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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Body Image Disturbance; Head and Neck Squamous Cell Carcinoma

Treatments: Behavioral: cognitive behavioral therapy, telemedicine; Behavioral: cognitive behavioral therapy, face to face

Study type: Interventional

Funder types: Other

Identifiers

NCT03518671

120834

Details and patient eligibility

About

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).

Full description

The investigators will complete a single-arm, phase II pilot study of time-limited CBT on BID in patients with surgically-treated HNC. Reliable, validated patient-reported outcome (PRO) measures of BID will be collected before, 1 month and 3 months after the CBT intervention to provide preliminary data on the effectiveness of CBT for BID in patients with surgically-treated HNC, addressing this critical knowledge gap. It is expected that time-limited CBT implemented in the post-treatment period will decrease BID and improve QOL in affected patients.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

CBT (face to face)

Experimental group

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.

Treatment:

Behavioral: cognitive behavioral therapy, face to face

CBT (telemedicine)

Experimental group

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

Treatment:

Behavioral: cognitive behavioral therapy, telemedicine