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

Must not have

Undergoing head and neck cancer treatment at time of study enrollment

Cognitive impairment that would preclude ability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online program to help people who have finished head and neck cancer treatment feel better about their body image. The program includes educational lessons and personal reflection activities. It aims to see if the program is feasible, acceptable, and effective in improving body image.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently receiving treatment for head and neck cancer.

Select...

I am able to understand and make decisions about my health care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

e-learning didactic module

2021

N/A

~10

Personal reflection activities

2021

N/A

~10

0 / 2Eligibility criteria met

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.