Building a Renewed ImaGe After Head & Neck Cancer Treatment

Not Applicable

Completed

Interventions: Behavioral: cognitive behavioral therapy, face to face
Behavioral: cognitive behavioral therapy, telemedicine

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
CBT (face to face)	cognitive behavioral therapy, face to face	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.
CBT (telemedicine)	cognitive behavioral therapy, telemedicine	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

Primary Outcome Measures

Name	Time	Method
Change in Body Image Disturbance	Prior to intervention until 3 months after completion of intervention	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	Prior to intervention until 3 months after completion of intervention	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.
Change in Body Image Coping Strategies	Prior to intervention until 3 months after completion of intervention	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.
Change in Body Image Investment	Prior to intervention until 3 months after completion of intervention.	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.

Locations (1): Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States