ABSTRACT

Head and neck cancer, being the most common in India, has a high prevalence rate with a much higher demand for care and support. This can be very challenging in its own ways. It starts taking a toll on the mental, social and economic aspect in the lives of the patients’ loved ones, leaving them stressed and eventually affecting their overall physical health.

The proposed study is a prospective cohort study that will be conducted on 28 participants aged 21 years or more, who stays with the patient throughout the entire treatment modality, providing necessary care and support. Whole salivary samples of the caregiver will be collected on Day 1, Day 21 and Day 42 of the radiotherapy session while simultaneously handing out the Caregiver Quality of Life Index- Cancer Scale (CQOLC) for them to administer. Saliva sample collection and the samples will be collected an hour prior to the initiation of the radiotherapy session for the respective patient. The samples will be later analysed using the ELISA kit to measure the cortisol levels.

OBJECTIVES

·          To assess the caregiver burden and quality of life using the Caregiver Reaction Assessment (CRA) and Caregiver Quality of Life Index-Cancer Scale (CQOLC)

·        To assess the caregiver burden and quality of life by estimating the salivary cortisol levels at different intervals of the radiotherapy session.

·        To compare the cortisol levels in the caregiver providing support to the head and neck cancer patients.

·        To compare the cortisol levels of the caregiver with the outcomes of the CRA and the CQOLC scale.

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      NEED FOR THE STUDY:

The present study will help in finding the stress level among the caregivers of patients undergoing radiation therapy for head and neck cancer. To the best of our knowledge, there were no previous studies regarding the assessment of the biopsychosocial impact on caregivers of head and neck cancer patients undergoing radiotherapy available in Indian population. The result of this study can be utilised to establish guidelines for effective management of stress among the caregivers and thereby provide better care for the patients. It will in fact provide assistance to the healthcare professionals for extending support to the caretakers accordingly. Improvement in caregivers’ quality of life may have a direct impact on the psychosocial aspect of the patients’ life and indirectly in the improvement of quality of life of patients.

STUDY DESIGN

     Prospective Cohort Study

MATERIALS AND METHODS

 Materials:

Disposable gloves, N95 and surgical mouthmasks, sterile test-tubes, ELISA kit.

 Procedure:

The proposed study will be a prospective Cohort study with following procedural steps.

·         Obtaining approval for the study protocol from Scientific Review Board, Yenepoya deemed to be University, Mangaluru.

·         Obtaining approval for the study protocol from Institutional Ethics Committee, Yenepoya deemed to be University, Mangaluru.

·          Obtaining the official permission to conduct the study from Department of Oncology, Yenepoya Medical College and Hospital, Mangaluru.

·         Obtaining the informed consent from the study participants (Annexure II)

·         The study sample will comprise of 28 participants (caregivers to the patients) aged 21 years and above who will be included based on the inclusion and exclusion criteria, in the Department of Oncology for the treatment of head and neck cancer.

·         Principal investigator will assess the caregivers of the patients based on the inclusion criteria and carry out the sample collection and questionnaire fill up.

·         The questionnaire has been adapted from the study conducted by Weitzner M A et al (1999).

 Methodology:

The proposed study will be conducted amongst 28 participants of age 21 years and more, who is a spouse, family member, close relative or friend providing care and support to the patient diagnosed with head and neck cancer and  is subjected for radiotherapy as treatment modality in the Department of Oncology, Yenepoya deemed to be University, Mangaluru.

·         Principal investigator will assess the eligible participants for the study based on the inclusion and exclusion criteria by obtaining detailed demographic and medical history. (Annexure III)

·         Whole salivary samples of the selected participants will be collected on Day 1, Day 21 and on Day 42 of the radiotherapy session while simultaneously a pretested validated questionnaire with 35 sets of questions with score 0 to 4 will also be given to be filled up by the participants. (Annexure IV)

·         The questionnaire will be translated to Kannada and Malayalam language and given accordingly to the participants.

·         The participants will be given written instructions beforehand regarding the saliva collection and will be instructed not to eat or drink atleast an hour prior to the sampling. (Annexure I)

·         Unstimulated saliva of the participant (caregiver) will be collected, 1 hour prior to the initiation of the radiotherapy session of their caregiving member (cancer patient), in a sterile test tube under a sterile environment by asking them to spit till sufficient quantity of saliva is achieved (5ml) on day 1, day 21 and day 42 of radiotherapy.

·         The collected sample is then labelled, coded to avoid any bias and to keep it anonymous (except for the principal investigator) and then immediately sent for analysis of salivary cortisol level using ELISA KIT (SALIMETRICS) which is a gold standard for analysis.

·         The samples that are collected will be stored at -20’C at the Yenepoya Research Centre laboratory within half an hour after collection.

·         The analysis will be done according to manufacturer’s instruction.

·         The “Enzyme-Linked Immuno Sorbent Assay” (ELISA) is a commonly used analytical biochemistry assay. The assay uses a solid-phase ‘Enzyme Immuno Assay’ (EIA) to detect the presence of a ligand (commonly a protein) in a liquid sample using antibodies directed against the protein to be measured.⁷ Assays of hormonal steroids are well validated. This method which allows an unstressful sampling versus venipuncture is of great interest, particularly for cortisol. Saliva assays present a lot of advantages when compared to blood assays: the sampling is easy to conduct especially in a non medical environment, and the risk of contamination for the laboratory technician is lower than for blood.

·         The sample collection will be done by the Principal Investigator in Department of Oncology, Yenepoya Medical College and Hospital, Mangalore only after obtaining consent of the selected participants and by following proper safety protocols.

Inclusion criteria:

·         An individual who is a spouse, family member, close relative or friend to the patient diagnosed with head and neck cancer and undergoing radiotherapy, providing care and support throughout the entire duration of the radiotherapy session.

·         Individuals with age of at least 21 years.

·         Individuals who have not been diagnosed with any systemic diseases and are not under any medication. (Annexure III)

Exclusion criteria:

·         Individuals with mental and physical disability.

·         Individuals who are not willing to provide Informed consent.

·         Individuals with anxiety disorder and are under anti-anxiety medication.

·         Alcoholics and smokers.

 Source of data/ sampling method:

          Study setting-

·         The study will be conducted in the Department of Oncology, Yenepoya Medical College and Hospital, Mangalore.

·         The study sample comprises of 28 samples with an age of at least 21 years.

        Sampling method-

 Simple Random sampling

       Sample Size (including sample size calculation)-

In order to estimate 77% of subject to be defined to be psychologically distressed with 5% margin of error, 99% confidence, 28 subjects must be included in the study. This sample size is computed based on the assumption that population of caregivers to the head and neck cancer patients undergoing radiotherapy in the Department of Oncology is limitedly finite.

Statistical Analysis:

·        Data analysis will be done using SPSS 24.0 (Statistical Package of Social Sciences)

      For continuous variable: will be presented by Mean and Standard deviation.

·        For categorical variable: will be presented by frequency and percentage.

·        One way ANOVA statistical test will be used to compare the mean of continuous variable.

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 WORK PLAN (including timeline)

The study will be conducted over a time period from April 2021 to October 2021.