Building a Renewed ImaGe After Head & Neck Cancer Treatment

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Building a Renewed ImaGe After Head & Neck Cancer Treatment

Conditions
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Head and Neck Squamous Cell Carcinoma, Body Image Disturbance

Intervention / Treatment
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* Behavioral: cognitive behavioral therapy, face to face
* Behavioral: cognitive behavioral therapy, telemedicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT (face to face)<br>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. | Behavioral: cognitive behavioral therapy, face to face<br>* self-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method<br>|
| Experimental: CBT (telemedicine)<br>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 | Behavioral: cognitive behavioral therapy, telemedicine<br>* self-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Image Disturbance | Change in body image disturbance will be measured using Body Image Scale (BIS) scores from before and 3 months after intervention. The BIS has been validated in oncology patients and is the most widely used scale for BID in oncology. It is a 10-item measure that is scored on a 4-point Likert scale; higher scores indicate greater body image dissatisfaction. It addresses the affective, cognitive, and emotional aspects of body image. There are no subscales. | Prior to intervention until 3 months after completion of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Image Investment | Body image investment (i.e. the importance and influence of appearance) will be measured using the Appearance Schemas Inventory-Revised (ASI-R). This 20-item measure is scored using a 5-point Likert scale with greater scores indicating greater body image investment. There are no subscales. | Prior to intervention until 3 months after completion of intervention. | 
| Change in Body Image Coping Strategies | Change in Body Image Coping strategies will be measured using the Body Image Coping Strategies Inventory (BICSI), a validated measure used to assess cognitive and behavioral responses to manage threats to body image. The subscales are Appearance Fixing (10 specific items on the scale), Avoidance (8 specific items on the scale), and Positive Rational Acceptance (11 items on the scale). Each subscale score is calculated as the mean of the items within that subscale. | Prior to intervention until 3 months after completion of intervention | 
| Change in Quality of Life | We will employ the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30/H&N35 module to evaluate quality of life (QOL). The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QOL) of cancer patients participating in international clinical trials. | Prior to intervention until 3 months after completion of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, body image disturbance, cognitive behavioral therapy, survivorship