Head and Neck Squamous Cell CarcinomaBRIGHTNCT03518671
Building a Renewed ImaGe After Head & Neck Cancer Treatment
A study testing cognitive behavioral therapy, face to face and cognitive behavioral therapy, telemedicine in people with Head and Neck Squamous Cell Carcinoma and Body Image Disturbance, run by Medical University of South Carolina at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Body Image Disturbance
- What is being tested?
- cognitive behavioral therapy, face to face and cognitive behavioral therapy, telemedicine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 22 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to speak English
- Known distant metastatic disease
- Inability or unwillingness of subject or legal guardian/representative to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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).
Read the 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.
- Being tested
- cognitive behavioral therapy, face to face, cognitive behavioral therapy, telemedicine
- Keywords
- head and neck cancer, body image disturbance, cognitive behavioral therapy, survivorship
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapy, face to faceBehavioural
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method
cognitive behavioral therapy, telemedicineBehavioural
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform
| Study group | Role | What they receive |
|---|---|---|
| CBT (face to face) | Experimental | 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. Receives: Behavioral: cognitive behavioral therapy, face to face |
| CBT (telemedicine) | Experimental | 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 Receives: Behavioral: cognitive behavioral therapy, telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to intervention until 3 months after completion of intervention
Secondary outcomes (3)
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.
Measured: Prior to intervention until 3 months after completion of intervention.
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.
Measured: Prior to intervention until 3 months after completion of intervention
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.
Measured: Prior to intervention until 3 months after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start8 Feb 2018
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Graboyes, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518671
- Sponsor's protocol ID
- 120834
- Acronym
- BRIGHT
- Status last verified
- Feb 2023
- First submitted
- 9 Apr 2018
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building a Renewed ImaGe After Head & Neck Cancer Treatment
- ClinicalTrials.gov ID
- NCT03518671
- Acronym / sponsor ID
- BRIGHT / 120834
- Keywords
- head and neck cancer, body image disturbance, cognitive behavioral therapy, survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT (face to face) | Experimental | Behavioral: cognitive behavioral therapy, face to faceSelf-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. |
| CBT (telemedicine) | Experimental | Behavioral: cognitive behavioral therapy, telemedicineSelf-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to speak English
- Known distant metastatic disease
- Inability or unwillingness of subject or legal guardian/representative to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapy, face to faceself-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method | Behavioural | CBT (face to face) |
| cognitive behavioral therapy, telemedicineself-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform | Behavioural | CBT (telemedicine) |
Primary outcome
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.
3 secondary outcomes
Change in Body Image Investment
Time frame: Prior to intervention until 3 months after completion of intervention.
Change in Body Image Coping Strategies
Time frame: Prior to intervention until 3 months after completion of intervention
Change in Quality of Life
Time frame: Prior to intervention until 3 months after completion of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy, face to face and cognitive behavioral therapy, telemedicine in people with Head and Neck Squamous Cell Carcinoma and Body Image Disturbance, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Image Disturbance (time frame: Prior to intervention until 3 months after completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.