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CTRI Number  CTRI/2021/06/034218 [Registered on: 14/06/2021] Trial Registered Prospectively
Last Modified On: 28/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Multicomponent Intervention(Progressive Muscle Relaxation, Guided Imagery and Information Booklet)]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of an Intervention Programme on Symptom Burden in Chemotherapy  
Scientific Title of Study   Effectiveness of a multicomponent intervention on symptom burden during chemotherapy 
Trial Acronym  MCIT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Theertha P Krishna  
Designation  Post Graduate Student  
Affiliation  MIMS College of Nursing  
Address  Medical Surgical Nursing Department MIMS College of Nursing Vadakkedathparamba Puthukode Post Malappuram

Malappuram
KERALA
673633
India 
Phone  9605107208  
Fax  04832832992  
Email  theerthapk99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shejila C H 
Designation  Professor 
Affiliation  MIMS College of Nursing  
Address  MIMS College of Nursing Vadakkedathparamba Puthukode Post Malappuram

Malappuram
KERALA
673633
India 
Phone  8129673026  
Fax  04832832992  
Email  drshejila@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shejila C H 
Designation  Professor 
Affiliation  MIMS College of Nursing  
Address  MIMS College of Nursing Vadakkedathparamba Puthukode Post Malappuram

Malappuram
KERALA
673633
India 
Phone  8129673026  
Fax  04832832992  
Email  drshejila@gmail.com  
 
Source of Monetary or Material Support  
MIMS College of Nursing,Vadakkedathparamba, Puthukode post,Malappuram,kerala  
 
Primary Sponsor  
Name  MIMS College of Nursing  
Address  Vadakkedathparamba Puthukode Post Malappuram Kerala  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Theertha P Krishna  MIMS Hospital  Oncology Department, Malabar Institute of Medical Sciences, Govindapuram post Calicut Kozhikode KERALA
Kozhikode
KERALA 		 9605107208
04832832992
theerthapk99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Malabar Institute of Medical Sciences Ltd   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (2) ICD-10 Condition: C18||Malignant neoplasm of colon, (3) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multicomponent Intervention  Multicomponent Intervention includes Progressive Muscle Relaxation, Guided Imagery and Information Booklet which is given at the beginning of chemotherapy. Daily patients will practice it once in a day for 6 weeks.  
Comparator Agent  Usual care   Routine care Given by Doctors, Nurses and other Health care professionals daily  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Aged 18 years or older.
Diagnosed with stage 1 to stage 3 of Breast and Colorectal cancer
Starting their first treatment with IV chemotherapy requiring outpatient hospital visits
Willing to participate in the study and give voluntary consent.
Able to speak, read and write in Malayalam. 
 
ExclusionCriteria 
Details  Metastatic cases
Undergoing concurrent radiation and hormonal treatment.
Having severe cognitive/emotional issues as determined by the patient’s treating oncologist.
Already received chemotherapy for their malignancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Symptom burden  3 time points
Baseline (day 1 of 1st Cycle)
3rd week of chemotherapy
6th week of chemotherapy 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/06/2021 
Date of Study Completion (India) 29/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="14" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [drshejila@gmail.com].

  6. For how long will this data be available start date provided 02-12-2021 and end date provided 02-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The aim of the study is to assess the effectiveness of a Multicomponent intervention on symptom burden in cancer patients receiving chemotherapy. Based on randomization ,intervention  group will get multicomponent intervention(Progressive muscle relaxation , guided imagery and Information Booklet) and control group will receive usual care. Informed consent will be obtained before data collection .Baseline assessment of symptom burden will be done using Edmonton  Symptom Assessment Scale at day 1 of 1st cycle of chemotherapy and intervention group will get intervention.3rd week and 6th week reassessment of symptom burden will be done. Data will be analyzed by descriptive and inferential statistics. 
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