Building a Renewed ImaGe After Head & Neck Cancer Treatment

NCT03518671 | Completed DMC

• 1 other identifier: 120834
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Squamous Cell Carcinoma; Body Image Disturbance

Keywords

head and neck cancer; body image disturbance; cognitive behavioral therapy; survivorship

Outcome Measures

Primary Outcomes (1)

• 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.

  Prior to intervention until 3 months after completion of intervention

Secondary Outcomes (3)

• Change in Body Image Investment

  Prior to intervention until 3 months after completion of intervention.

• Change in Body Image Coping Strategies

  Prior to intervention until 3 months after completion of intervention

• Change in Quality of Life

  Prior to intervention until 3 months after completion of intervention

Other Outcomes (6)

• Change in Shame and Stigma

  Prior to intervention until 3 months after completion of intervention

• Change in Depression and Anxiety

  Prior to intervention until 3 months after completion of intervention

• Change in Social Roles and Isolation

  Prior to intervention until 3 months after completion of intervention

Study Arms (2)

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.

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

Behavioral: cognitive behavioral therapy, telemedicine

Interventions

cognitive behavioral therapy, face to face BEHAVIORAL

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

CBT (face to face)

cognitive behavioral therapy, telemedicine BEHAVIORAL

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

CBT (telemedicine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to speak English
• Known distant metastatic disease
• Inability or unwillingness of subject or legal guardian/representative to give informed consent

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Cognitive Behavioral Therapy; Telemedicine

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Otolaryngology

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 8, 2018
• Study Start: February 8, 2018
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: March 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)