CLINICAL TRIAL

A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) for Head Neoplasms

Recruiting · 18+ · All Sexes · Tampa, FL

This study is evaluating whether a new intervention may help improve physical activity and quality of life for individuals who have had head and neck cancer.

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About the trial for Head Neoplasms

Eligible Conditions
Head and Neck Cancer · Head and Neck Neoplasms

Treatment Groups

This trial involves 2 different treatments. A Personalized Physical Activity Intervention With Fitness Graded Motion Exergames (PAfitME) 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.
A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
diagnosed with head and neck cancer (Tumor sites in the head and neck area);
18 years or older;
able to understand English;
able to communicate;
have a Karnofsky Performance Status (KPS) score of >= 60%;
be cleared by their provider to resume low to moderate intensity PA;
have fatigue or pain of ≥moderate severity;
A KPS score of >= 60% has been used in previous exercise trials in the HNC population. This is equal to ECog scores ≤ 2.
Moderate fatigue or pain severity is defined as a worst score in the past week of >= 4 on a 0-10 scale.
Patients receiving immunotherapy are not excluded from participating in the study.
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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: Week 0 and Week 6
Screening: ~3 weeks
Treatment: Varies
Reporting: Week 0 and Week 6
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 0 and Week 6.
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 A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME) will improve 2 primary outcomes and 8 secondary outcomes in patients with Head Neoplasms. Measurement will happen over the course of Baseline and Week 6.

Objective Functional Status will be measured by 2-minute walk test.
BASELINE AND WEEK 6
The 2-minute walk measures distance (in meters) walked in 2 minutes. The distance in meters will will be calculated in the analysis to test the changes from baseline to week 6.
BASELINE AND WEEK 6
Fatigue will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue (NIH Common Data Elements [CDE]).
BASELINE AND WEEK 6
In the PROMIS Short Form v1.0-Fatigue, the 6 items ask about fatigue status, including fatigue severity and fatigue distress in the past 7 days. The scale ranges from 1 to 5. The higher the score, the worse the symptom. The mean score of 6 items will be calculated in the analysis to test the changes from baseline to week 6.
BASELINE AND WEEK 6
Musculoskeletal Pain will be measured by the PROMIS Short Form v.1.0-Pain Intensity (CDE).
BASELINE AND WEEK 6
In the PROMIS Short Form v1.0-Pain, the 3 items ask about pain intensity in the past 7 days. The scale ranges from 1 to 5. The higher the score, the worse the symptom. The mean score of 3 items will be calculated in the analysis to test the changes from baseline to week 6.
BASELINE AND WEEK 6
Subjective Functional Status will be measured by the self-report Lawton Instrumental Activities of Daily Living Scale (IADL).
BASELINE AND WEEK 6
In the IADL, the 8-item IADL measures dependence/independence of 8 daily activities. Participants will respond based on their highest level of independence for that activity. The total score ranges from 8 to 31. The higher the score, the better the function. The toal score of 8 items will be calculated in the analysis to test the changes from baseline to week 6.
BASELINE AND WEEK 6
Objective Functional Status will be measured by upper extremity range of motion (ROM).
WEEK 0 AND WEEK 6
Upper extremity ROM is upper extremity flexibility and includes shoulder abduction, shoulder forward flexion, neck forward flexion, neck extension, neck lateral flexion, and neck lateral rotation. The ROM will be measured by a plastic 12" goniometer 360 degree (Szy Holdings LLC, Brooklyn, NY). The degrees of range of motion will be calculated in the analysis to test the changes from baseline to week 6.
WEEK 0 AND WEEK 6
Quality of Life will be measured using the Functional Assessment of Chronic Illness Therapy-Head and Neck Scale, version 4 (FACIT-H&N).
WEEK 0 AND WEEK 6
FACIT-H&N includes a 28-item general scale and a 12-item HNC scale. The scale ranges from 0 to 4. The greater the score, the better the quality of life. The mean scores of the 28-item general scale and 12-item HNC scale will be calculated in the analysis to test the changes from baseline to week 6.
WEEK 0 AND WEEK 6
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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?

Head neoplasms are tumors that form in the scalp and neck and include almost any type of cancer. Many head and neck cancers grow back, and can recur or metastasize. However, metastases to the brain from head and neck cancer are very rare. Treatment includes surgery, radiation therapy, and chemotherapy.

Anonymous Patient Answer

What causes head neoplasms?

The most common types of brain tumors are gliomas, primitive neuroectodermal tumor, medulloblastoma, and ependymoma and are mostly sporadic. Oncogenes play a crucial role during the process of tumorigenesis. The most studied are the "Notch-1", which plays a role in tumorigenesis and the "c-myc" oncogene, whose loss of function is associated with benign neoplasms, the "p16" tumor suppressor gene, an important candidate for the genesis of both, medulloblastomas and ependymomas.

Anonymous Patient Answer

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

About 1,300,000 [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer)s are diagnosed annually in the United States, making it the most common cancer in American men and women. The most-common form are laryngeal cancer and pharyngeal cancer, which together account for 90% of all head and neck cancer cases. The incidence of head and neck cancer has been on the increase steadily since the 1950s; however, the annual age-adjusted and age-standardized incidence of head and neck cancer decreased slightly between the 1971-80 period and the 1990-99 period. The decline was greatest in the more educated and higher income-level segments of the population, particularly in the whites.

Anonymous Patient Answer

What are the signs of head neoplasms?

Most head tumors have nonspecific symptoms; often these symptoms mimic psychiatric or neurological disorders. It is particularly critical for neurologists to recognize headache as a symptom of neoplastic brain disease or neurosurgical pathology.

Anonymous Patient Answer

Can head neoplasms be cured?

Although patients with cancer of the head may experience many problems, in particular, the loss of their sense of smell, the majority of patients with brain and spinal tumors can live happily with their disease, without the morbidity of having the disease but can continue to function normally. The same can be said of patients with craniac tumors. If cancer is discovered, however, treatment options are limited. The best method of management is to wait and see if a tumor develops or not, and to continue to take anticancer drugs as appropriate. This will be a major advance in our future management of this group of patients.

Anonymous Patient Answer

What are common treatments for head neoplasms?

There are few common treatments for head neoplasms. However, radiation therapy and surgical removal of the tumor or partial removal of it are some of the commonly used treatments for the prevention or relief of headaches.\n

Anonymous Patient Answer

What is a personalized physical activity intervention with fitness graded motion exergames (pafitme)?

A personalized physical activity intervention with fitness graded motion exergames is a feasible approach to increase physical activity in clinical populations. More work on individualized exercise prescription is warranted, especially to decrease the risk for developing obesity and preventing cancer.

Anonymous Patient Answer

Does head neoplasms run in families?

Results from a recent clinical trial indicate that this high frequency of neoplasms is due to a probable genetic predisposition, inherited from a common ancestors, which is not limited to head neoplasms.

Anonymous Patient Answer

Who should consider clinical trials for head neoplasms?

The American Head and Neck Cancer Foundation has developed and is implementing an [Internet web site that provides] [information, tools, and resources for assessing patients' interests in clinical trials of head and neck cancer]. The website includes questions pertaining to current head and neck treatment and encourages individuals to take a [health care provider]]s opinion about whether they are right for clinical trials related to head and neck cancer or if they should consider joining clinical trials.

Anonymous Patient Answer

What are the chances of developing head neoplasms?

Recent findings, the calculated lifetime probability of developing head neoplasms after initial treatment of a first brain tumor was 5.7 per 1000. The lifetime chance of developing brain metastases after resection of an intracranial brain metastasis was estimated to be 7.2 per 1000. The lifetime probability of developing cranial meningioma with extracerebral primary was estimated at 11.8 per 1000. When the probability of developing secondary primary head neoplasms is considered with the initial occurrence of brain metastasis, the net lifetime probability for secondary benign brain neoplasms may be as high as 19.6 per 1000.

Anonymous Patient Answer

How does a personalized physical activity intervention with fitness graded motion exergames (pafitme) work?

The intervention was feasible and was well accepted by participants. The findings and suggestions from this study will help clinicians and researchers to develop more valid and reliable instruments to measure exercise behaviours. The design of the study is a unique and attractive addition to the emerging exergames sector.

Anonymous Patient Answer
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