Symptom Assessment for Head Neoplasms

Phase-Based Estimates
1
Effectiveness
1
Safety
Eye and Ear Institute, Pittsburgh, PA
Head Neoplasms+1 More
Symptom Assessment - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Head Neoplasms

Study Summary

This study is evaluating whether a multidimensional symptom management intervention may help reduce hospital utilization in patients undergoing radiation with or without chemotherapy for head and neck cancer.

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Eligible Conditions

  • Head Neoplasms
  • Head and Neck Neoplasms
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Symptom Assessment will improve 2 primary outcomes and 6 secondary outcomes in patients with Head Neoplasms. Measurement will happen over the course of Start of treatment to 3 month post treatment completion.

Month 3
Brief Pain Index (BPI)
Emergency Room Visits
Flourishing Measure
Functional Assessment of Cancer Therapy for Head and Neck Cancer
Hearing Handicap Inventory for Adults
Inpatient Hospitalizations
M.D. Anderson Symptom Inventory for Head and Neck Cancer
Tinnitus Handicap Inventory

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Head and neck cancer patients

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Symptom Assessment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Head and neck cancer patients
Behavioral
Patients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: start of treatment to 3 month post treatment completion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly start of treatment to 3 month post treatment completion for reporting.

Who is running the study

Principal Investigator
M. N.
Prof. Marci Nilsen, Assistant Professor Acute & Tertiary Care
University of Pittsburgh

Closest Location

Eye and Ear Institute - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, an evaluation will be done to ensure that the patient qualifies for the treatment show original
The patient's cancer will include squamous cell carcinoma that has spread to their lymph nodes, but the original cancer's location is unknown. show original
Age 18 and older
The individual was diagnosed with a type of cancer that starts in the squamous cells in the areas of the paranasal sinuses, nasal cavity, oral cavity, tongue, salivary glands, larynx, and pharynx show original
The Hillman Cancer Center provides treatment for a variety of cancers show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is head neoplasms?

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Tumors of the head and neck are a spectrum of malignant neoplasms. Many, and perhaps most, are benign in origin. The differential diagnosis of malignant head and neck neoplasms requires careful clinical observation.

Unverified Answer

What are common treatments for head neoplasms?

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Results from a recent paper provides evidence to guide clinicians and patients in selecting and choosing the most appropriate therapy for specific head and neck malignancies.

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Can head neoplasms be cured?

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This retrospective analysis of patients with brain metastases showed no correlation between tumor size, number or the tumor fraction of necrosis and prognosis. More studies are needed to assess the prognostic value of tumor number and the fraction of necrosis in individual patient cases.

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What causes head neoplasms?

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The three most frequent tumors of the central nervous system originate from brain stem cells (glial tumors and gliomas, astrocytomas, oligodendrogliomas and oligoastrocytomas), whereas malignant astrocytoma and parenchymal tumors originate from neuronal progenitor cells.

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How many people get head neoplasms a year in the United States?

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A total of 521,000 people per year will see an orthopedic surgeon with a primary head and neck tumor at some point. In the United States, there were 278,000 persons with primary head, neck, and cranial cavity tumors seen at some time in 2018 (2.1 tumors per 1,000 persons in the overall U.S. population).

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What are the signs of head neoplasms?

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Head and neck lesions can often be observed on imaging studies performed for other indications. Data from a recent study warrant further investigation if they are suggestive of a lesion. For lesions suspected to be malignant or premalignant in nature, more invasive investigation and histological analysis should be ordered to obtain a definitive diagnosis.

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What are the chances of developing head neoplasms?

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In contrast to cervical spine and brain cancers, there is no increased risk for developing head neoplasms. The risk is lowest among men and women with more than 60 years of age with the highest risk being in those older than 90 years. There was no increase in risk of developing head neoplasms in either current or former smokers. This is in contrast to cervical stenosis and brain gliomas.

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What is the primary cause of head neoplasms?

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It is evident from this study that many of the head and neck cancers which were diagnosed were related to occupational exposures. These data imply that head and neck neoplasms may have a multifactorial etiology and prevention policies could result in reduced rates of these malignant tumors in the future.

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What are the latest developments in symptom assessment for therapeutic use?

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The present studies illustrate how information provided by a patient to his/her clinician can lead to an improvement in symptom assessment and also change treatment decisions.

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Have there been other clinical trials involving symptom assessment?

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Patients with symptom assessment in the clinical trial setting have more than twice the probability of being included in a clinical trial. A protocol for symptom assessment in clinical trials to be required for all clinical trial sites to assess this symptom in CLL patients.

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How serious can head neoplasms be?

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Although serious head neoplasms are rare, their morbidity is highly significant. However, patients suffering from head neoplasms often have long-lasting morbidity, including persistent neurological and neuro-ophthalmic deficits from the primary brain tumor, headache and/or cranial nerve dysfunction related to local recurrence, and progressive visual/hearing impairment and/or cognitive dysfunction from the metastatic disease.

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Is symptom assessment typically used in combination with any other treatments?

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Only a very small percentage of participants reported that symptom assessment is used in combination with another treatment (e.g., surgery, chemo, [immunotherapy](https://www.withpower.com/clinical-trials/immunotherapy), or radiation therapy). When assessing symptom distress related to cancer, it is important to first make sure the patient has been given any information that might alter the patient's response and to ask questions that target the patient's symptom concerns.

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See if you qualify for this trial
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