Body Image Disturbance, Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
head and neck cancer, body image disturbance, cognitive behavioral therapy, survivorship
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.
Interventions
BEHAVIORALcognitive behavioral therapy, face to face
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method
BEHAVIORALcognitive behavioral therapy, telemedicine
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform
Sponsors
Medical University of South Carolina
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of CBT and Telemedicine Utilization Patterns | One month after completion of study intervention | We will collect data from patients to understand why they chose face-face CBT versus telemedicine. |
| Change in Shame and Stigma | Prior to intervention until 3 months after completion of intervention | 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. |
| Qualitative Assessment of Experience with BID and CBT | One month after completion of study intervention | 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 Depression and Anxiety | Prior to intervention until 3 months after completion of intervention | 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. |
| Change in Social Roles and Isolation | Prior to intervention until 3 months after completion of intervention | 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. |
| Change in Head and Neck Performance Status and Function | Prior to intervention until 3 months after completion of intervention | This outcome will be measured by the Performance Status Scale for Head & Neck Cancer, which assesses performance in domains of eating, speech, and diet. |
Countries
United States
Outcome results
None listed