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CTRI Number  CTRI/2022/10/046778 [Registered on: 26/10/2022] Trial Registered Prospectively
Last Modified On: 22/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   “Developing and Validating a new instrument or scale to measure fatigue among Cancer Patients”. The study procedure includes completing a demographic proforma and self-reported questionnaire by the cancer patients on fatigue at one time.  
Scientific Title of Study   Development and Validation of an Integrated Fatigue Scale. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arpitha Poopady 
Designation  Ph.D Scholar (part time) 
Affiliation  Nitte Usha Institute of Nursing Sciences (Nitte University) 
Address  Medical Surgical Nursing Dept. Nursing division, Oncology OPD. Kotekar Beeri Road, Paneer, Deralakatte, Mangaluru, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9495700466  
Fax  8242203173   
Email  arpitha.20phd101@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sabitha Nayak 
Designation  Vice Principal 
Affiliation  Nitte Usha Institute of Nursing Sciences (Nitte University) 
Address  Dr. Sabitha Nayak Vice Principal Nitte Usha Institute of Nursing Sciences (Nitte University) Kotekar Beeri Road, Paneer, Deralakatte, Mangaluru, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448842698  
Fax  8242203173   
Email  sabitha@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sr Doris Mookanamparambil 
Designation  Professor 
Affiliation  Kerala University of Health Sciences 
Address  Professor Holy Cross College of Nursing Kottiyam, Kollam Dt Pin 691571 Kerala ST.

Kollam
KERALA
691571
India 
Phone  9497358450  
Fax  2530624  
Email  dorislona@yahoo.co.in  
 
Source of Monetary or Material Support  
Sr. vinny Administrator Holy Cross Hospital Kottiyam, Kollam Dt Pin 691571 
 
Primary Sponsor  
Name  Holy Cross Hospital 
Address  Administrator Holy Cross Hospital Kottiyam, Kollam Dt Pin 691571 Kerala St 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sr Doris  Amala Cancer Iinstitute   Amala Cancer Iinstitute Amala Nagar PO, Thrissur PIN 680555, Kerala St.
Thrissur
KERALA 		 9497358450
2530624
dorislona@yahoomail.co.in 
Sr Doris  Holy cross Hospital  Holy cross Hospital Kollam Kottiyam PIN 691571 Kerala st India
Kollam
KERALA 		 9497358450
2530624
dorislona@yahoomail.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Central Ethics Committee Nitte Deemed to be University  Approved 
Holy Cross hospital Ethics Committee  Approved 
Institutional Ethics Committe Amala Institute of Medical Sciences, Thrissur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D099||Carcinoma in situ, unspecified, (2) ICD-10 Condition: D00-D09||In situ neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Cancer patients
1.Who are between 18 to 65 years
2.Who are able to read and write English, Kannada
or Malayalam
3. Who are informed of their cancer diagnosis and
undergoing/undergone treatment
 
 
ExclusionCriteria 
Details  Cancer patients
1.Who are suffering from severe mental or cognitive
disorders
2. Who are referred to palliative care services for
end of life care
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The development of an Integrated Fatigue Scale for cancer patients. This newly developed integrated fatigue scale will be brief and easy to administer and patient friendly. It will measure fatigue based on the self-reported symptoms of cancer patients and will help in treating the cancer patients in time and can enhance their quality of life.   eight weeks time 
 
Secondary Outcome  
Outcome  TimePoints 
Development and Validation of an Integrated Fatigue Scale to measure fatigue in cancer patients.   outcome will be assessed only once at baseline.
Cross sectional study.
 
A newly developed and validated integrated fatigue scale will be available for public for research use.  From 2024 October on wards  
 
Target Sample Size   Total Sample Size="950"
Sample Size from India="950" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  after publication link will be given

  6. For how long will this data be available start date provided 15-10-2023 and end date provided 15-08-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Cancer related Fatigue(CRF) is highly prevalent and distressing symptom  in the majority of patients both during treatment for cancer  and in the period following of the treatment.CRF interferes with the patient’s ability to perform daily activities and limits personal and social roles within the family and community resulting in significant decrement in overall quality of life.
Being a cancer patient, researcher understood how important it is to assess fatigue  in cancer patients and carry out need based nursing interventions to alleviate symptoms. Most of the time fatigue is given  less importance  by nurses, doctors and other health care team members as they  are not aware of CRF in cancer patients.
Hence the importance of having an instrument that can assess fatigue in routine nursing care is necessity to give due importance in the  planning, implementng and evaluating the  process of nursing care to cancer victims. therefore the researcher has taken initiative to undertake this study to develop an integrated fatigue scale.
 
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