| CTRI Number |
CTRI/2018/01/011189 [Registered on: 08/01/2018] Trial Registered Prospectively |
| Last Modified On: |
30/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Tiredness and its causes in patients with cancers which has spreaded |
|
Scientific Title of Study
|
To assess the Prevalence and Predictors of Fatigue and its Impact on Quality of Life in advanced cancer patients receiving palliative care in a tertiary care hospital: A cross-sectional Descriptive study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Garg |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS); New Delhi |
| Address |
Department of Onco-Anaesthesiology and Palliative Medicine,
Room No 139, First Floor, DR BRAIRCH, AIIMS, Ansari Nager, NEW DELHI
South
DELHI
110029
India |
| Phone |
9810394950 |
| Fax |
|
| Email |
drrgarg@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Garg |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS); New Delhi |
| Address |
Department of Onco-Anaesthesiology and Palliative Medicine,
Room No 139, First Floor, DR BRAIRCH, AIIMS, Ansari Nager, NEW DELHI
South
DELHI
110029
India |
| Phone |
9810394950 |
| Fax |
|
| Email |
drrgarg@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Garg |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS); New Delhi |
| Address |
Department of Onco-Anaesthesiology and Palliative Medicine,
Room No 139, First Floor, DR BRAIRCH, AIIMS, Ansari Nager, NEW DELHI
South
DELHI
110029
India |
| Phone |
9810394950 |
| Fax |
|
| Email |
drrgarg@hotmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AlIMS |
| Address |
Departmentof Onco-Anaesthesiology, Room no 135, Dr BRAIRCH, AIIMS, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Garg |
Dr BRAIRCH, All India Institute of Medical Sciences |
Room No 139, First Floor, DR BRAIRCH, AIIMS, Ansari Nager, NEW DELHI
South
DELHI |
9810394950
drrgarg@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethical Commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult (age 18 yrs ) patients with advanced cancer receiving palliative treatment., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult (age > 18 yrs ) patients with advanced cancer receiving palliative treatment and has been denied any curative treatment (medical, surgical or radio therapy) with ECOG score ranging from 0 to 3, predicted survival of > 4 weeks presenting to the palliative care OPD or admitted in the palliative care ward will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients having history of any psychiatric disorder or inability to communicate and ECOG score of 4 and above |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the prevalence of fatigue in advanced cancer patients receiving palliative care. |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the predictive factors of fatigue in advanced cancer patients receiving palliative care.
To find out its impact on quality of life of patients and relation between the fatigue and quality of life receiving palliative care. |
one time |
|
Target Sample Size
Modification(s)
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/02/2018 |
| Date of Study Completion (India) |
01/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Submitted for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Cancer-related
fatigue (CRF) is one of the adverse outcomes of cancer and its treatment.
Despite its high prevalence; the data is scarce from Indian population on
prevalence of CRF and its predictors in advanced cancer patients. So we aim to
find the prevalence of the fatigue, its impact of fatigue on quality of life (QOL)
and possible predictors.
Methods: This study was conducted after approval of the ethical
committee in adult patients of advanced cancer receiving palliative care. The
data collected included demographic details, nutritional status, any
co-morbidities involving cardio-respiratory, renal, pulmonary, neurological
system, type and stage of cancer, site of metastasis, any previous or ongoing
chemotherapy or radiotherapy, history of drug intake, hemoglobin (Hb) and
albumin. The study parameters included assessment of fatigue, QOL and symptom
assessment as per validated tools. The primary objective of the study was to
find out the prevalence of fatigue in advanced cancer patients receiving
palliative care. The secondary objectives were to find out predictive factors
of fatigue, its impact on QOL of patients and relation between the fatigue and
QOL receiving palliative care. The
correlation between fatigue score and QOL was analysed using Pearson’s
correlation coefficient. Multiple linear regression analysis was performed for
identifying the predictors of CRF.
Results: The prevalence of fatigue was 100 % of which severe fatigue
was seen in 97 patients (FACIT-F < 30). The median (IQR) FACIT-F score was
14(8-23). The median (IQR) of overall QOL was 16.66 (16.6- 50).The correlation
between Fatigue (FACIT-F) and QOL was +0.64 (p < 0.001). The predictors of
fatigue included pain, physical functioning, ECOG, tiredness and level of
albumin.
Conclusion: We conclude, the prevalence of fatigue in Indian patients with advanced
cancer receiving palliative care was high and it has a negative impact on QOL.
Pain, physical functioning, performance status, and albumin were found to be
independent predictors of CRF.
|