What side effects are associated with this type of intervention?

Common treatments for head and neck cancers include surgery, radiation therapy, and chemotherapy. Known side effects of these treatments can significantly impact quality of life and include xerostomia (dry mouth), voice problems, and skin changes. Radiation therapy, in particular, can lead to long-term issues such as severe xerostomia and impaired social relations. Psychoeducational and personal reflection programs, like the Body Image after Head and Neck Cancer Treatment Program, aim to address the psychological and emotional challenges, including body image concerns, that arise from these physical side effects.

What prior FDA approvals exist?

The FDA has approved cetuximab, an EGFR-targeting monoclonal antibody, for use in combination with radiation therapy for locally advanced head and neck squamous cell carcinoma (HNSCC) and as a single agent for metastatic HNSCC. Additionally, pembrolizumab, an immunotherapy drug, has been approved for use in combination with cetuximab for treatment-refractory metastatic head and neck cancer. These treatments are relevant to the Body Image after Head and Neck Cancer Treatment Program, which focuses on psychoeducation and personal reflection for patients undergoing such treatments.

What other types of research exist?

Promising alternatives to the Body Image after Head and Neck Cancer Treatment Program for 2024 include: 1) Multidisciplinary rehabilitation programs that integrate physical therapy, speech therapy, and psychological support. 2) Virtual reality (VR) and augmented reality (AR) interventions for immersive therapy and body image rehabilitation. 3) Personalized medicine approaches that tailor rehabilitation and psychological support based on genetic and psychosocial profiles. 4) Integrative medicine practices combining conventional treatments with complementary therapies such as mindfulness, yoga, and acupuncture to address both physical and emotional well-being.

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Web-Based Program for Body Image After Head and Neck Cancer Treatment (BIHNC Trial)

N/A

Waitlist Available

Led By Bethany Rhoten, PhD

Research Sponsored by Bethany Rhoten

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 weeks

Awards & highlights

BIHNC Trial Summary

This trial will test a new web-based program to help people with head and neck cancer cope with their body image after treatment.

Who is the study for?

This trial is for individuals who finished head and neck cancer treatment between 3-24 months ago, are unhappy with their body's appearance or function post-treatment, and have significant body image concerns (BIS score > 10). It excludes those with cognitive impairments, inability to read computer text, non-English speakers, or anyone still in cancer treatment.Check my eligibility

What is being tested?

The study tests a six-week online program called BIHNC designed to help survivors of head and neck cancers. The program includes educational modules and personal reflection activities aimed at improving participants' body image.See study design

What are the potential side effects?

Since the interventions are psychoeducational rather than medical treatments, traditional side effects like you'd see with medication aren't expected. Participants may experience emotional discomfort while reflecting on their body image.

BIHNC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants who complete program

Percentage of participants who will rate program as acceptable

Secondary outcome measures

Percentage of participants with improvement in body image indicators

BIHNC Trial Design

1Treatment groups

Experimental Treatment

Group I: Body Image after Head and Neck Cancer TreatmentExperimental Treatment2 Interventions

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Cancers include surgery, radiotherapy, chemotherapy, and targeted therapy. Surgery involves the physical removal of the tumor, which is crucial for eliminating cancerous cells. Radiotherapy uses high-energy radiation to destroy cancer cells and shrink tumors, while chemotherapy employs drugs to kill rapidly dividing cancer cells throughout the body. Targeted therapy focuses on specific molecules involved in cancer growth, offering a more precise treatment approach. These treatments are essential for controlling and potentially curing the cancer. Additionally, psychoeducation and personal reflection, as studied in the Body Image after Head and Neck Cancer Treatment Program, play a significant role in helping patients cope with the psychological and emotional impacts of their treatment, improving their overall quality of life and aiding in their recovery.

Patients' and health professionals' experience of the Danish fast track treatment pathway for head and neck cancer patients receiving oral rehabilitation.Comprehensive treatment of squamous cell cancer of head and neck: Chinese expert consensus 2013.Integration of prospective quality of life and nutritional assessment as routine components of multidisciplinary care of patients with head and neck cancer.

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Who is running the clinical trial?

Bethany RhotenLead Sponsor

Bethany Rhoten, PhDPrincipal Investigator - Vanderbilt Medical Center

Vanderbilt-Ingram Cancer Center

1 Previous Clinical Trials

Media Library

Personal reflection activities Clinical Trial Eligibility Overview. Trial Name: NCT04830488 — N/A

Head and Neck Cancers Research Study Groups: Body Image after Head and Neck Cancer Treatment

Head and Neck Cancers Clinical Trial 2023: Personal reflection activities Highlights & Side Effects. Trial Name: NCT04830488 — N/A

Personal reflection activities 2023 Treatment Timeline for Medical Study. Trial Name: NCT04830488 — N/A

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