Cognitive Behavior Therapy for the Reduction of Body Image Disturbance in Head and Neck Cancer Survivors, The BRIGHT 2.0 Trial

PRIMARY OBJECTIVE:

I. To assess the clinical efficacy of BRIGHT compared with active control (AC) on body image disturbance (BID) in head and neck cancer (HNC) survivors as determined by change in Body Image Scale (BIS) scores at 1-month post-intervention relative to baseline.

SECONDARY OBJECTIVES:

I. To assess the clinical efficacy of BRIGHT compared with AC on BID in HNC survivors as determined by change in Inventory to Measure and Assess imaGe disturbancE-Head & Neck (IMAGE-HN) scores at 1-month post-intervention relative to baseline and 3-months post-intervention relative to baseline.

II. To explore the behavioral mechanism of action of BRIGHT on changes in BID in HNC survivors as measured by the change in BICSI scores at 1-week post-intervention relative to baseline.

III. To provide preliminary estimates of the clinical effect of AC on BID in HNC survivors as determined by change in BIS scores at 1-month post-intervention relative to baseline.

IV. To estimate the activity of BRIGHT compared with AC on BID in HNC survivors in terms of clinical response as measured by improvement in BIS scores at 1-month post-intervention relative to baseline.

V. To assess the clinical efficacy of BRIGHT compared with AC on BID in HNC survivors as determined by change in BIS scores at 3-months post-intervention relative to baseline.

VI. To evaluate the preliminary clinical efficacy of BRIGHT compared with AC on changes in psychological, emotional, and social well-being in HNC survivors as determined by change in respective Patient Reported Outcomes Measurement (PROM) scores at 1- and 3-months post-intervention relative to baseline.

VII. To evaluate the feasibility of BRIGHT, delivered via a tablet-based telemedicine, as a strategy to treat BID in HNC survivors.

VIII. To evaluate the acceptability of BRIGHT to as a strategy to treat BID in HNC survivors.

IX. To determine the association of demographic variables with therapeutic alliance between the study participant and psychologist.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (BRIGHT): Patients attend 5 weekly tablet-based BRIGHT sessions over 60 minutes each.

ARM II (AC): Patients attend 5 weekly tablet-based AC sessions over 30 minutes each receiving standard of care educational information about head and neck cancer survivorship.

After completion of study, patients are followed up at 1 and 3 months.