Clinical trial NCT03518671: Building a Renewed ImaGe After Head & Neck Cancer Treatment
Official title: Building a Renewed ImaGe After Head & Neck Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Body Image Disturbance
Keywords: head and neck cancer
body image disturbance
cognitive behavioral therapy
survivorship
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Body Image Disturbance
timeFrame: Prior to intervention until 3 months after completion of intervention
Secondary outcomes:
measure: Change in Body Image Investment
timeFrame: Prior to intervention until 3 months after completion of intervention.
measure: Change in Body Image Coping Strategies
timeFrame: Prior to intervention until 3 months after completion of intervention
measure: Change in Quality of Life
timeFrame: Prior to intervention until 3 months after completion of intervention
Other outcomes:
measure: Change in Shame and Stigma
timeFrame: Prior to intervention until 3 months after completion of intervention
measure: Change in Depression and Anxiety
timeFrame: Prior to intervention until 3 months after completion of intervention
measure: Change in Social Roles and Isolation
timeFrame: Prior to intervention until 3 months after completion of intervention
measure: Change in Head and Neck Performance Status and Function
timeFrame: Prior to intervention until 3 months after completion of intervention
measure: Effectiveness of CBT and Telemedicine Utilization Patterns
timeFrame: One month after completion of study intervention
measure: Qualitative Assessment of Experience with BID and CBT
timeFrame: One month after completion of study intervention
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: