Title: To study the awareness and attitudes towards end of life care in primary caregivers of patients with advanced cancer: questionnaire based cross sectional study.

Introduction:

            The concept of end of life care stems from the idea that death should be peaceful and not prolonged by life support which is considered futile in such circumstances. WHO recognizes palliative care as a global public health issue and it should be implemented in all strata of society. The main concept of palliative care is to provide comfort and supportive care to improve quality of life in patients with advanced diseases. Palliative care is an approach that improves the quality of life of patients and families facing terminally ill and fatal diseases. Despite all this, awareness about palliative and terminal care remains at ignorance level and attitudes of relatives of advanced cancer patients are not supportive.

            End of life care (EOLC) is defined as comfort care for those who are terminally ill so that they can have a peaceful death surrounded by family and friends.^[1] It is an extension of the continuum of palliative care which goes a step further to provide pain relief and compassionate care. The term palliative care comes from the latin word “palliare” which means “to cloak”.^[2] The concept of end of life care has five prime dimensions- medical, psychological, social, ethical and legal. It is not restricted only to hospitals and intensive care units but should begin at community life as well.  

                        When to initiate EOLC discussion with family members is a grey-shaded that needs further investigation. Physician surveys have illustrated that most of them are not sure when and how to break bad news and initiate EOLC.^[6] EOLC can be incorporated in terminally ill cancer patients, chronic pulmonary disorders, cardiac failure and progressive neurological diseases and brain dead patients.

            In this study we have tried to find out the general awareness of EOLC among primary caregivers of patient with advanced cancers receiving palliative care. This would help to collect data and concerns for future planning of EOLC awareness programmes for better acceptability of the EOLC among community and thus better quality of life with judicious use of available resources in best interests of the society.

Aim: 

            To assess the awareness and attitudes regarding end-of life care among the primary care-givers of patients with advanced cancer receiving palliative care at a tertiary care cancer centre.

Materials and Methods:

            This cross-sectional study will be done among primary care givers of patients with advanced cancer receiving palliative care at DR BRAIRCH, AIIMS, New Delhi after approval from Institute Ethics committee. The primary caregiver will be identified by enquiring the attendants or the patient. The primary care giver will be explained about the study protocol and written informed consent will be taken. All patients receiving palliative chemotherapy and radiation will be included in the study.

Inclusion criteria:

1.      Primary care givers of patients suffering from advanced cancer who have been denied curative treatment including chemotherapy, radiotherapy and surgery.

Exclusion criteria:

Primary care givers of patients who refuse to give consent for the study

Assessment:

            A standardized questionnaire based interview will be organized in a comfortable and convenient place for the primary care giver.  All the questions will be explained to the relative in a clear and lucid manner in the language they can comprehend (English or Hindi). The palliative care physician will be involved in the interview of each caregiver and in the case of more than one caregiver, separate interviews will be organized and recorded separately.

Designing of study tool: Questionnaire for assessing awareness and attitudes of primary caregivers towards end of life care in advanced cancer patients:

            Instrument was designed via a 3 step process of determining content domain, sampling from content (item generation) and instrument construction. The content of questionnaire was collected based on literature review with regards to various parameters for assessment of awareness and attitudes related to end of life issues. Also, opinion from subjects experts were obtained for the potential contents to be assessed for the purpose of assessing awareness of end of life issues in care givers. Based on these sources, a set of questions were generated and translated in Hindi language as well. The questionnaire so generated was provided to palliative care professionals (5 subject experts) to assess for any ambiguity, missing contents, relevancy or representativeness, clarity and comprehensiveness of the items of the questionnaire. They will evaluate for face and content validation of the questionnaire. The feedback was analyzed and revision was made in the questionnaire. The final questionnaire was developed through a consensus method after taking inputs from the experts. This questionnaire was provided to 10 lay persons (5 lay persons and 5 care givers of advanced cancer patients) to comment on the understanding of the different items of the questionnaire. There feedbacks were analyzed and questionnaire was modified accordingly. Finally, operational instrument was constructed after final generated items were refined and organized in the proper format and sequence as appended with this protocol.

            The questionnaire comprises of various sections:

·         Part A will comprises about the details of the patient as per hospital record and will be recorded from the hospital record file of the patient;

·         Part B will contain demographic details of the primary care giver and

·         Part C will contain the questionnaire and its following subparts which will be completed by the primary caregiver assisted by the researcher.

Research tool: The questionnaire will involve the following:

a.       The caregivers will be assessed regarding the knowledge about the primary disease and the necessary outcome. The basic knowledge about the time of diagnosis of the primary cancer. The course of the disease including progression into advanced stage. The number of cycles of chemotherapy and radiation doses received. Specific data will be elicited regarding the date of surgery, last cycle of chemotherapy or radiation received and the extent of spread of the disease. The final consensus will be asked about the present stage of the disease and extent of metastasis. Whether the patient is amenable to further palliative therapy or is refractory to further treatment. By definition, patients who were not receiving definitive chemotherapy or radiation were suffering from advanced cancer.  Whether the patient has already been started on palliative treatment and his desire to decline further definitive therapy will be recorded.

b.      A baseline knowledge regarding palliative care among the caregivers will be recorded. Their source of information (friend, relative, television, media or magazine) including those caregivers that work in a medical setup or palliative care units. The consensus among the treating doctors and further course of treatment will be dwelled upon.

c.       A close loop communication regarding the end of life care issues and its components will be assessed in the caregivers. The futility of continuing aggressive treatment and its probable consequences will be and the response of the caregivers recorded. Interventions prolonging life support (mechanical ventilation, invasive lines, vasopressors and dialysis) will be discussed with caregivers. Nature of comfort care and level of care will be asked including their will to give home based or institution based hospice care.

d.      Financial issues and support will be discussed and their impact in initiating palliative care or foregoing life supporting treatment (FLST) will be discussed. Satisfaction about the level of care received will be recorded in a subjective assessment scale (very satisfied, satisfied and not satisfied).

Primary Objective:

1.      To assess the awareness and attitude of primary caregivers towards end of life care in advanced cancer patients.

Secondary Objective:

1.      To correlate various parameters with awareness of end of life care in primary care givers of advanced cancer patients.

Statistical analysis:

            This would be a pilot study as no data is available with regards to awareness of end of life issues in care givers of advanced cancer patients requiring palliative care. So a formal sample size calculation is not feasible. At this centre, we receive around 3-4 new such patients every week. So we would assess 100 primary care givers over an approximate duration of one year. In view of the objectives of the study, to assess the scales of measurement of outcome and covariates appropriate statistical analytical methods will be used.