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

NCT03831100 | Completed Results

• 2 other identifiers: Pro000852041R21CA245941-01A1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in Body Image Scale Score From Baseline to 3-months Post-intervention

  3 months

• Change in IMAGE-HN Score From Baseline to 1-month Post-intervention

  1 month

• Change in IMAGE-HN Score From Baseline to 3-months Post-intervention

  3 months

• Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention

  1 month

• Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention

  3 months

Study Arms (2)

BRIGHT

EXPERIMENTAL

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

Active Control

PLACEBO COMPARATOR

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

Interventions

BRIGHT BEHAVIORAL

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.

BRIGHT

Active Control BEHAVIORAL

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.

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

• Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Mechanism underlying a brief cognitive behavioral treatment for head and neck cancer survivors with body image distress. Support Care Cancer. 2023 Dec 16;32(1):32. doi: 10.1007/s00520-023-08248-7.

  PMID: 38102496 DERIVED

• Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress. Res Sq [Preprint]. 2023 Sep 6:rs.3.rs-3303379. doi: 10.21203/rs.3.rs-3303379/v1.

  PMID: 37720013 DERIVED

• Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Efficacy of a brief cognitive behavioral therapy for head and neck cancer survivors with body image distress: secondary outcomes from the BRIGHT pilot randomized clinical trial. J Cancer Surviv. 2025 Feb;19(1):140-148. doi: 10.1007/s11764-023-01454-6. Epub 2023 Aug 29.

  PMID: 37644354 DERIVED

• Graboyes EM, Kistner-Griffin E, Hill EG, Maurer S, Balliet W, Williams AM, Padgett L, Yan F, Rush A, Johnson B, McLeod T, Dahne J, Ruggiero KJ, Sterba KR. Efficacy of a Brief Cognitive Behavioral Therapy for Head and Neck Cancer Survivors with Body Image Distress: Secondary Outcomes from the BRIGHT Pilot Randomized Clinical Trial. Res Sq [Preprint]. 2023 Aug 7:rs.3.rs-3222601. doi: 10.21203/rs.3.rs-3222601/v1.

  PMID: 37609318 DERIVED

• Graboyes EM, Maurer S, Balliet W, Li H, Williams AM, Osazuwa-Peters N, Yan F, Padgett L, Rush A, Ruggiero KJ, Sterba KR. Efficacy of a Brief Tele-Cognitive Behavioral Treatment vs Attention Control for Head and Neck Cancer Survivors With Body Image Distress: A Pilot Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jan 1;149(1):54-62. doi: 10.1001/jamaoto.2022.3700.

  PMID: 36454561 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Evan Graboyes
• Organization: Medical University of South Carolina

graboyes@musc.edu

843-792-0719

Study Officials

• Evan M Graboyes, MD, MPH

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Otolaryngology- Head and Neck Surgery

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 5, 2019
• Study Start: July 13, 2020
• Primary Completion: February 22, 2022
• Study Completion: April 20, 2022
• Last Updated: August 9, 2023
• Results First Posted: August 9, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)