Abstract:

Background: With the increase in the rate of cancer morbidity, there was a marked increase in the research area for the development of strategies for the management of cancer disease. However, this objective could only be achieved through various phase of clinical trials requiring humans as a subject of study. This raised an ethical issue as survey research conducted in the form of questionnaires consisted of the classic questions of anxiety, depression, psychosis, or agitation which may or may not suit the patient’s ability to consent due to certain factors. In the present study, it was observed that how the patient and the care-giver supported in the completion of this research survey during the patient’s inpatient chemotherapy or outpatient radiotherapy treatment.

Objectives: The primary objective of the present study was to determine and analyze the percentage of cancer patients enrolled in the study that required assistance either from the interviewer or from the care-givers in filling up of the QOL questionnaire form during the inpatient chemotherapy or outpatient radiotherapy sessions.

Methods: It was a cross-sectional, descriptive, hospital based evaluation study. Total duration of the study was 5 months (December 2015- April 2016), conducted in Medical and Radiation Oncology department of DR. B.L. Kapur Memorial Hospital, New Delhi, India. A convenience sample of 60 patients with cancer was selected. They were further divided into Chemotherapy group (n= 30) and Radiotherapy group (n= 30). Therefore, 30 cancer patients were on chemotherapy and the other 30 cancer patients were on radiotherapy. Data was obtained through direct interview, using validated Psychological intervention tool in the form of Questionnaire: WHOQOL-Bref Questionnaire, Zung Self-Rating Anxiety scale and Zung Self-Rating Depression scale.

Results: A total of 60 cancer patients were included in the study in which Chemotherapy group consisted of 30n cancer patients and Radiotherapy group consisted of 30n cancer patients. In the study, 6(20%) were males and 24(80%) were females in the chemotherapy group, and, 15(50%) were males and 15(50%) were females in the radiotherapy group. Majority of the patients 32(53.34%) were in the age range of 46-60 years. It was observed that maximum patients in chemotherapy, as well as, radiotherapy groups marked their ability to consent to participate in the study with less assistance from the researcher and the care-givers even during the treatment regimen.

Conclusion: It could be concluded from the results obtained from the study that the patients undergoing chemotherapy (66.6%), or radiotherapy (76.7%) sessions were able to consent freely without much assistance of the researcher or the care-giver. This further implied that in Indian scenario people are becoming more aware and thus, cooperated by participating in research studies so as to help manage the deadly disease “CANCER”.

Keywords: Cancer, Patient’s consent, Patient themselves, Assisted by researcher, Assisted by relatives.

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