Back to resultsBuilding a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT)
Primary Purpose
Head and Neck Squamous Cell Carcinoma, Body Image Disturbance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral therapy, face to face
cognitive behavioral therapy, telemedicine
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Squamous Cell Carcinoma focused on measuring head and neck cancer, body image disturbance, cognitive behavioral therapy, survivorship
Eligibility Criteria
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CBT (face to face)
CBT (telemedicine)
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03518671
First Posted
April 9, 2018
Last Updated
February 20, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT03518671
Brief Title
Building a Renewed ImaGe After Head & Neck Cancer Treatment
Acronym
BRIGHT
Official Title
Building a Renewed ImaGe After Head & Neck Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma, Body Image Disturbance
Keywords
head and neck cancer, body image disturbance, cognitive behavioral therapy, survivorship
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT (face to face)
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT (telemedicine)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy, face to face
Intervention Description
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy, telemedicine
Intervention Description
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform
Primary Outcome Measure Information:
Title
Change in Body Image Disturbance
Description
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.
Time Frame
Prior to intervention until 3 months after completion of intervention
Secondary Outcome Measure Information:
Title
Change in Body Image Investment
Description
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.
Time Frame
Prior to intervention until 3 months after completion of intervention.
Title
Change in Body Image Coping Strategies
Description
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.
Time Frame
Prior to intervention until 3 months after completion of intervention
Title
Change in Quality of Life
Description
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.
Time Frame
Prior to intervention until 3 months after completion of intervention
Other Pre-specified Outcome Measures:
Title
Change in Shame and Stigma
Description
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.
Time Frame
Prior to intervention until 3 months after completion of intervention
Title
Change in Depression and Anxiety
Description
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.
Time Frame
Prior to intervention until 3 months after completion of intervention
Title
Change in Social Roles and Isolation
Description
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.
Time Frame
Prior to intervention until 3 months after completion of intervention
Title
Change in Head and Neck Performance Status and Function
Description
This outcome will be measured by the Performance Status Scale for Head & Neck Cancer, which assesses performance in domains of eating, speech, and diet.
Time Frame
Prior to intervention until 3 months after completion of intervention
Title
Effectiveness of CBT and Telemedicine Utilization Patterns
Description
We will collect data from patients to understand why they chose face-face CBT versus telemedicine.
Time Frame
One month after completion of study intervention
Title
Qualitative Assessment of Experience with BID and CBT
Description
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.
Time Frame
One month after completion of study intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Building a Renewed ImaGe After Head & Neck Cancer Treatment
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