Clinical trial · Interventional
Building a Renewed ImaGe After Head & Neck Cancer Treatment
NCT03518671CI-TRIAL-00064536BRIGHTcompletedN/AClinicalTrials.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)
This study will evaluate whether a time-limited cognitive behavioral therapy (CBT) intervention in the post-treatment time period can address body image disturbance (BID) in patients with surgically-treated head and neck cancer (HNC), thereby improving BID and quality of life (QOL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Image Disturbance | — | UNRESOLVED | — |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive behavioral therapy, face to face | Behavioral | — | UNRESOLVED |
| cognitive behavioral therapy, telemedicine | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CBT (face to face)
- description
- Self-limited cognitive behavioral therapy (CBT) delivered via 6 weekly sessions, face-face Up to one year after completion of treatment, patients with body image disturbance (BID) as determined by a Body Image Scale (BIS) score \> 5 will undergo time-limited CBT consisting of 6 weekly sessions. Each session will be guided by the HNC BID module that we develop but customized to each patient's specific concerns. Each session will last \~60 minutes and be conducted one-one with a psychologist. Patients will complete questionnaires prior to CBT and 1 and 3 months after CBT.
- interventionNames
- Behavioral: cognitive behavioral therapy, face to face
- type
- EXPERIMENTAL
- label
- CBT (telemedicine)
- description
- Self-limited cognitive behavioral therapy (CBT) delivered via 6 weekly sessions, via tablet-based telemedicine platform Up to one year after completion of treatment, patients with body image disturbance (BID) as determined by a Body Image Scale (BIS) score \> 5 will undergo time-limited CBT consisting of 6 weekly sessions. Each session will be guided by the HNC BID module that we develop but customized to each patient's specific concerns. Each session will last \~60 minutes and be conducted one-one with a psychologist. Patients will complete questionnaires prior to CBT and 1 and 3 months after CBT. To overcome the expected travel distance-related barrier to receipt of CBT, patients will receive the intervention via tablet-based telemedicine delivery platform
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic diagnosis of squamous cell carcinoma of the upper aerodigestive tract (oral cavity, oropharynx, hypopharynx, larynx) or cutaneous malignancy of the head and neck (e.g. squamous cell, basal cell, melanoma, etc) * Age \> 18 * American Joint Committee on Cancer (AJCC) stages I-IV * Curative intent therapy with surgery with or without adjuvant therapy * Body Image Scale (BIS) score \> 5 up to 1 year post-treatment Exclusion Criteria: * Inability to speak English * Known distant metastatic disease * Inability or unwillingness of subject or legal guardian/representative to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.