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

• ClinicalTrials.gov Identifier: NCT03831100
• Recruitment Status: Recruiting
• First Posted: February 5, 2019
• Last Update Posted: July 21, 2021
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Evan Graboyes, Medical University of South Carolina

Study Description

Brief Summary:

HNC survivors with BID will be randomized to 5-weeks of tablet-based BRIGHT (n=24) or tablet-based AC (electronic information about HNC recovery; n=24). Participants will complete the Body Image Scale (a validated measure of BID; primary outcome) and measures of psychological, social, and emotional wellbeing (secondary outcomes) at baseline, 1-week, and 1-month and 3-month post-intervention to assess the preliminary clinical impact of BRIGHT on BID in HNC survivors.

HNC survivors in BRIGHT or AC will complete the Body Image Coping Strategies Inventory (mediator; a validated measure of body image coping behavior) at baseline, 1-week, 1-month, and 3-months post-intervention to assess the role of image coping behavior as the behavioral mechanism of BRIGHT.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Behavioral: BRIGHT; Behavioral: Active Control	Not Applicable

Detailed Description:

Following screening and informed consent, eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants will then be randomized to BRIGHT (n=24) or AC (n=24) 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. BRIGHT Therapist: A licensed clinical psychologist (Consultant: Stacey Maurer, PhD) with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT. Dr. Maurer developed the BRIGHT manual and worked with the study team to deliver BRIGHT in our single-arm pilot study.

The control intervention in this study 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-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 URL 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment

Intervention Model Description

Eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants will then be randomized to BRIGHT (n=24) or AC (n=24) 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. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT.

The control intervention in this study 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.

• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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)
• Actual Study Start Date: July 13, 2020
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in BIS score from baseline to 1-month post intervention [ Time Frame: 3 months ]
   The primary clinical endpoint is change in Body Image Scale (BIS) score from baseline to 1-month post intervention. The 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. The BIS is a reliable PROM validated in oncology patients and has been widely used to study BID in patients with HNC.

Secondary Outcome Measures :

1. Change in Body Image Coping Strategies Inventory (BICSI) scores from baseline to 1-month post intervention. [ Time Frame: 3 months ]
   The BICSI is a 29-item validated measure of the cognitive and behavioral responses to manage threats to body image. Items are scored on a 4-point Likert scale; scores range from 0-57 with higher scores indicating better coping strategies.
2. Change in IMAGE-HN scores [ Time Frame: 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. Raw scores for each sub-scale as well as the global scale can be converted to scaled scores for each, which range from 0-100 with higher scores representing greater HNC-related BID.
3. Change in Shame and Stigma Scale scores [ Time Frame: 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.
4. Change in PROMIS SF v1.0-Depression 8a scores [ Time Frame: 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). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe depressive symptoms.
5. Change in PROMIS SF v1.0-Anxiety 8a scores [ Time Frame: 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.
6. Change in PROMIS SF v2.0- Satisfaction with Social Roles and Activities 8a scores [ Time Frame: 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 more severe anxiety.
7. Change in PROMIS SC v2.0-Social Isolation 8a scores [ Time Frame: 3 months ]
   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.

Eligibility Criteria

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

Criteria

Inclusion Criteria

1. Age > 18 years at the time of screening
2. History of pathologically confirmed invasive SCC (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. 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)
5. Subjects who are enrolled into the study and undergo a 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 will be excluded.
6. Subjects who are enrolled in the study and develop a recurrence of their index HNC (local, regional or distant recurrence, radiologic or biopsy-proven) or metachronous second primary cancer (radiologic or biopsy-proven) during the study intervention or follow-up period will be excluded.

Contacts and Locations

Contacts

Contact: Evan M Graboyes, MD, MPH; (854) 792-0719; graboyes@musc.edu

Locations

United States, South Carolina

Medical University of South Carolina; Recruiting

Charleston, South Carolina, United States, 29425

Contact: Evan M Graboyes, MD, MPH 843-876-1176 graboyes@musc.edu

Principal Investigator: Evan M Graboyes, MD, MPH

Sponsors and Collaborators

Medical University of South Carolina

Investigators

• Principal Investigator: Evan M Graboyes, MD, MPH; Medical University of South Carolina

More Information

• Responsible Party: Evan Graboyes, Associate Professor, Department of Otolaryngology- Head and Neck Surgery, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03831100
• Other Study ID Numbers: Pro00085204
• First Posted: February 5, 2019
• Last Update Posted: July 21, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms