Question

Write proposal that describes an assessment of the needs of the client(s) and why you feel this project would be beneficial to improve health outcomes. Include the goal of the project, the target audience, and what you expect the response to be.

This proposal must be at least 2 pages in length, not counting the cover page and reference page, and be appropriately cited in APA format.

Answer 1

Project Title: ‘Effects of Heartfulness Meditation on genetic expression of cancer patients- a randomized controlled trial’

Project Summary:

An individual diagnosed with cancer have much impact on one’s self, family, and friends and in even caregivers. Diagnosing cancer ends with a completely life-changing experience. Physical and psychological symptoms such as pain, nausea, fatigue, the feeling of grief, fear and anxiety, fear of death etc. Even the family members and caregivers have the fear of losses and changes in their lives. People with cancer often feel depressed and have to face the self-image issues related to the treatment e.g. Chemotherapy. Almost all the cancer patients along with their family were stressful. During stress, the systemic nervous system triggers fight or flight response to increasing the production of nuclear factor- Kappa B [NF-kB] which is responsible for the regulation of gene expression to translate stress by the production of proteins called cytokines which cause inflammation in cellular level. It is beneficial if persists for a shorter duration and for a longer duration, prone to cancer, depression and other inflammation-related disorders. Infectious and non-infectious chronic inflammation leads to the progression of cancer. In the other hand, NF-kB gets induced by chemotherapy. As a part of cancer treatment, NF-kB inhibitors were used which also adds the risk that it can be detrimental due to its resistance to chemotherapy and its essential role in innate immunity. Recent researchers proved the benefits of Meditation in handling the stress and depression in a positive way and thereby reduce the production of NF-kB and other inflammatory markers responsible for cancer incidence. Hence we want to assess the effectiveness of Heartfulness Meditation in genetic expression of cancer patients who receive chemotherapy.

Keywords: Cancer, Inflammatory markers, nuclear factor - Kappa B, chemotherapy and Heartfulness Meditation

Introduction and need for the study:

NF-kB factor plays a pivot role in innate and adaptive immunity, inflammation, proliferation and death of cells. NF-kB signaling pathways are responsible to the cancer evolvement and its progression, response to treatment such as chemotherapy, radiotherapy, and pharmacological therapy.

In economic countries, the leading cause of mortality is cancer. Even in modern times, there is much advancement in detection and treatment modalities, still, cancer remains irremediable. When considered cancer, it is not one, it has manifold in its characteristics and treatment modalities. The biggest challenge in treating cancer is to understand and differentiate the epigenetic alterations and mutations of cancer genes which involved in disruption of normal processes. The one such big challenge was to differentiate irrelevant changes associated with cancer genotypes. These disruptions depend on the microenvironment of surrounding malignant cell. Mostly, the microenvironment is of inflammatory in nature. Thus the major role played by microenvironment gave us opportunities to innovate intervention targeting the inflammatory elements rather than proliferating cells, in order to prevent resistance to treatment ^[1-5].

Activation of NF-kB is involved in many inflammatory diseases like Asthma, Rheumatoid Arthritis, Bowel diseases, Atherosclerosis, Alzheimer’s disease, variety of human cancers etc. Activation of NF-kB plays an essential role in the pathogenesis of all inflammatory diseases. Irregularities in NF-kB pathway resulting in a variety of malignancies such as leukemia, lymphoma, solid tumors including breast, prostate, ovarian and colon cancers ^[6-23].

Inflammatory markers such as Interleukin-6, C - reactive protein, and Tumor necrosis factor-? level found to be associated with increased cancer risk even in healthy aging. We also want to assess the relationship between the levels of inflammatory markers in response to treatment and cancer prognosis.

There is disinclination in using the NF-kB inhibitors for treating cancer of certain types as it inhibits the efficacy of chemotherapy and even resistance in some cases. In reciprocity, the NF-kB inhibition resulting in enhancement of apoptosis activity in response to radiation ^[24-29].

Keeping all in mind the beneficial terms of reduction in NF-kB production and the possible undesirable effects of NF-kB inhibitors, we would like to intervene with Meditation through Heartfulness and assess its efficacy in reduction of NF-kB and to bring the desirable genetic expression in cancer patients.

Statement of the problem

                     “Effects of Heartfulness Meditation on genetic expression of cancer patients- a randomized controlled trial”

Objectives

• To assess the risk of cancer according to their demographics
• To assess the incidence of primary sites of cancer according to their demographics
• To assess the effects of Heartfulness Meditation on genetic expression and inflammatory markers of cancer patients
• To determine the association between the selected demographic variables and the clinical variables

Hypothesis of the study

       H₁: The mean clinical variables of cancer patients will be significantly associated with demographic variables at p < 0.05 level

      H₂: There will be significant association between the selected clinical variables of cancer patients and Heartfulness meditation intervention at p < 0.05 level

Operational definitions

Cancer Patient

A person who is receiving medical treatment for a malignant growth or tumor.

NF-?B

NF-?B (nuclear factor kappa-light-chain-enhancer of activated B cells) is a protein complex that controls transcription of DNA, cytokine production and cell survival.

Delimitation

        The study is delimited to,

• Unwilling to participate
• Patients who don’t receive chemotherapy
• Patients who receive NF-kB inhibitors
• Unwilling to meditate

Assumption

        The study assumes that,

• Cancer patients were more stressful and depressed
• Meditation helps in reduction of NF-kB and other inflammatory markers and thus aids in cancer treatment

Variables

INDEPENDENT VARIABLES

            Variables such as age, average age at cancer diagnosis, geographic location, gender, occupation, religion, type of residence, type of family, Body Mass Index, waist circumference, food pattern, Occasion of outside foods, type of soft drinks, and occasion of soft drinks, primary site of cancer- [Bladder cancer, Breast cancer, Cervical cancer, Colorectal (colon) cancer, Head and neck cancers, Kidney cancer, Leukemia, Liver cancer, Lung cancer, Lymphoma, Myeloma, Ovarian cancer, Prostate cancer, Skin cancer, Thyroid cancer, Uterine cancer, Vaginal and vulvar cancers.]

DEPENDENT VARIABLES

     Interleukin-6 (IL-6), C-reactive protein (CRP), tumor necrosis factor-? (TNF-?) and NF-kB.

Materials and methods

Source of data

        Data will be collected from Cancer patients who are receiving chemotherapy from selected cancer institutes in Chennai.

Method of collection of data

         Diagnostic tests and structured questionnaire

Research design

           An Experimental Research Design

Population

            The population of present study comprises of Cancer patients who are receiving chemotherapy and got admitted in selected cancer institutes in Chennai.

Sample size

           The study is planned to be conducted from the day of approval of funds and continued for a year.

Sampling technique

            Non-probability purposive cluster sampling technique will be used.

Sampling criteria

            INCLUSION CRITERIA  

• Cancer patients willing to participate
• Patients receiving chemotherapy
• Patients who don’t receive NF-kB inhibitors
• Patients willing to meditate for an hour for 6 months

      EXCLUSION CRITERIA

• Unwilling to participate
• Patients who receive NF-kB inhibitors
• Patients who don’t receive chemotherapy
• Unwilling to meditate

Data collection

          It consists of two parts: part I and part II

           Part I: Variables such as age, average age at cancer diagnosis, geographic location, gender, occupation, religion, type of residence, type of family, Body Mass Index, waist circumference, food pattern, Occasion of outside foods, type of soft drinks, and occasion of soft drinks, primary site of cancer- [Bladder cancer, Breast cancer, Cervical cancer, Colorectal (colon) cancer, Head and neck cancers, Kidney cancer, Leukemia, Liver cancer, Lung cancer, Lymphoma, Myeloma, Ovarian cancer, Prostate cancer, Skin cancer, Thyroid cancer, Uterine cancer, Vaginal and vulvar cancers.]

           Part II: Diagnostic tests measuring Interleukin-6 (IL-6), C-reactive protein (CRP), tumor necrosis factor-? (TNF-?) and NF-kB.

Data analysis method

           The data analysis is through descriptive and inferential statistics

• DESCRIPTIVE STATISTICS

Frequency, mean, mean percentage and standard deviation of complete demographic variables.

• INFERENTIAL STATISTICS

Parametric/nonparametric test, chi-square (?²) test applicable for the data will be used to find out the relationship between selected demographic variables and clinical variables among Cancer patients.

Does the study require any interventions to be conducted on patients or other humans or animals?      

            YES – It requires the invasive procedure of collecting blood samples for diagnostic evaluation.

Has the ethical clearance been obtained from your institutions?

    Permission will be obtained from concerned institute ethical committee.

References

1. World Health Organization. Global action against cancer. Geneva, Switzerland: 2005.
2. Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000;100:57–70.
3. Balkwill F, Charles KA, Mantovani A. Smoldering and polarized inflammation in the initiation and promotion of malignant disease.Cancer Cell. 2005;7:211–7.
4. Lin WW, Karin M. A cytokine-mediated link between innate immunity, inflammation, and cancer. J Clin Invest. 2007;117:1175–83.
5. Karin M, Greten FR. NF-kappaB: linking inflammation and immunity to cancer development and progression. Nat Rev Immunol.2005;5:749–59.
6. Tak, P.P., and Firestein, G.S. 2001. NF-?B: a key role in inflammatory diseases.J. Clin. Invest. 107:7–11.
7. Collins, T., and Cybulsky, M.I. 2001. NF-?B: pivotal mediator or innocent bystander in atherogenesis? J. Clin. Invest. In press.
8. Mattson, M.P., and Camandola, S. 2001. NF-?B in neuronal plasticity and neurodegenerative disorders. J. Clin. Invest. In press.
9. Bochner, B.S., Undem, B.J., and Lichtenstein, L.M. 1994. Immunological aspects of allergic asthma. Annu. Rev. Immunol. 12:295–335.
10. Shacter E, Weitzman SA. Chronic inflammation and cancer. Oncology (Huntingt) 2002;16:217–26, 229.
11. O'Byrne KJ, Dalgleish AG. Chronic immune activation and inflammation as the cause of malignancy. Br J Cancer 2001;85:473–83.
12. Hussain SP, Hofseth LJ, Harris CC. Radical causes of cancer. Nat Rev Cancer 2003;3:276–85.
13. Badawi AF, Mostafa MH, Probert A, et al. Role of schistosomiasis in human bladder cancer: evidence of association, aetiological factors, and basic mechanisms of carcinogenesis. Eur J Cancer Prev 1995;4:45–59.
14. Imperial JC. Natural history of chronic hepatitis B and C. J Gastroenterol Hepatol 1999;14 Suppl:S1–5.
15. Williams MP, Pounder RE. Helicobacter pylori: from the benign to the malignant. Am J Gastroenterol1999;94:S11–6.
16. Farrell RJ, Peppercorn MA. Ulcerative colitis. Lancet 2002;359:331–40.
17. Rhodes JM, Campbell BJ. Inflammation and colorectal cancer: IBD-associated and sporadic cancer compared. Trends Mol Med 2002;8:10–6.
18. Malkinson AM, Bauer A, Meyer A, et al. Experimental evidence from an animal model of adenocarcinoma that chronic inflammation enhances lung cancer risk. Chest 2000;117:228S.
19. Mayne ST, Buenconsejo J, Janerich DT. Previous lung disease and risk of lung cancer among men and women nonsmokers. Am J Epidemiol 1999;149:13–20.
20. McCann J. Esophageal cancers: changing character, increasing incidence. J Natl Cancer Inst 1999;91:497–8.
21. Pirenne J, Pirenne-Noizat F, de Groote D, et al. Cytokines and organ transplantation. A review. Nucl Med Biol 1994;21:545–55.
22. Gaya SB, Rees AJ, Lechler RI, et al. Malignant disease in patients with long-term renal transplants.Transplantation 1995;59:1705–9.
23. Lindelof B, Sigurgeirsson B, Gabel H, et al. Incidence of skin cancer in 5356 patients following organ transplantation. Br J Dermatol 2000;143:513–9.
24. Danesh J, Whincup P, Walker M, et al. Low-grade inflammation and coronary heart disease: prospective study and updated meta-analyses. BMJ 2000;321:199–204.
25. Ferrucci L, Harris TB, Guralnik JM, et al. Serum IL-6 level and the development of disability in older persons. J Am Geriatr Soc 1999;47:639–46.
26. Cesari M, Penninx BW, Pahor M, et al. Inflammatory markers and physical performance in older persons: the InCHIANTI study. J Gerontol A Biol Sci Med Sci 2004;59:242–8.
27. Hutchinson WL, Koenig W, Frohlich M, et al. Immunoradiometric assay of circulating C-reactive protein: age-related values in the adult general population. Clin Chem 2000;46:934–8.
28. Ershler WB. Interleukin-6: a cytokine for gerontologists. J Am Geriatr Soc 1993;41:176–81.
29. Kushner I. C-reactive protein elevation can be caused by conditions other than inflammation and may reflect biologic aging. Cleve Clin J Med 2001;68:535–7.