NCT04830488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 5, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

March 29, 2021

Last Update Submit

August 7, 2024

Conditions

Head and Neck Cancer

Keywords

body image

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants who complete program

    Approximately 6 weeks

  • Percentage of participants who will rate program as acceptable

    Approximately 6 weeks

Secondary Outcomes (1)

  • Percentage of participants with improvement in body image indicators

    Approximately 6 weeks

Study Arms (1)

Body Image after Head and Neck Cancer Treatment

EXPERIMENTAL
Behavioral: e-learning didactic moduleBehavioral: Personal reflection activities

Interventions

e-learning didactic moduleBEHAVIORAL

Participants utilize e-learning

Body Image after Head and Neck Cancer Treatment
Personal reflection activitiesBEHAVIORAL

Participants complete questionnaires

Body Image after Head and Neck Cancer Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Bethany Rhoten, PhD

    Vanderbilt Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 5, 2021

Study Start

April 5, 2021

Primary Completion

March 4, 2024

Study Completion

March 4, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)