N/A N=54 Randomized Supportive Care

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

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03831100 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Change in Body Image Scale Score From Baseline to 1-month Post-intervention — -3.5; -0.7 score on a scale — p=0.25

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BRIGHT (Behavioral); Active Control (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Body Image Scale Score From Baseline to 1-month Post-intervention	-3.5; -0.7	0.25
SECONDARY Change in Body Image Scale Score From Baseline to 3-months Post-intervention	-7.3; -1.6	.006 sig
SECONDARY Change in IMAGE-HN Score From Baseline to 1-month Post-intervention	-8.1; 0.5	.10
SECONDARY Change in IMAGE-HN Score From Baseline to 3-months Post-intervention	-17.8; -1.6	.002 sig
SECONDARY Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention	-4.8; -1.8	0.30
SECONDARY Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention	-10.6; -1.8	0.005 sig
SECONDARY Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention	-2.7; 0.5	0.064
SECONDARY Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention	-3.1; 0.9	0.046 sig
SECONDARY Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention	-1.6; -0.3	0.49
SECONDARY Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention	-3.1; -0.2	0.14
SECONDARY Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention	3.0; -1.0	0.082
SECONDARY Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention	6.2; 2.2	0.15
SECONDARY Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 1-month Post-intervention	-2.9; -1.3	0.22
SECONDARY Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 3-months Post-intervention	-3.3; -1.0	0.093

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). 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.

Eligibility Criteria

Inclusion Criteria

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

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03831100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.