Determining the factors which affect fatigue and their impact on the quality of life in patients with advanced cancer receiving palliative care

Completed

• Conditions: Advanced cancer patients who are more than 18 years of age and literate having fatigue

• Registration Number: CTRI/2014/04/004565
• Lead Sponsor: Tata Memorial Centre

Brief Summary

**PROTOCOL**

**Determiningthe correlates of fatigue and its impact on the quality of life in palliativecare patients**

**Backgroundand rationale**

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

**Aims:**

To determine thecorrelation of factors associated with fatigue in advanced cancer patient andits impact on their quality of life.

**Hypothesis**

Multiple symptomsrelated to advanced cancer and biological parameters influence fatigue which inturn negatively affects patients’ quality of life

**Methodology**

Prospective,Observational Study in Outpatient department of palliative medicine for a periodof 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 noprior information regarding the factors affecting fatigue to calculate thesample size in our population is available.

Inclusion Criteria:

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

Exclusion Criteria:

ECOG 4, Expectedsurvival <4 weeks

Method:

Patients fitting theeligibility criteria and those who consent for the study will be enrolled forthe study.  The patients will meet thepalliative care team on the day of the referral from oncology OPD and once againbetween 15-30 days. The study protocol will follow standard palliative careplan. The first visit with the palliative care team will comprise of record ofbasic information, educational status, contact number, marital status, cancerdiagnosis, stage, sites of metastasis and treatment, co-morbidities (if any),ECOG score, body weight, recent Hemoglobin and albumin levels, daily oralmorphine consumption[in mg](if any)) from the case record forms in thedepartment, symptom burden assessment using Edmonton Symptom AssessmentSystem  (ESAS) numerical scale andquality of life assessment using the EORTC-QOL PAL15. During the second visitbetween 15-30 days, the following informations will be recorded:  basic information, symptom burden assessmentusing Edmonton Symptom Assessment System (ESAS) numerical scale and functionalassessment using the EORTCQOL PAL15. In case the patient does not turn up forfollow up, then the same data will be captured by telephonic interview andrecorded. Adequate referrals to other care providers will be given as and whenneeded.

All analysis will bedone using PASW Statistics 18

**Risk**

None anticipated. Ifthe subject feels discomfort in answering the questionnaires, then counselorsare available in the department to address these issues.

**Benefits**

1. Determination ofthe factors associated with the severity of Cancer Related Fatigue in advancedcancer patients.

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

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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 15-30days Age more than 18 years and literate Written informed consent given.

Exclusion Criteria

ECOG 4 Expected survival <4 weeks.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To collect data regarding socio demographic details, treatment history, burden of disease(stage), ECOG score, Hemoglobin and albumin, daily oral morphine consumption[mg] at initial visit and first follow-up visit.	On the day of the referral from oncology OPD and once again between 15-30days.
To determine the baseline symptom burden using Edmonton symptom assessment scale at initial visit and change at first follow-up visit.	On the day of the referral from oncology OPD and once again between 15-30days.
To determine the baseline fatigue burden using ESAS fatigue score at initial visit and change at first follow-up visit.	On the day of the referral from oncology OPD and once again between 15-30days.

Secondary Outcome Measures

Name	Time	Method
To determine quality of life using the EORTC- QLQ PAL15 at initial visit and change at first follow-up visit.	On the day of the referral from oncology OPD and once again between 15-30days.

Trial Locations

Locations (1)

Department of Palliative Medicine, Main Building, Ground floor, Room 115, Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Department of Palliative Medicine, Main Building, Ground floor, Room 115, Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr MA Muckaden

Principal investigator

02224177148

muckadenma@tmc.gov.in