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Completed

NCT Number: NCT04830488

Body Image After Head and Neck Cancer Treatment

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e-learning didactic module

Behavioral

Participants utilize e-learning

Personal reflection activities

Behavioral

Participants complete questionnaires

Primary outcomes

  1. Percentage of participants who complete program

    Time frame: Approximately 6 weeks

  2. Percentage of participants who will rate program as acceptable

    Time frame: Approximately 6 weeks

Secondary outcomes

  1. Percentage of participants with improvement in body image indicators

    Time frame: Approximately 6 weeks

Sponsors and collaborators

Lead sponsor

Bethany Rhoten

Other

Registry information

Official study title

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

Acronym: BIHNC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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