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NCT04830488 Clinical Trial

Body Image After Head and Neck Cancer Treatment

Head and Neck Cancer Clinical Trial

— BIHNC  

Official title:
Pilot Testing of the Body Image After Head and Neck Cancer Treatment (BIHNC) Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04830488
Other study ID # VICC HN 2123
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 5, 2021
Est. completion date July 2025

Study information
Verified date November 2023
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot study of the Body Image after Head and Neck Cancer Treatment Program [BIHNC]. It is a six-week, psychoeducational, web-based program that includes e-learning didactic modules and personal reflection activities for participants to complete.

Description:

Specific Aim 1: To assess the feasibility and acceptability of [BIHNC] in patients who have completed treatment for head and neck cancer and who have body image concerns. H1a: Eighty percent of enrolled study participants who complete baseline self-report measures will complete the BIHNC Program. H1b: Eighty percent of study participants completing the BIHNC Program will rate it acceptable on the intervention evaluation form. Specific Aim 2: To assess the preliminary efficacy of BIHNC for reducing body image concerns in patients who have completed treatment for head and neck cancer and who have body image concerns. H2: Body image scores will improve from pre- to post- intervention

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 7
Est. completion date July 2025
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Completion of any form of head and neck cancer treatment between 3 and 24 months previously at study enrollment - Answer in the affirmative to at least one of two questions concerning dissatisfaction with the way their body looks or function - Have clinically significant body image concerns as defined by (BIS score > 10) Exclusion Criteria: - Undergoing head and neck cancer treatment at time of study enrollment - Cognitive impairment that would preclude ability to provide informed consent - Unable to read text on a computer screen - Not able to read and understand English

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• e-learning didactic module
Participants utilize e-learning
• Personal reflection activities
Participants complete questionnaires

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Bethany Rhoten

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants who complete program Approximately 6 weeks
Primary Percentage of participants who will rate program as acceptable Approximately 6 weeks
Secondary Percentage of participants with improvement in body image indicators Approximately 6 weeks
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