Body Image After Head and Neck Cancer Treatment

NCT ID: NCT04830488

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-05

Study Completion Date

2024-03-04

Brief Summary

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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

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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

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Body Image after Head and Neck Cancer Treatment

Group Type EXPERIMENTAL

e-learning didactic module

Intervention Type BEHAVIORAL

Participants utilize e-learning

Personal reflection activities

Intervention Type BEHAVIORAL

Participants complete questionnaires

Interventions

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e-learning didactic module

Participants utilize e-learning

Intervention Type BEHAVIORAL

Personal reflection activities

Participants complete questionnaires

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bethany Rhoten

OTHER

Sponsor Role lead

Responsible Party

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Bethany Rhoten

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bethany Rhoten, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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VICC HN 2123

Identifier Type: -

Identifier Source: org_study_id

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