Clinical trial · Interventional
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0
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)
NCT03831100CI-TRIAL-00068700BRIGHTcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Control | Behavioral | — | UNRESOLVED |
| BRIGHT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BRIGHT
- description
- 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.
- interventionNames
- Behavioral: BRIGHT
- type
- PLACEBO_COMPARATOR
- label
- Active Control
- description
- 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.
- interventionNames
- Behavioral: Active Control
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (5)
- DERIVEDGraboyes 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
- DERIVEDGraboyes 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
- DERIVEDGraboyes 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
- DERIVEDGraboyes 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
- DERIVEDGraboyes 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