Building a Renewed ImaGe After Head & Neck Cancer Treatment

Head and Neck Squamous Cell Carcinoma Clinical Trial

— BRIGHT  

Official title:

Building a Renewed ImaGe After Head & Neck Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518671
• Other study ID #: 120834
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: August 22, 2019

Study information

• Verified date: February 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 22, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Body Image Disturbance
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Behavioral:
• cognitive behavioral therapy, face to face
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method
• cognitive behavioral therapy, telemedicine
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Shame and Stigma	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.	Prior to intervention until 3 months after completion of intervention
Other	Change in Depression and Anxiety	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.	Prior to intervention until 3 months after completion of intervention
Other	Change in Social Roles and Isolation	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.	Prior to intervention until 3 months after completion of intervention
Other	Change in Head and Neck Performance Status and Function	This outcome will be measured by the Performance Status Scale for Head & Neck Cancer, which assesses performance in domains of eating, speech, and diet.	Prior to intervention until 3 months after completion of intervention
Other	Effectiveness of CBT and Telemedicine Utilization Patterns	We will collect data from patients to understand why they chose face-face CBT versus telemedicine.	One month after completion of study intervention
Other	Qualitative Assessment of Experience with BID and CBT	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.	One month after completion of study intervention
Primary	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	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.
Secondary	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
Secondary	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