Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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.

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

self-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method

cognitive behavioral therapy, face to face

self-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform

cognitive behavioral therapy, telemedicine

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).

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.

Building a Renewed ImaGe After Head & Neck Cancer Treatment

Change in shame and stigma will be measured using the Shame and Stigma Scale, a 20-item, validated tool that measures shame with appearance, stigma, regret, and social/speech concerns in patients with HNC.

Change in Depression and Anxiety will be measured using Patient-Reported Outcomes Measure Information System (PROMIS), a validated questionnaire developed by the NIH for evaluating health-related quality of life.

Social roles and isolation will be assessed by Patient-Reported Outcomes Measure Information System (PROMIS) measures, a validated questionnaire developed by the NIH for evaluating health-related quality of life.

This outcome will be measured by the Performance Status Scale for Head \& Neck Cancer, which assesses performance in domains of eating, speech, and diet.

We will collect data from patients to understand why they chose face-face CBT versus telemedicine.

To better understand patient experiences with BID not captured in the questionnaires as well as their experiences with CBT, we will perform semi-structured interviews. Participants will be asked to 1) discuss their preferences about the timing, format and content of the CBT sessions 2) describe their program experiences and offer recommendations to improve delivery, and 3) and assess feasibility and acceptability of the intervention. This mixed methods approach will allow for an in-depth exploration of patient experiences, help refine the study intervention, and inform intervention implementation for future studies.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Building a Renewed ImaGe After Head & Neck Cancer Treatment	NCT03518671	Head and Neck S... Body Image Dist...	cognitive behav... cognitive behav...	18 Years -	Medical University of South Carolina
Building a Renewed ImaGe After Head & Neck Cancer Treatment	NCT03518671	Head and Neck S... Body Image Dist...	cognitive behav... cognitive behav...	18 Years -	Medical University of South Carolina

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