Body Image After Head and Neck Cancer Treatment (BIHNC)

August 7, 2024 updated by: Bethany Rhoten

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Body Image after Head and Neck Cancer Treatment
Behavioral: e-learning didactic module
Participants utilize e-learning
Behavioral: Personal reflection activities
Participants complete questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who complete program
Time Frame: Approximately 6 weeks
Approximately 6 weeks
Percentage of participants who will rate program as acceptable
Time Frame: Approximately 6 weeks
Approximately 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with improvement in body image indicators
Time Frame: Approximately 6 weeks
Approximately 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bethany Rhoten

Investigators

  • Principal Investigator: Bethany Rhoten, PhD, Vanderbilt Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2021

Primary Completion (Actual)

March 4, 2024

Study Completion (Actual)

March 4, 2024

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC HN 2123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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