CLINICAL TRIAL

Behavioral Intervention for Head Neoplasms

Recruiting · 18+ · All Sexes · Philadelphia, PA

This study is evaluating whether a physical activity program is safe and tolerable for head and neck cancer patients.

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About the trial for Head Neoplasms

Eligible Conditions
Stage II Laryngeal Cancer AJCC v8 · Oral Cavity Carcinoma · Stage I Laryngeal Cancer AJCC v8 · Stage IVC Laryngeal Cancer AJCC v8 · Paranasal Sinus Carcinoma · Stage III Laryngeal Cancer AJCC v8 · Laryngeal Neoplasms · Laryngeal Carcinoma · Carcinoma · Head and Neck Neoplasms · Head and Neck Carcinoma · Hypopharyngeal Carcinoma · Sinonasal Carcinoma · Maxillary Sinus Carcinoma · Lung, Carcinoma · Oropharyngeal Carcinoma · Stage IVA Laryngeal Cancer AJCC v8 · Stage IV Laryngeal Cancer AJCC v8 · Stage IVB Laryngeal Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Behavioral Intervention 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Questionnaire Administration
OTHER
Behavioral Intervention
BEHAVIORAL
Exercise Intervention
OTHER
Medical Device Usage and Evaluation
OTHER
Consultation
OTHER
Quality of Life Assessment
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Questionnaire Administration
OTHER
Medical Device Usage and Evaluation
OTHER
Consultation
OTHER
Quality of Life Assessment
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2017
Completed Phase 4
~3170

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The individual has been cleared by their oncologist to participate in an aerobic and resistance exercise intervention. show original
are two of the main reasons for high levels of engagement with the internet Some people believe that having access to a smartphone and having an active wi-fi connection at home are the main reasons for high levels of engagement with the internet. show original
with pembrolizumab A person with head and neck cancer, including cancers of the sinuses, oral cavity, oropharynx, hypopharynx, or larynx (all stages), is therapeutically eligible to receive at least three months of immunotherapy with pembrolizumab. show original
The person can understand and sign a written informed consent form, and they have no cognitive decline. show original
Women of reproductive potential must have a negative serum or urine pregnancy test within the week prior to starting therapy
A person who is 18 years old or older is legally allowed to vote. show original
Able to read and/or to speak English fluently. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 12 weeks after physical activity promotion
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 12 weeks after physical activity promotion
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 12 weeks after physical activity promotion.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Behavioral Intervention will improve 2 primary outcomes in patients with Head Neoplasms. Measurement will happen over the course of Baseline to 12 weeks after physical activity promotion.

Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
BASELINE TO 12 WEEKS AFTER PHYSICAL ACTIVITY PROMOTION
Changes in physical activity of the control group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
BASELINE TO 12 WEEKS AFTER PHYSICAL ACTIVITY PROMOTION
Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day
BASELINE TO 12 WEEKS AFTER PHYSICAL ACTIVITY PROMOTION
time trend will be compared between control and intervention groups at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models
BASELINE TO 12 WEEKS AFTER PHYSICAL ACTIVITY PROMOTION

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 are common treatments for head neoplasms?

There are many options for treatment of a wide variety of head and neck head and neck neoplasms. Treatment options can be broadly grouped into 3 main strategies. These strategies are resection, irradiation and chemotherapy. The decision will vary depending on many factors such as local and regional health care system.

Anonymous Patient Answer

What is head neoplasms?

The most common malignant tumors from the head and neck are adenocarcinomas. Malignancies of the nasal sinuses, paranasal sinuses and the base of the skull, as well as meningiomas of the brain and the spinal cord, are all frequently seen in this group. The tumors, particularly those of the skull base, usually require surgical intervention due to the possibility that they may become life-threatening. Malignant brain tumors are now more frequently diagnosed in the developing world. The prognosis for brain cancer patients, which is largely based on their age and condition at the time of diagnosis, is often unfavorable.

Anonymous Patient Answer

Can head neoplasms be cured?

This analysis suggests that there may be a role for cancer chemotherapy in reducing the incidence and severity of the most common complications in this group of patients. However, as there was no information available on prognosis and morbidity, the results require further investigation before they are accepted.

Anonymous Patient Answer

What causes head neoplasms?

Different tumors are found in different regions of the head, and the risk factors seem to be affected in various ways. The most frequent tumors are meningiomas, chondrosarcomas, and gliomas. They are also more likely to occur in the posterior cranial fossa. Different environmental factors may be involved in the etiology of different types of head tumors.

Anonymous Patient Answer

What are the signs of head neoplasms?

The most common signs of head neoplasms are headache, fever, photophobia, vomiting and weight loss. Less common signs are seizure and hearing loss. Coughing due to recurrent airway infections also may occur. The diagnosis of head neoplasms should be suspected in elderly subjects with unexplained headaches who present with a mass or lymph node abnormality. CT is essential for diagnosis. Clinicians should be aware of the potential for cancer or blood disorders to present with unexplained,

Anonymous Patient Answer

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

There are more than 3 million new cases of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) occurring each year in the United States. Nonmetastatic primary brain cancers accounted for over 95% of these cases. The mortality rate was significantly increased by race, advancing age, and lower education status.

Anonymous Patient Answer

Does head neoplasms run in families?

All the head and neck squamous cell carcinomas that appear to be attributable to head neoplasms were found to be sporadic. There seems no evidence that these are hereditary cancers. Nevertheless, it is recommended that persons who have a family history of head or neck neoplasms should consider undergoing a thorough medical history and genetic testing and regular screening with a primary care professional to help identify anyone with a family history of such neoplasms before a definitive diagnosis of either type is made.

Anonymous Patient Answer

How quickly does head neoplasms spread?

A few factors influencing tumor diffusion and tumor growth have been outlined. This model helps estimate the tumor behavior if it is known that there is a tumor in a brainstem location.

Anonymous Patient Answer

What is the primary cause of head neoplasms?

Results from a recent paper confirmed that men are 3.5 times more likely to have head neoplasm compared with women. The risk of primary brain carcinoma is highest in the first 7 years of life in women, and is 2.6 times higher in young adult and elderly men. The risk is highest in men of Caucasian origin.

Anonymous Patient Answer

What are the latest developments in behavioral intervention for therapeutic use?

Behavior therapy can be effective in reducing relapse and, in some subjects, in achieving remission from depression. However, more research in randomised control trials is required before this intervention is recommended in head and neck cancer.

Anonymous Patient Answer

How serious can head neoplasms be?

With respect to neurological and mental states, those suffering from head neoplasms were most at risk of persistent neurological disability, and those with psychiatric and social problems were at greatest risk of persistent cognitive deficit.

Anonymous Patient Answer

What does behavioral intervention usually treat?

Most of the patients in our study had chronic pain and psychological consequences of cancer treatment. A multidisciplinary approach with the participation of psychologist and nurse is needed to provide palliative care.

Anonymous Patient Answer
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