PROTOCOL

Determining the correlates of fatigue and its impact on the quality of life in palliative care patients

Background and rationale

Fatigue is one of the most distressing symptoms experienced by patients with advanced cancer. It has a prevalence of 48 to 78% in palliative care settings. It usually coexists with a number of other symptoms that may include pain, anorexia, nausea, vomiting, dyspnea, difficulty sleeping, anxiety, or depression. The relative importance of these predictors is not known in our population.

Aims:

To determine the correlation of factors associated with fatigue in advanced cancer patient and its impact on their quality of life.

Hypothesis

Multiple symptoms related to advanced cancer and biological parameters influence fatigue which in turn negatively affects patients’ quality of life

Methodology

Prospective, Observational Study in Outpatient department of palliative medicine for a period of 6 months after obtaining IRB approval. The study will be conducted at 5% significance level. No formal sample size and power estimation is done as no prior information regarding the factors affecting fatigue to calculate the sample size in our population is available.

Inclusion Criteria:

Advanced cancer patients, ECOG 0,1,2 and 3, ESAS Fatigue score>0, Patient who can adhere to follow-up schedule at Tata Memorial Hospital or available for phone follow-up interview between 15-30 days, Age more than 18 years and literate, Written informed consent given

Exclusion Criteria:

ECOG 4, Expected survival <4 weeks

Method:

Patients fitting the eligibility criteria and those who consent for the study will be enrolled for the study.  The patients will meet the palliative care team on the day of the referral from oncology OPD and once again between 15-30 days. The study protocol will follow standard palliative care plan. The first visit with the palliative care team will comprise of record of basic information, educational status, contact number, marital status, cancer diagnosis, stage, sites of metastasis and treatment, co-morbidities (if any), ECOG score, body weight, recent Hemoglobin and albumin levels, daily oral morphine consumption[in mg](if any)) from the case record forms in the department, symptom burden assessment using Edmonton Symptom Assessment System  (ESAS) numerical scale and quality of life assessment using the EORTC-QOL PAL15. During the second visit between 15-30 days, the following informations will be recorded:  basic information, symptom burden assessment using Edmonton Symptom Assessment System (ESAS) numerical scale and functional assessment using the EORTCQOL PAL15. In case the patient does not turn up for follow up, then the same data will be captured by telephonic interview and recorded. Adequate referrals to other care providers will be given as and when needed.

All analysis will be done using PASW Statistics 18

Risk

None anticipated. If the subject feels discomfort in answering the questionnaires, then counselors are available in the department to address these issues.

 Benefits

1. Determination of the factors associated with the severity of Cancer Related Fatigue in advanced cancer patients.

2. Determination of whether the severity of fatigue has any impact on the Quality of Life domain.

3. Identification of predictors of improvement in fatigue at first follow-up visit