Skip to main content
OpenTrials
Completed

NCT Number: NCT03518671

Building a Renewed ImaGe After Head & Neck Cancer Treatment

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Squamous Cell Carcinoma Body Image Disturbance Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral therapy, face to face

Behavioral

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

cognitive behavioral therapy, telemedicine

Behavioral

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

Primary outcomes

  1. Change in Body Image Disturbance

    Time frame: 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 outcomes

  1. Change in Body Image Investment

    Time frame: 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.

  2. Change in Body Image Coping Strategies

    Time frame: 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.

  3. Change in Quality of Life

    Time frame: 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 outcomes

  1. Change in Shame and Stigma

    Time frame: 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.

  2. Change in Depression and Anxiety

    Time frame: 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.

  3. Change in Social Roles and Isolation

    Time frame: 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.

  4. Change in Head and Neck Performance Status and Function

    Time frame: 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.

  5. Effectiveness of CBT and Telemedicine Utilization Patterns

    Time frame: One month after completion of study intervention

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

  6. Qualitative Assessment of Experience with BID and CBT

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: BRIGHT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 8, 2018
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.