Rajiv Gandhi University of Health Sciences, Karnataka



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Rajiv Gandhi University of Health Sciences, Karnataka

Curriculum Development Cell










Registration No.

:

Name of the Candidate

: Ms. VIRALI N. MAGIYA

Address

: S.D.M. College of Physiotherapy, Manjushreenagar,

Sattur, Dharwad



Name of the Institution

: S.D.M College of Physiotherapy, Dharwad

Course of Study and Subject

: MPT (Physiotherapy In Neurological and

Psychosomatic disorders)



Date of Admission to Course

: 17/05/2012.

Title of the Topic

:“TO STUDY THE EFFECT OF DYSPHAGIA ON QUALITY OF LIFE IN PATIENTS TREATED FOR HEAD AND NECK CANCER USING M.D.ANDERSON DYSPHAGIA INVENTORY.”

Brief resume of the intended work

: Attached

Signature of the Student

:

Guide Name

Remarks of the guide



: Dr. SHARMILA DUDHANI.

: RECOMMENDED FOR REGISTRATION

Signature of the Guide

:

Co-Guide Name

:

Signature of the Co-Guide

:

HOD Name

: Dr. RAVI SAVADATTI.

Signature of the HOD

:

Principal Name

: Dr. RAVI SAVADATTI.

Principal Mobile No.

: 9845051209

Principal E-mail ID

: sdmcpt@gmail.com

Remarks of the principal

: RECOMMENDED FOR REGISTRATION

Principal Signature

:



A)


BRIEF RESUME OF THE STUDY :
INTRODUCTION:
Dysphagia is derived from Greek word dys meaning bad or disordered and phago meaning “eat”. Dysphagia is defined as a sensation of “sticking” or obstruction of the passage of food through the mouth, pharynx, or esophagus.1 Dysphagia is defined as a condition in which an individual had an interruption in either eating function or the maintenance of nutrition. Any disturbance in swallowing process results in dysphagia. The swallowing process is composed of a number of complex neuromuscular events. Normal swallowing requires an individual to be able to move food or liquid from the mouth, through the pharynx and ultimately into the esophagus.2
Dysphagia is classically divided into two types (1) Oropharyngeal dysphagia, the problem is in mouth and/or throat. Oropharyngeal dysphagia is common in head and neck cancer, post-stroke status and neurological diseases. (2) In esophageal dysphagia, the problem is in esophagus. It is commonly seen in progressive systemic sclerosis, post-operative recovery of the esophagogastric junction including bariatric surgery.3
Oropharyngeal dysphagia is common in head and neck cancer, stroke and other neurological diseases like amyotrophic lateral sclerosis and Parkinson’s disease. Term head and neck cancers refer to a group of cancers found in the head and neck region. This includes tumors found in: oral cavity, paranasal sinuses, nasal cavity, pharynx, and larynx. Cancers that are known collectively as head and neck cancers usually begin in the squamous cells that line the moist, mucosal surfaces inside the head and neck (for example: inside the mouth, the nose, and the throat). These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. Most important risk factors are tobacco, alcohol consumption and human papillomavirus.4 Dysphagia can profoundly affect post treatment recovery as it causes malnutrition, dehydration and increased risk of aspiration, poor wound healing and reduced tolerance to medical treatment.5,6
Head and neck cancer is the sixth most common type of cancer, representing about 6% of all cases and accounting for an estimated 650,000 new cancer cases and 350,000 cancer deaths worldwide every year.4 Head and neck cancers are amongst the commonest malignancies, accounting for approximately 20% of the cancer burden in India. Standardized incidence rate was 0.06 per 100,000 populations.7
Dysphagia is a common symptom of head and neck cancer or sequelae of its management. The severity of the swallowing deficit is dependent on size and location of the lesion, the degree and extent of surgical resection; the nature of reconstruction or the side effects of medical treatments.5,8 Radiation has both early and late side effects that can affect the swallowing function. Early effects include xerostomia, erythema, superficial ulceration, bleeding, pain and mucosities. These effects usually result in oral pain that may cause only minimal diet alteration, require prescription of pain medications or non oral nutrition. Late radiation effect may include osteoradionecrosis, trismus, reduced capillary flow, altered oral flora, dental caries, and altered taste sensation. The late effect of reduced blood supply to the muscle can result in fibrosis, reduced muscle size, and the need for replacement with collagen. This can dramatically affect the swallowing function. Chemotherapeutic agents for head and neck cancer can also cause side effects that impact nutrition and functions of swallowing. They can cause nausea, vomiting, neutropenia, generalized weakness, fatigue, anorexia, weight loss and mucositis; which may cause sufficient pain to require non-oral supplementation. Dysphagia may be caused by surgical ablation of muscular, bony, cartilaginous, or nervous structures.
There are many scales for assessing quality of life (QOL) in patient with dysphagia. M.D.Anderson Dsphagia Inventory (MDADI) is self-administered and validated inventories developed specifically to evaluate the impact of dysphagia on the QOL of patients who are undergo treatment for head and neck cancer. The MDADI is composed of 20 questions divided in four domains: global, physical, functional and emotional. It is scored from 0 to 100, with lower score indicating a greater impact on QOL.9,10
NEED FOR THE STUDY:
Head and neck cancer is the sixth most common type of cancer in world. In India, head and neck cancers are amongst the commonest malignancies, accounting for approximately 20% of the cancer burden.7 Tobacco chewing and consumption of alcoholic beverages have become common social habits in India. These common social habits have been positively associated with oral cancer.11

Dysphagia is a common complaint in patients with head and neck cancer. It leads to nutritional deficiency, weight loss, prolonged unnatural feeding and also has a major potential risk for aspiration. Dysphagia resulting from head and neck cancer has psychological implication. Meal time consumption is significantly altered because of swallowing problem. Patient’s inability to participate in mealtime and dining out may lead to isolating them. Increased meal time, limited food choice, special preparation methods and untidy consumption contribute to avoidance of social food. Family relation is altered because of substantial life style modification. Patients become dependent on the medical provider and family members for basic care and emotional support. After cancer recovery, patients may experience distress related with return to work and the alteration in the feeding process. The financial impact of dysphagia is evident in the cost of non-oral tube feeding supplementation. Special meal preparation, equipment, and meal supplement can also contribute to financial burden. Self-esteem can be affected when normal facial appearance or communication ability altered by surgery. Altered facial appearance also can lead to social isolation and psychological distress. Ultimately dysphagia causes functional and social limitation, nutritional deficiencies, mood disorders and worsen the quality of life. Hence need for the study arises to asses the effect of dysphagia on quality of life.






RESEARCH HYPOTHESIS:

Null hypothesis (H0):


There will be no effect of dysphagia on quality of life in patients treated for head and neck cancer.

Alternate Hypothesis (H1):


There will be effect of dysphagia on quality of life in patients treated for head and neck cancer.
REVIEW OF LITERATURE:
Head and neck cancer is a broad term that encompasses epithelial malignancies that arise in the paranasal sinuses, nasal cavity, oral cavity, pharynx, and larynx. All of these epithelial malignancies are squamous cell carcinoma of the head and neck (SCCHN). Most important risk factors for head and neck cancer are tobacco, alcohol consumption, human papillomavirus (HPV). Head and neck cancer is the sixth most common type of cancer, representing about 6% of all cases and accounting for an estimated 650,000 new cancer cases and 350,000 cancer deaths worldwide every year.4

Head and neck cancers are amongst the commonest malignancies, accounting for approximately 20% of the cancer burden in India. The major risk factors are tobacco chewing, smoking and alcohol consumption. The crude rate and age standardized incidence rate was 0.05 and 0.06 per 100,000 population respectively. The most common age group for all malignant biopsies was 7th decade for males and the 5th decade for females.7


Dysphagia, derived from the Greek phagein, meaning "to eat," is a common symptom of head and neck cancer and can be unfortunate sequelae of its treatment. Dysphagia may be caused by surgical ablation of muscular, bony, cartilaginous, or nervous structures or may be attributable to the effects of antineoplastic agents including radiation and/or chemotherapy. Dysphagia is any disruption in the swallowing process during bolus transport from the oral cavity to the stomach. The severity of the swallowing deficit is dependent on the size and location of the lesion, the degree and extent of surgical resection, the nature of reconstruction, or the side effects of medical treatments. It may also causes aspiration pneumonia, dehydration, malnutrition, poor wound healing, and reduced tolerance to medical treatments.5
Patients with cancerous tumors of the oral cavity, pharynx or larynx will usually be treated for their disease with surgical removal of the tumor, radiotherapy, chemotherapy or a combination of these procedures. Each type of cancer treatment may result in some degree of dysphagia. The type and severity of dysphagia will depend upon the size and location of the original tumor, the structures involved, and the treatment modality used for cure.8
Head and neck cancer patient having oropharyngeal dysphagia, which refers to difficulty in swallowing from mouth to the esophagus. Its severity may vary from moderate difficulty swallowing to impossibility of oral feeding. Its etiology is multifactorial due to the consequences of surgery and coadjutant treatment. It causes severe complication such as malnutrition, dehydration and also increased risk of aspiration. It also affect patient nutritional status and quality of life.6
Dysphagia resulting from head and neck cancer has psychological implication. Meal time consumption is significantly altered because of swallowing problem. Patient’s inability to participate in mealtime and dining out may lead to isolating them. Patients become dependent on the medical provider and family members for basic care and emotional support. After cancer recovery, patients may experience distress related with return to work and the alteration in the feeding process. The financial impact of dysphagia is evident in the cost of non-oral tube feeding supplementation. Special meal preparation, equipment, and meal supplement can also contribute to financial burden. Self-esteem can be affected when normal facial appearance or communication ability altered by surgery. Altered facial appearance also can lead to social isolation and psychological distress. Ultimately dysphagia affects functional, physical, emotional aspect of patient.5
A cross sectional study was done to asses Validation and Application of the M.D. Anderson Dysphagia Inventory in Patients Treated for Head and Neck Cancer in Brazil, 2012. 72 adult patients were included for study with mean age of 63 year who was treated for head and neck cancer. Validity and reliability of MDADI were performed through the comparison of the MDADI with three other health-related QOL questionnaires administered at the time of enrollment and 2 weeks after its application. Test–retest reliability for the total score in the MDADI had an ICC greater than 0.795 (p < 0.001). MDADI is a self-administered and validated inventory develop specifically to evaluate the impact of dysphagia on QOL in english speaking patients who undergone treatment for head and neck cancer.8
A prospective, double blinded, randomized case control study was conducted to evaluate the effect of neuromuscular electrical stimulation (NMES) in patients suffering from dysphagia following treatment for head and neck cancer between January 2006 and December 2007, 14 patients were randomized to 30 min of NMES and 30 min of traditional swallowing training for 5 days per week for 2 weeks (experimental group) and 12 patients were randomized to sham stimulation plus traditional swallowing training (control group). Effects were assessed using the clinical dysphagia scale (CDS), the functional dysphagia scale (FDS), the American speech-language-hearing association national outcome measurement system (ASHA NOMS) and the M.D. Anderson Dysphagia Inventory (MADI). Pretreatment evaluation showed no significant differences between the two groups for all parameters. CDS, ASHA NOMS and MADI showed some difference with treatment, but the changes were not significant (P > 0.05). Study concluded that NMES combined with traditional swallowing training is superior to traditional swallowing training alone in patients suffering from dysphagia following treatment for head and neck cancer.12





OBJECTIVES OF THE STUDY:

  1. To find out the effect of dysphagia on quality of life in patients treated for head and neck cancer.





B)


PROCEDURE, MATERIALS AND METHODS:




SOURCE OF DATA COLLECTION:
Shri Dharmasthala Manjunatheshwara College of Dental Science and Hospital, Dharwad.





METHOD OF COLLECTION OF DATA:
The present study is a cross-sectional study. All the patient who are treated for head and neck cancer, Coming to dental and craniofacial outpatient/ inpatient department will be included in this study. After finding their suitability as per their inclusion and exclusion criteria, subjects who are willing to participate will be included. A written informed consent will be taken from the patients.
MATERIAL :


  1. M.D.Anderson Dysphagia Inventory (MDADI) scale.


INCLUSION CRITERIA:


  1. Patients undergoing treatment for head and neck cancer with dysphagia.

  2. Age - above 18 years.

  3. The patients with a sufficient knowledge of the Kannada or English language and the physical and mental ability to understand and answer the questions.


EXCLUSION CRITERIA:


  1. Patient having dysphagia due to any other cancer or condition.

  2. Patient having any mental health issue which prevents the patient to understand the questionnaire.


Study Design: cross sectional study.
Study duration: 1 year.
Sample size:

  1. According to study prevalence of dysphagia in head and neck cancer patients is 50.6%

in Spain. Sample size is calculated by using % error = 4pq / L2 formula.

P = Prevalence.

q = (100 – p)

L = Estimated error.


20 % error = 4 × 50.6 × 49.4 / 102.4144

20 % error= 97

Sample size is 97.
PROCEDURE:
Patients who have met the inclusion criteria will be included in the study. Patients willing to participate will be briefly explained about the study and a written consent will be taken. The demographic data and mode of treatment details of the patients will be collected by therapist. M.D. Anderson Dysphagia Inventory (MDADI) will be given to the patient and any query regarding understanding the questions will be cleared at the same time by the therapist. The MDADI is composed of 20 questions which are divided in four domains i.e. global, physical, functional and emotional. Five possible responses (strongly agree, agree, no opinion, disagree, and strongly disagree) to each items on the MDADI were printed and scored on a scale of 1 to 5. One item on the emotional subscale (I do not feel self-conscious when I eat) and another on the functional subscale (I feel free to go out to eat with my friends, neighbors, and relatives) were scored as 5 points for strongly agree and 1 point for strongly disagree. All other items were scored as 1 point for strongly agree and 5 points for strongly disagree. The first question (global subscale) was scored individually. All other questions regarding each aspect (emotional, functional, and physical) of dysphagia were summed, and a mean score was then calculated. This mean score was multiplied by 20 to obtain a score, with a range of 0 (extremely low functioning) to 100 (high functioning). Thus, a higher MDADI score represented better day-to-day functioning and better QOL. The filled MDADI questionnaires will be collected by therapist. The scores of patients on MDADI will be sent for statistical analysis.


OUTCOME MERSURE:

M.D.Anderson Dysphagia Inventory (MDADI) scale.


Statistical Tests to be Used:

  1. Paired t-test.


DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

IF SO DESCRIBE BRIEFLY – YES.

Administration of M.D.Anderson Dysphagia Inventory scale.


HAS ETHICAL CLEARANCE BEEN OBTAINED BY YOU – Yes.
LIST OF REFERENCES:
1) Braddom RL. Buschbacher RM. Dumitru D. Johnson EW. Matthews D. Sinaki M. Physical Medicine Rehabilitation. Philadelphia: W.B.Squnders Company; 1996.p.533-554. (Rehabilitation of patients with swallowing disorders).

2) O’Sullivan SB. Schmitz TJ. Physical Rehabilitation. 5th ed. Philadelphia: Jitendra P. vij; 1915.p.1203-1204.( Neurogenic disorders of speech and language).

3) Ssallum RA. Duarte AF. Cecconello I. Analytic review of dysphagia scales. Revisãoanalítica das escalas de disfagia 2012 Jun17;25(4):279-282.

4) Argiris A. Karamouzis M. Raben D. Ferris R. Head and neck cancer. The Lancet 2008 May 17-13;371(9625):1695–1709.

5) Gaziano J. Evaluation and Management of Oropharyngeal Dysphagia in Head and Cancer. Medscape 2002 Jun 11; 9(5):400-409.

6) Garcia P. Paron L. Velasco C. de la Cuerda C. Camblor M. Breton I et al. Long term prevalence of oropharyngeal dysphagia in head and neck cancer patients: Impact on quality of life. Science direct 2007 Aug 30;26:710-717.

7) Siddiqui MS. Chandra R. Aziz A. Suman S. Epidemiology and histopathological spectrum of head and neck cancers in Bihar a state of Eastern India. Asian pacific journal of cancer prevention 2012;13(8):3949-53.

8) Pauloski B. Rehabilitation of dysphagia following head and neck cancer. Phys Med Rehabil Clin N Am 2008 Nov 10;19(4):889-928.



9) Guedes R. Angelis E. Chen A. Kowalski L. Vartanian J. Validation and Application of the M.D. Anderson Dysphagia Inventory in Patients Treated for Head and Neck Cancer in Brazil 2012 Jun 9;28:24-32.

10) Chen A. Frankowski R. Leone J. Hebert T. Leyk S. Lewin J et al. The Development and Validation of a Dysphagia-Specific Quality-of-Life Questionnaire for Patients With Head and Neck Cancer, The M. D. Anderson Dysphagia Inventory. Arch Otolaryngol Head Neck Surg 2001 Jul;127:870-876

11) Saraswathi TR. Ranganathan K. Shanmugam S. Sowmya R. Narasimhan P. Gunaseelan R. Prevalence of oral lesions in relation to habits: Cross-sectional study in South India. Oral Epidemiology 2006;17(3):121-125.

12) Ryu J. Kang J. Park J. Nam S. Choi S. Roh J et al. The effect of electrical stimulation therapy on dysphagia following treatment for head and neck cancer. Oral oncology 2009 Dec 17;45:665-668.














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