Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0 (NCT03831100) | Clinical Trial Compass
CompletedNot Applicable
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0
United States54 participantsStarted 2020-07-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Change in Body Image Scale Score From Baseline to 1-month Post-intervention