Body Image After Head and Neck Cancer Treatment (BIHNC)
Primary Purpose
Head and Neck Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-learning didactic module
Personal reflection activities
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring body image
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Body Image after Head and Neck Cancer Treatment
Arm Description
Outcomes
Primary Outcome Measures
Percentage of participants who complete program
Percentage of participants who will rate program as acceptable
Secondary Outcome Measures
Percentage of participants with improvement in body image indicators
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04830488
Brief Title
Body Image After Head and Neck Cancer Treatment
Acronym
BIHNC
Official Title
Pilot Testing of the Body Image After Head and Neck Cancer Treatment (BIHNC) Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bethany Rhoten
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
body image
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body Image after Head and Neck Cancer Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
e-learning didactic module
Intervention Description
Participants utilize e-learning
Intervention Type
Behavioral
Intervention Name(s)
Personal reflection activities
Intervention Description
Participants complete questionnaires
Primary Outcome Measure Information:
Title
Percentage of participants who complete program
Time Frame
Approximately 6 weeks
Title
Percentage of participants who will rate program as acceptable
Time Frame
Approximately 6 weeks
Secondary Outcome Measure Information:
Title
Percentage of participants with improvement in body image indicators
Time Frame
Approximately 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany Rhoten, PhD
Organizational Affiliation
Vanderbilt Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Body Image After Head and Neck Cancer Treatment
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