NCT03831100: BRIGHT

Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0

Completed NA Results posted Last updated 9 August 2023

What this trial tests

NA trial testing BRIGHT in Head and Neck Cancer in 54 participants. Completed in 20 April 2022.

Timeline

13 July 2020

Primary endpoint
22 February 2022

20 April 2022

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	54
Start date	13 July 2020
Primary completion	22 February 2022
Estimated completion	20 April 2022
Sites	1 location across United States

Drugs / interventions tested

• BRIGHT
• Active Control — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Medical University of South Carolina

Who can join

18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Body Image Scale Score From Baseline to 1-month Post-intervention Primary · 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.

Group	Value	95% CI
BRIGHT	-3.5	-5.4 – -1.5
Active Control	-0.7	-2.8 – 1.5

Change in Body Image Scale Score From Baseline to 3-months Post-intervention Secondary · 3 months

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.

Group	Value	95% CI
BRIGHT	-7.3	-9.7 – -4.8
Active Control	-1.6	-3.9 – 0.7

Change in IMAGE-HN Score From Baseline to 1-month Post-intervention Secondary · 1 month

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.

Group	Value	95% CI
BRIGHT	-8.1	-13.4 – -2.8
Active Control	0.5	-5.3 – 6.4

Change in IMAGE-HN Score From Baseline to 3-months Post-intervention Secondary · 3 months

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.

Group	Value	95% CI
BRIGHT	-17.8	-24.5 – -11.1
Active Control	-1.6	-7.8 – 4.6

Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention Secondary · 1 month

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.

Group	Value	95% CI
BRIGHT	-4.8	-8.9 – 0.6
Active Control	-1.8	-5.6 – 1.9

Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention Secondary · 3 months

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.

Group	Value	95% CI
BRIGHT	-10.6	-15.3 – -5.8
Active Control	-1.8	-6.1 – 2.6

Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention Secondary · 1 month

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.

Group	Value	95% CI
BRIGHT	-2.7	-5.1 – 0.2
Active Control	0.5	-1.7 – 2.8

Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention Secondary · 3 months

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.

Group	Value	95% CI
BRIGHT	-3.1	-6.1 – -0.1
Active Control	0.9	-1.8 – 3.6

Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention Secondary · 1 month

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.

Group	Value	95% CI
BRIGHT	-1.6	-4.3 – 1.1
Active Control	-0.3	-2.8 – 2.2

Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention Secondary · 3 months

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.

Group	Value	95% CI
BRIGHT	-3.1	-5.6 – -0.5
Active Control	-0.2	-2.5 – 2.1

Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention Secondary · 1 month

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.

Group	Value	95% CI
BRIGHT	3.0	0.6 – 5.5
Active Control	-1.0	-3.3 – 1.3

Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention Secondary · 3 months

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.

Group	Value	95% CI
BRIGHT	6.2	3.4 – 9.0
Active Control	2.2	-0.4 – 4.8

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Graboyes EM, Maurer S, Balliet W, Li H, et al · · 2023 · cited 13× · PMID 36454561 · DOI 10.1001/jamaoto.2022.3700
2. 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.
   Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, et al · · 2025 · cited 7× · PMID 37644354 · DOI 10.1007/s11764-023-01454-6
3. Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress.
   Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, et al · · 2023 · cited 6× · PMID 38102496 · DOI 10.1007/s00520-023-08248-7
4. Efficacy of a Brief Cognitive Behavioral Treatment Across Body Image Distress Domains: Secondary Outcomes of the BRIGHT Randomized Clinical Trial.
   Hullfish H, Kistner-Griffin E, Maurer S, Balliet W, et al · · 2025 · PMID 40367345 · DOI 10.1001/jamaoto.2025.0965
5. Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress
   Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, et al · · 2023 · DOI 10.21203/rs.3.rs-3303379/v1
6. 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
   Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, et al · · 2023 · DOI 10.21203/rs.3.rs-3222601/v1