Effect of monthly cancer intervention newsletters on cancer patients treatments

     

    write a proposal from the document provided (the ethics form detailing the study).

    write a 3 page proposal using the details of the research study in the ethics form

     

    Application to the Research Ethics Board
    Department: Masters of Public Health (Health Studies)
    Title: A study of the effect of monthly cancer intervention newsletters on patients treatment methods

    Summary of purpose of research
    Be sure to include sufficient detail, described in terms that do not require extensive field-specific knowledge (similar to the statement you would prepare for a granting agency for public dissemination).
    The proposed research is intended to compare the potential effect of using latest discovery versus traditional long term more used methods or approaches to treating cancer. This experiment is designed to provide information in the form of news letters to specialists about the latest discoveries, and looking at its indirect effect on patient’s quality of life.

    Research methodology
    This research will attempt to recruit 40 Oncologists. Using 40 patient records per oncologists in Ontario. Totalling 1600 cancer patients diagnosed with (400) Lung, (400-200 female, 200 male) Colorectal, (400 female) Breast and (400 male) Prostate cancer. (Use stats document to show these are the most common diagnosed cancers).
    The specialists will be contacted through phone in the Hospital/doctor search network. Patient will fill out a consent form (attached) to let us use their records for this experiment. The participants are only expected to agree to provide us with their medical records during the five years of this clinical trial research. The patients are selected from the age range of 50-70 years.
    Breast cancer occurs primarily in females 50–69 years of age. Thirty percent of breast cancer cases will be diagnosed among women over the age of 69, while 19% will occur in those under age 50 (https://www.cancer.ca/Canada-wide/About%20cancer/~/media/CCS/Canada%20wide/Files%20List/English%20files%20heading/PDF%20-%20Policy%20-%20Canadian%20Cancer%20Statistics%20-%20English/Canadian%20Cancer%20Statistics%202012%20-%20English.ashx)
    This study will be run for a duration of five years. Once the data is fully collected, analysis of variance methods will be used to investigate the existence of the mentioned effect.

    Recruitment procedures
    Specialitst are recruited voluntarily over the phone, a consent form will be sent to those willing to take part in the study. Specialists and are expected to provide us with their patient records after their patients have agreed to confidential sharing of their information. Through these patient records
    The proposed qualitative study will consist of two Phases. The first phase will involve the researcher sending potential participants (specialists) a published article to read which concisely describes new therapies, interventions and drugs available now that can be used to update themselves with caring for their patients.

    During the second phase, participants will be asked to complete a small questionnaire and include a copy of (some of their) patient records. A patient consent form (attached) will also be provided to them to let us get their patient (limited) records. The patients will all have more or less the same conditions, even if there are small differences, they will cancel out because of the large number of patients.

    The specialists in the experiment group will be provided with the latest up to date information on the cancer, in the form of newsletter, etc. The control group will not receive anything.

    Harm and/or potential risks to participants
    According to the fully non-invasive type of the intervention (providing latest research advances to the specialists), there are absolutely zero potential harm to the participants. The third parties, which are the patients of these participants, are also not exposed to any type of harm because it’s only their records which will be used for this study.
    Deception
    This experiment does not involve any deception.
    Benefits to subjects and/or society
    The specialists will be up to date with the latest research information in the area of cancer research. In turn, this research will indirectly affect their patients since their physicians will be updated and familiar with the most recent discoveries for treating cancer.
    Informed consent
    To ensure consent form from each participant in this study, after (a
    visit or a phone call success) that they are interested in our
    research. I will send them a package with a cover letter describing
    the intention of this research project briefly. Also there will be an
    attached consent form, indicating that by signing they agree to
    participate and that they understand the information contained in the
    cover letter.
    As mentioned earlier, only patients in the age range of 50-70 years are asked to participate in this study, so there are no participants under the age of consent.
    All participating specialists, as well as their patients, will be sent a cover letter (attached), and a consent form (attached), written in accordance with the ethics board guidelines. Participants will all be asked to sign the consent form prior to research commencing.
    Anonymity and confidentiality
    Although the overall conclusions will be used in the final report of the results, direct records from the patients, as well as all other information gathered from the specialists or their patients will be securely locked during data collection, data analysis, and report writing.
    Storage of data
    The duration of the experiment is about five years. All collected data will be stored in the Public Health Department at . University during the experiment, as well as eight years after finishing the experiments.
    Peer review
    A peer review is not applicable for this study.
    Research partners and graduate students
    This study will not involve graduate students or researchers at another university or institution.

    Conflict of Interest
    This study has no actual, perceived or potential conflicts of interest.

    Dissemination of research results
    All research participants will be informed during the consent process that study findings will be available to them and at their request. Participants will be provided with the phone number and email for the researchers on both the consent form, cover letter, and the phone calls. The website of the project will also be provided, where the progress of the project will be reported regularly. The participants will be given an approximate date of completion and instructed to contact the researchers should they wish to receive a copy of the results. Academic community members may also contact the researchers directly for study results. It is intended that research findings will be submitted for publishing, as well as being used in the future studies.

    Cover letter
    There will be two cover letters used in this study: One for the specialists, and the other for their patients where their medical records are going to be used in this research study.

    Cover letter for specialists:
    Dear Potential Participant:
    I am conducting a study of the effect of monthly cancer intervention newsletters on patients treatment methods. This study is an analysis using data collected from the records of the patients of the specialists participating. The intent of this research project is to understand the relation between having up to date cancer specialists and the quality of their patients treatments and results.
    To accomplish this goal, we would like you to consent to the release of the following information from your patients records: I) Age, II) Gender, III) Height & Weight, IV) Overall details of the cancer treatment, and V) Details of the patients health conditions. Your name, as well as your patients names will not be recorded with the data.
    All information provided will be collected only by myself. It will remain strictly confidential and be securely stored at . University for ten years. The findings of this project will be made available at your request upon the completion of the project.
    Thank you for your cooperation,
    . .

    Cover letter for patients:
    Dear Potential Participant:
    I am conducting a study of the effect of monthly cancer intervention newsletters on patients treatment methods. This study is an analysis using data collected from the records of the patients of the specialists participating. The intent of this research project is to understand the relation between having up to date cancer specialists and the quality of their patients treatments and results.
    To accomplish this goal, we would like you to consent to the release of the following information from your medical records: I) Age, II) Gender, III) Height & Weight, IV) Overall details of your cancer treatment, and V) Details of the your health conditions. Your name will not be recorded with the data.
    All information provided will be collected only by myself. It will remain strictly confidential and be securely stored at . University for ten years. The findings of this project will be made available at your request upon the completion of the project.
    Thank you for your cooperation,
    . .

    Consent forms
    As mentioned earlier, there will be two consent forms for this study: One for the specialists, and one for the patients. The consent form for the patients will be provided to the specialists, so they can choose from their patients for this study, and will be collected back from them before starting the study.

    Consent form for the physicians:
    I __________________have read the cover letter regarding: The effect of monthly cancer intervention newsletters on patients treatment methods. I am aware of the purpose of the study and that I have a right to refuse to answer any question and to stop my participation in the study at any time. I am aware that I may be receiving some newsletters about the latest research advances in the area of cancer treatments, and provide some of the details of my patients as mentioned in the cover letter. I realize that . University will store any data collected for ten years and the completed report will be available to the public. I am aware that I can access the report in January 2017 from . ..
    In signing below I agree to participate in the study.

    ________________________________________
    Signature Date

    Consent form for the Patients:
    I __________________have read the cover letter regarding: The effect of monthly cancer intervention newsletters on patients treatment methods. I am aware of the purpose of the study and that I have a right to refuse to answer any question and to stop my participation in the study at any time. I am aware some of the details of my treatment progress will be provided to the researchers. I realize that . University will store any data collected for ten years and the completed report will be available to the public. I am aware that I can access the report in January 2017 from ….
    In signing below I agree to participate in the study.

    ________________________________________
    Signature Date

     

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