BIHNC: Body Image After Head and Neck Cancer Treatment

Sponsor

Bethany Rhoten (Other)

Overall Status

Recruiting

CT.gov ID

NCT04830488

Collaborator

(none)

Enrollment

Location

Arm

50.9

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Behavioral: e-learning didactic module Behavioral: Personal reflection activities	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 5, 2021

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage of participants who complete program [Approximately 6 weeks]
Percentage of participants who will rate program as acceptable [Approximately 6 weeks]

Secondary Outcome Measures

Percentage of participants with improvement in body image indicators [Approximately 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Bethany Rhoten

Investigators

Principal Investigator: Bethany Rhoten, PhD, Vanderbilt Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bethany Rhoten, Principal Investigator, Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier:

NCT04830488

Other Study ID Numbers:

VICC HN 2123

First Posted:

Apr 5, 2021

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bethany Rhoten, Principal Investigator, Vanderbilt-Ingram Cancer Center

body image

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Jul 7, 2022