Building a Renewed ImaGe After Head & Neck Cancer Treatment
NCT ID: NCT03518671
Last Updated: 2023-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2018-02-08
2019-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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CBT (face to face)
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.
cognitive behavioral therapy, face to face
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method
CBT (telemedicine)
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
cognitive behavioral therapy, telemedicine
self-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Known distant metastatic disease
* Inability or unwillingness of subject or legal guardian/representative to give informed consent
18 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Evan Graboyes
Associate Professor, Department of Otolaryngology
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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120834
Identifier Type: -
Identifier Source: org_study_id
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