Body Image After Head and Neck Cancer Treatment

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: e-learning didactic module; Behavioral: Personal reflection activities

• Registration Number: NCT04830488
• Lead Sponsor: Bethany Rhoten

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

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-31
• Study Start: 2021-04-05
• Study First Posted: 2021-04-05
• Primary Completion: 2024-03-04
• Study Completion: 2024-03-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Body Image after Head and Neck Cancer Treatment	e-learning didactic module	-
Body Image after Head and Neck Cancer Treatment	Personal reflection activities	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants who complete program	Approximately 6 weeks
Percentage of participants who will rate program as acceptable	Approximately 6 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with improvement in body image indicators	Approximately 6 weeks

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States