CLINICAL TRIAL

Six Week Physical Activity Intervention for Malignancies

Stage III
Waitlist Available · 18+ · All Sexes · Tampa, FL

This study is evaluating whether a home-based physical activity program can improve symptoms and physical function among patients with advanced stage cancer.

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About the trial for Malignancies

Treatment Groups

This trial involves 2 different treatments. Six Week Physical Activity 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.
Six Week Physical Activity Intervention
BEHAVIORAL
Progress Reporting
OTHER
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 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
They have fatigue and/or two other target symptoms. show original
The person has been diagnosed with stage III or IV cancer. show original
able to understand English
Their KPS score is 60%, meaning they are able to care for most of their personal needs. show original
They are allowed to do physical activities that are low to moderate intensity. 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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 weeks per participant
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks per participant
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 weeks per participant.
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 Six Week Physical Activity Intervention will improve 1 primary outcome and 1 secondary outcome in patients with Malignancies. Measurement will happen over the course of 6 weeks per participant.

Rate of Participation Among Eligible Patients
6 WEEKS PER PARTICIPANT
Feasibility and acceptability of a tailored Wii Fit intervention. Hypothesis1.1: 60% of eligible patients will enroll; 1.2: 60% of participants will adhere to their tailored physical activity prescriptions; 1.3: 70% of participants will agree that Wii Fit is easy to use, enjoyable, convenient, and helpful. Enrollment rate: ratio of number of advanced stage cancer patients enrolled in the study to total number of patients meeting eligibility criteria invited to participate in the study. Adherence rate: ratio of the number of participants who adhere to the tailored Wii Fit prescription (i.e., expend at least 60% of prescribed kilocalories each week) to the total number of participants in the study. Acceptability of and satisfaction with the intervention: ratio of number of participants whose mean scores of Wii Fit and RN Visiting Surveys are equal to or more than 3 on 1-4 Likert-type scale to the total number of participants in the study.
6 WEEKS PER PARTICIPANT
Rate of Positive Response to Participation
6 WEEKS PER PARTICIPANT
Examine changes in outcomes (fatigue, pain, depression, anxiety, sleep quality, physical function, perceived stress, and chronic Hypothalamus-Pituitary-Adrenal (HPA) activation) over 6 weeks among patients who have the intervention. Hypothesis 2.1: There will be positive changes in the outcomes. Repeated measures ANOVA will be used to compare T1 with T2 scores in fatigue, pain, depression, anxiety, sleep quality, physical function, perceived stress, and hair cortisol. Twenty participants will provide 80% power to detect only large effect sizes (d>.60), which cannot be anticipated. Because the purposes of this study are to inform future larger studies, the ANOVA will be used to calculate effect sizes (η2) for future power estimations. Because effect size calculation will be the central purpose of the ANOVAs, no adjustment will be made to reduce the possibility of Type 1 errors (p<.05).
6 WEEKS PER PARTICIPANT

Patient Q & A Section

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

How serious can malignancies be?

malignancies do happen, however, most people of all ages can be expected to live with their tumour. It is important to talk to patients about the impact of their disease. It is crucial that staff know exactly what people are getting from their treatment and can reassure patients about the course of their illness.

Anonymous Patient Answer

What are common treatments for malignancies?

The common treatment includes first-, second-, and third-line chemotherapy in the form of anthracyclines, alkylating agents, and carbapenems, as well as targeted agents such as EGFR inhibitors, PI3K/AKT/mTOR inhibitors, anti-HER2 antibodies, and anti-VEGF agents. Although, the choice of agents is highly individualized, the majority of patients in the studies we investigated have received the three drugs listed above in the typical order of therapy.

Anonymous Patient Answer

What is malignancies?

A great number of patients develop cancer, most commonly of the respiratory system, breasts, and colon when they were children. The causes of cancer vary between different age groups, with the greatest number of cases in the early teens when tobacco, alcohol, and various other factors exert their effects on development.

Anonymous Patient Answer

How many people get malignancies a year in the United States?

About 14 million persons were diagnosed in 2007 with one of the 28 malignancies examined in this study. Each year, around 6.8 million new cases are diagnosed with 1 of the 28 malignancies. These malignancies are predominantly solid tumors, which accounted for 79% of the newly diagnosed cases. The other 1st malignancies, non-melanoma skin cancer, and breast cancer in females, and non-Hodgkin lymphoma in males, were the most frequent malignancies in women (about 80% of the detected cases), while Kaposi sarcoma was the most frequent malignancy in men (about 60% of newly diagnosed cases).

Anonymous Patient Answer

What are the signs of malignancies?

Abnormal heart rate, fever, vomiting and erythema are the first signs of neoplasms. On palpation, enlargement, or roughness of the liver might indicate pancreatic carcinoma; enlargement, or pain in the chest, flank, or back might be signs of lung cancer; and enlarged spleen or lymph nodes might signify lymphatic malignancies.

Anonymous Patient Answer

What causes malignancies?

The causes of malignancies can be divided into acquired malignant neoplasms (tumours and cancer) and germ-line changes which include heritable genetic disorders and genetic mutations, chromosomal rearrangement, and errors in mitosis.\n

Anonymous Patient Answer

Can malignancies be cured?

There are many instances of patients being cured of cancers (for example, the case of the Hodgkin disease patients) even if the disease was in its earliest stages or if they are well-matched at the individual level, but only rarely are patients cured when treated with more radical and less successful methods (for instance when the cancer cannot be cured in the most effective manner). In general, there is much more to say about patients with cancer when the disease is cured. However, it is important always to say that the treatment used, and especially more radical and less successful methods, can result in an insufficiently effective treatment.

Anonymous Patient Answer

Is progress reporting typically used in combination with any other treatments?

Given the progress report's importance in informing patients and clinicians, there is a clear and urgent need for the use of reporting instruments in the context of routine clinical practice to promote the correct and systematic reporting of progress.

Anonymous Patient Answer

What is the average age someone gets malignancies?

Age at diagnosis of malignancy can be affected by factors such as sex, race, marital status, medical care coverage, and tumor type. The age distribution of malignancy is affected by racial barriers. The [Cancer Incidence in the United States: Trends in the 1950s, 1960s, 1970s and 1980s (1985-1988)] study, done in the United States, showed that there were more people with cancer diagnosed every year from 1985-88 compared to the 1950s, 1960s, and 1970s. This was an increase of 4 million yearly cancer cases over the same time period. But what is the average age someone gets malignancy? For breast cancer the average age was 64.

Anonymous Patient Answer

What is progress reporting?

Most studies reported short and long-term progress made, yet there was little information that could help patients make informed decisions about the benefit and harms of their clinical trials in terms of treatment choice. Results from a recent clinical trial highlights the needs of patients and investigators for information in reporting trials and suggests ways to make it better - and maybe a mandatory reporting tool for all clinical trials.

Anonymous Patient Answer

What is the latest research for malignancies?

The [www.medlinexchange.com] search strategy provided accurate and reliable information about cancer research. Understanding the literature at a glance allowed us to quickly find most recent clinical trials and summarize information about new cancer drugs and treatments.

Anonymous Patient Answer

What are the latest developments in progress reporting for therapeutic use?

Reporting for active clinical trials is a constant and vital part of good evidence based medicine and ensures transparency of the scientific process. The WHO Statement encourages all healthcare providers to engage in good evidence based medicine. The current progress report of a randomized trial compares a number of widely used chemotherapy agents against a placebo. This randomized trial will be followed up over the next 5 years with a progress report to ensure all questions are addressed. The trial may hopefully lead to a change in treatment decisions.

Anonymous Patient Answer
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