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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: BRIGHT; Behavioral: Active Control

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Age > 18 years at the time of screening
2. 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
3. History of curative intent surgery with or without adjuvant therapy, with or without reconstruction
4. American Joint Committee on Cancer (AJCC) 8th Edition pathologic stage grouping I-IV
5. Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)
6. 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
7. Willingness to be randomized to either BRIGHT or AC
8. Body Image Scale (BIS) score >/= 10

Exclusion Criteria:

1. Inability to speak or write English
2. 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.
3. Initiation or adjustment (< 3 months of baseline) of psychotropic medication.
4. Severe psychiatric comorbidity (e.g. suicidal ideation, psychosis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRIGHT; 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.	Behavioral: BRIGHT; 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.
Placebo Comparator: Active Control; 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.	Behavioral: Active Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Evan M Graboyes, MD, MPH, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Pro00085204; 1R21CA245941-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No