablet-based BRIGHT or tablet-based active control (AC; electronic information about HNC recovery). Participants will complete validated measures of BID and psychological, social, and emotional wellbeing to assess the preliminary clinical impact of BRIGHT on BID in HNC survivors. Participants will also complete validated measures of body image coping behavior to assess the role of image coping behavior as the behavioral mechanism of BRIGHT.
Read the detailed description
Following screening and informed consent, eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants (n=44) will then be randomized 1:1 to BRIGHT or AC and undergo weekly, tablet-based BRIGHT or AC for 5 weeks.
The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. The control intervention will be matched to replicate the frequency, intensity, and delivery method of BRIGHT. Participants in the AC arm will thus undergo 5 weekly, 60-minute, tablet-based video sessions in which they undergo non-manualized discussions with a non-trained member of the study team.
Following randomization, patients in each arm will receive a study-issued, cellular-enabled iPad loaded with Vidyo, a video teleconference platform that allows the participant to connect to the study psychologist (BRIGHT) or AC. Vidyo allows face-face communication for tele-cognitive behavioral therapy (CBT) for HNC patients who can articulate well, but also includes a within-video text message feature for aphonic (due to surgical removal of the larynx) or severely dysarthric (due to surgical removal of a significant amount of the tongue) HNC patients who are unable to participate in tele-CBT by speaking. The study iPads are locked to prevent downloading of additional applications. Participants receive a pictorial instructional booklet for logging on to Vidyo. No user names, logins, or web addresses are necessary to connect to the BRIGHT session. The participant simply clicks on the Vidyo application which takes the participant to the assigned teleconference room. At the conclusion of the 5-week intervention, participants return iPads to the study team in pre-addressed, stamped, padded mailers that are provided to the patient.
- Conditions
- Head and Neck Cancer
- Being tested
- BRIGHT, Active 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
The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT.
Active ControlBehavioural
AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session (Table 5) is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship.
| Study group | Role | What they receive |
|---|---|---|
| BRIGHT | Experimental | The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT. Receives: Behavioral: BRIGHT |
| Active Control | Placebo comparator | The control intervention in this study will be matched to replicate the frequency, intensity, and delivery method of BRIGHT. AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Image Scale Score From Baseline to 1-month Post-intervention
The Body Image Scale (BIS) is a validated, 10-item patient-reported outcome measure (PROM) that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.
Measured: 1 month
Secondary outcomes (13)
Change in Body Image Scale Score From Baseline to 3-months Post-intervention
The BIS is a validated, 10-item patient-reported outcome measure that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.
Measured: 3 months
Change in IMAGE-HN Score From Baseline to 1-month Post-intervention
The IMAGE-HN is a psychometrically sound, 24-item, multi-domain PROM consisting of 4 sub-scales and a global scale that can be used to measure key aspects of HNC-related body image distress (BID) due to HNC or its treatment. Responses include 'Never', 'Rarely', 'Sometimes', 'Often', 'Always', corresponding to a Likert scale of 0-4, respectively. Total IMAGE-HN scores on the global domain (21 questions) range from 0-84, with higher scores indicated greater HNC-related body image dissatisfaction.
Measured: 1 month
Change in IMAGE-HN Score From Baseline to 3-months Post-intervention
The IMAGE-HN is a psychometrically sound, 24-item, multi-domain PROM consisting of 4 sub-scales and a global scale that can be used to measure key aspects of HNC-related BID due to HNC or its treatment. Responses include 'Never', 'Rarely', 'Sometimes', 'Often', 'Always', corresponding to a Likert scale of 0-4, respectively. Total IMAGE-HN scores on the global domain (21 questions) range from 0-84, with higher scores indicated greater HNC-related body image dissatisfaction.
Measured: 3 months
Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention
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. Responses include 'never', 'seldom', 'sometimes', 'often', and 'all the time' and are scored 0-4, respectively. The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored) and thus ranges from 0-80. Higher scores reflect greater shame and stigma from HNC.
Measured: 1 month
Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention
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. Responses include 'never', 'seldom', 'sometimes', 'often', and 'all the time' and are scored 0-4, respectively. The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored) and thus ranges from 0-80. Higher scores reflect greater shame and stigma from HNC.
Measured: 3 months
Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention
PROMIS SF v1.0-Depression 8a is a validated, 8-item measure developed by the NIH to assess self-reported negative mood, views of self, and decreased positive affect and engagement. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). Higher scores reflect more severe depressive symptoms.
Measured: 1 month
Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention
PROMIS SF v1.0-Depression 8a is a validated, 8-item measure developed by the NIH to assess self-reported negative mood, views of self, and decreased positive affect and engagement. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). Higher scores reflect more severe depressive symptoms.
Measured: 3 months
Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention
The PROMIS SF v1.0-Anxiety 8a is a validated, 8-item measure developed by the NIH to assess self-reported fear, worry, and hyperarousal46. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe anxiety.
Measured: 1 month
Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention
The PROMIS SF v1.0-Anxiety 8a is a validated, 8-item measure developed by the NIH to assess self-reported fear, worry, and hyperarousal46. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe anxiety.
Measured: 3 months
Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention
PROMIS SF v2.0-Satisfaction with Social Roles and Activities 8a is a validated, 8-item, measure developed by the NIH to assess self-reported satisfaction with performing one's usual social roles and activities. Items are scored using a 5-point Likert scale from 'not at all' to 'very much' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect greater satisfaction with social roles and activities.
Measured: 1 month
Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention
PROMIS SF v2.0-Satisfaction with Social Roles and Activities 8a is a validated, 8-item, measure developed by the NIH to assess self-reported satisfaction with performing one's usual social roles and activities. Items are scored using a 5-point Likert scale from 'not at all' to 'very much' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect greater satisfaction with social roles and activities.
Measured: 3 months
Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 1-month Post-intervention
PROMIS SF v2.0-Social Isolation 8a is a validated, 8-item, measure developed by the NIH to assess self-reported perceptions of being avoided, excluded or unknown by others. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe social isolation.
Measured: 1 month
Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 3-months Post-intervention
PROMIS SF v2.0-Social Isolation 8a is a validated, 8-item, measure developed by the NIH to assess self-reported perceptions of being avoided, excluded or unknown by others. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe social isolation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start13 Jul 2020
- Primary completion22 Feb 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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
- Single group
- Model description
- Eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants will then be randomized to BRIGHT (n=24) or AC (n=24) and undergo weekly, tablet-based BRIGHT or AC for 5 weeks. The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT. The control intervention in this study will be matched to replicate the frequency, intensity, and delivery method of BRIGHT. Participants in the AC arm will thus undergo 5 weekly, 60-minute, tablet-based video sessions in which they undergo non-manualized discussions with a non-trained member of the study team.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
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
- Investigators
- Evan M Graboyes, MD, MPH, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831100
- Sponsor's protocol ID
- Pro00085204
- Other IDs
- 1R21CA245941-01A1
- Acronym
- BRIGHT
- Status last verified
- Jul 2023
- First submitted
- 4 Feb 2019
- Last updated
- 9 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress. Support Care Cancer. 2023 Dec 16;32(1):32. doi: 10.1007/s00520-023-08248-7.
PubMed 38102496Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress. Res Sq [Preprint]. 2023 Sep 6:rs.3.rs-3303379. doi: 10.21203/rs.3.rs-3303379/v1.
PubMed 37720013Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Efficacy of a brief cognitive behavioral therapy for head and neck cancer survivors with body image distress: secondary outcomes from the BRIGHT pilot randomized clinical trial. J Cancer Surviv. 2025 Feb;19(1):140-148. doi: 10.1007/s11764-023-01454-6. Epub 2023 Aug 29.
PubMed 37644354Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Efficacy of a Brief Cognitive Behavioral Therapy for Head and Neck Cancer Survivors with Body Image Distress: Secondary Outcomes from the BRIGHT Pilot Randomized Clinical Trial. Res Sq [Preprint]. 2023 Aug 7:rs.3.rs-3222601. doi: 10.21203/rs.3.rs-3222601/v1.
PubMed 37609318Graboyes EM, Maurer S, Balliet W, Li H, Williams AM, Osazuwa-Peters N, Yan F, Padgett L, Rush A, Ruggiero KJ, Sterba KR. Efficacy of a Brief Tele-Cognitive Behavioral Treatment vs Attention Control for Head and Neck Cancer Survivors With Body Image Distress: A Pilot Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jan 1;149(1):54-62. doi: 10.1001/jamaoto.2022.3700.
PubMed 36454561
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Site, Parallel-Group, Randomized-Controlled Pilot Trial Comparing BRIGHT With Active Control in Reducing Body Image Disturbance Among Head and Neck Cancer Survivors (BRIGHT 2.0)
- ClinicalTrials.gov ID
- NCT03831100
- Acronym / sponsor ID
- BRIGHT / Pro00085204
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Posted 9 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Head and neck cancer (HNC) survivors with body image-related distress (BID) will be randomized to 5-weeks of tablet-based BRIGHT or tablet-based active control (AC; electronic information about HNC recovery). Participants will complete validated measures of BID and psychological, social, and emotional wellbeing to assess the preliminary clinical impact of BRIGHT on BID in HNC survivors. Participants will also complete validated measures of body image coping behavior to assess the role of image coping behavior as the behavioral mechanism of BRIGHT.
Detailed description
Following screening and informed consent, eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants (n=44) will then be randomized 1:1 to BRIGHT or AC and undergo weekly, tablet-based BRIGHT or AC for 5 weeks.
The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. The control intervention will be matched to replicate the frequency, intensity, and delivery method of BRIGHT. Participants in the AC arm will thus undergo 5 weekly, 60-minute, tablet-based video sessions in which they undergo non-manualized discussions with a non-trained member of the study team.
Following randomization, patients in each arm will receive a study-issued, cellular-enabled iPad loaded with Vidyo, a video teleconference platform that allows the participant to connect to the study psychologist (BRIGHT) or AC. Vidyo allows face-face communication for tele-cognitive behavioral therapy (CBT) for HNC patients who can articulate well, but also includes a within-video text message feature for aphonic (due to surgical removal of the larynx) or severely dysarthric (due to surgical removal of a significant amount of the tongue) HNC patients who are unable to participate in tele-CBT by speaking. The study iPads are locked to prevent downloading of additional applications. Participants receive a pictorial instructional booklet for logging on to Vidyo. No user names, logins, or web addresses are necessary to connect to the BRIGHT session. The participant simply clicks on the Vidyo application which takes the participant to the assigned teleconference room. At the conclusion of the 5-week intervention, participants return iPads to the study team in pre-addressed, stamped, padded mailers that are provided to the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants will then be randomized to BRIGHT (n=24) or AC (n=24) and undergo weekly, tablet-based BRIGHT or AC for 5 weeks. The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT. The control intervention in this study will be matched to replicate the frequency, intensity, and delivery method of BRIGHT. Participants in the AC arm will thus undergo 5 weekly, 60-minute, tablet-based video sessions in which they undergo non-manualized discussions with a non-trained member of the study team.
| Arm | Type | Receives |
|---|---|---|
| BRIGHT | Experimental | Behavioral: BRIGHTThe BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT. |
| Active Control | Placebo comparator | Behavioral: Active ControlThe control intervention in this study will be matched to replicate the frequency, intensity, and delivery method of BRIGHT. AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing 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 (8 listed)
- Age > 18 years at the time of screening
- History of pathologically confirmed invasive squamous cell carcinoma (or histologic variant) of the upper aerodigestive tract (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
- American Joint Committee on Cancer (AJCC) 8th Edition pathologic stage grouping I-IV
- Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| BRIGHTThe BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT. | Behavioural | BRIGHT |
| Active ControlAC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session (Table 5) is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship. | Behavioural | Active Control |
Primary outcome
Change in Body Image Scale Score From Baseline to 1-month Post-intervention
Time frame: 1 month
The Body Image Scale (BIS) is a validated, 10-item patient-reported outcome measure (PROM) that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.
13 secondary outcomes
Change in Body Image Scale Score From Baseline to 3-months Post-intervention
Time frame: 3 months
Change in IMAGE-HN Score From Baseline to 1-month Post-intervention
Time frame: 1 month
Change in IMAGE-HN Score From Baseline to 3-months Post-intervention
Time frame: 3 months
Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention
Time frame: 1 month
Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention
Time frame: 3 months
Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention
Time frame: 1 month
Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention
Time frame: 3 months
Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention
Time frame: 1 month
Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention
Time frame: 3 months
Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention
Time frame: 1 month
Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention
Time frame: 3 months
Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 1-month Post-intervention
Time frame: 1 month
Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 3-months Post-intervention
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38102496Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress. Support Care Cancer. 2023 Dec 16;32(1):32. doi: 10.1007/s00520-023-08248-7.
- Derived from this study: PubMed 37720013Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress. Res Sq [Preprint]. 2023 Sep 6:rs.3.rs-3303379. doi: 10.21203/rs.3.rs-3303379/v1.
- Derived from this study: PubMed 37644354Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Efficacy of a brief cognitive behavioral therapy for head and neck cancer survivors with body image distress: secondary outcomes from the BRIGHT pilot randomized clinical trial. J Cancer Surviv. 2025 Feb;19(1):140-148. doi: 10.1007/s11764-023-01454-6. Epub 2023 Aug 29.
- Derived from this study: PubMed 37609318Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Efficacy of a Brief Cognitive Behavioral Therapy for Head and Neck Cancer Survivors with Body Image Distress: Secondary Outcomes from the BRIGHT Pilot Randomized Clinical Trial. Res Sq [Preprint]. 2023 Aug 7:rs.3.rs-3222601. doi: 10.21203/rs.3.rs-3222601/v1.
- Derived from this study: PubMed 36454561Graboyes EM, Maurer S, Balliet W, Li H, Williams AM, Osazuwa-Peters N, Yan F, Padgett L, Rush A, Ruggiero KJ, Sterba KR. Efficacy of a Brief Tele-Cognitive Behavioral Treatment vs Attention Control for Head and Neck Cancer Survivors With Body Image Distress: A Pilot Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jan 1;149(1):54-62. doi: 10.1001/jamaoto.2022.3700.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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. This study is not recruiting at the moment.
Evan M Graboyes, MD, MPH principal investigator
Medical University of South Carolina
1 site 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, run by Medical University of South Carolina at 1 site 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Image Scale Score From Baseline to 1-month Post-intervention (time frame: 1 month). 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 NCT03831100, which also lists 5 linked publications.
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 9 Aug 2023.