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CTRI Number  CTRI/2025/05/087252 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Complimentary Psychosocial Support]  
Study Design  Other 
Public Title of Study   An exploratory study to assess the effectiveness of Virtual Reality assisted Guided Imagery on quality of life of cancer patients undergoing Chemo-radiation treatment. 
Scientific Title of Study   An exploratory study to assess the effectiveness of Virtual Reality assisted Guided Imagery on quality of life of cancer patients undergoing Chemo-radiation treatment. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sampath Kumar 
Designation  IAS, MPA 
Affiliation  Department of Health & Family Welfare, Government of Meghalaya, State Cancer Society of Meghalaya 
Address  Room No 201, Additional Building, Myntdu Building, IGP Point, Shillong

East Khasi Hills
MEGHALAYA
793001
India 
Phone  9918000079  
Fax    
Email  scsmeghalaya2004@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Eliza Dutta 
Designation  Assistant Professor 
Affiliation  Indian Institute of Public Health 
Address  Indian Institute of Public Health, Shillong, Lawmali, Pasteur Hill, Shillong

East Khasi Hills
MEGHALAYA
793001
India 
Phone  9823384186  
Fax    
Email  eliza.dutta@iiphs.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Anisha Mawlong 
Designation  Senior Specialist and HOD Radiation Oncology, MBBS and MD 
Affiliation  State Cancer Society of Meghalaya, Civil Hospital Shillong 
Address  Room No 3, Department of Radiation Oncology, DAE-Civil Hospital Cancer Wing Civil Hospital Shillong, Laban

East Khasi Hills
MEGHALAYA
793001
India 
Phone  9436924322  
Fax    
Email  anishamawlong@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SMRATA Trust 
Address  3rd floor Millennium Square Building, Lumbini avenue, Gachibowli Hyderabad, Telangana, 500032 
Type of Sponsor  Other [A Non Profit Organization] 
 
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 
Dr Anisha Mawlong  DAE-Civil Hospital Cancer Wing  Department of Radiation Oncology, Civil Hospital Shillong Laban, Shillong
East Khasi Hills
MEGHALAYA 		 9436924322

anishamawlong@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Pasteur Institute (IECPI)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chemo-Radiation only.  Chemoradiation is a standard treatment given to cancer patients which involves use of ionizing radiation and chemotherapy simultaneously. It involves external beam Radiotherapy daily for a period of 25 to 35 days depending on the site of the disease. Along with this, patient also receive chemotherapy once a week for a total of five to seven weeks.  
Intervention  virtual device assisted guided imagery plus chemo-radiation  Virtual device assisted guided imagery plus chemo-radiation. The guided imagery programme consists of ten audio-visuals customized addressing needs specific to cancer patients undergoing chemo-radiation therapy, such as nausea, fatigue, diarrhea, pain, anxiety etc. (appendix ). We have translated the audio into local language which is Khasi in order to improve acceptability, comprehension and efficacy amongst patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) New patients aged 18 years to 70 years with a confirmed cancer diagnosis and enrolled in chemo-radiation
2) Able to provide informed consent
3) Eastern Cooperative Oncology Group (ECOG) performance status of 0–2 in order to prevent biasness among the patients and to check the patient’s performance status
4) Able to understand and complete the study questionnaires 
 
ExclusionCriteria 
Details  1) Severe cognitive impairment or active psychiatric illness
2) Visual or auditory impairments that would prevent use of the VR device
3) Concurrent participation in other psychosocial interventions
4) History of seizures or motion sickness (contraindicated for VR use) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of Life using the FACT G   Weekly 
 
Secondary Outcome  
Outcome  TimePoints 
Distress reduction using the Distress Thermometer Scale  Weekly 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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   Phase 2 
Date of First Enrollment (India)   08/06/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response (Others) -  De-Identified data for research purpose only with proper justification and subjected to prior consent by the participants.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [scsmeghalaya2004@gmail.com].

  6. For how long will this data be available start date provided 01-11-2026 and end date provided 31-10-2030?
    Response (Others) -  Beginning 5 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   Cancer significantly impacts patients’ mental and physical well-being, with 25% to 60% reporting clinical distress. Chemoradiation, a common treatment, often leads to debilitating side effects. Guided imagery, especially when delivered through virtual reality (VR), has emerged as a promising non-invasive intervention to alleviate distress, reduce pain and anxiety, and improve mood and overall well-being. This study aims to assess the effectiveness of VR-assisted guided imagery in reducing distress among patients undergoing chemoradiation. The hypothesis posits that patients receiving this intervention will show higher quality-of-life scores (FACT-G) compared to those receiving standard care. A quasi-experimental, non-randomized design will be used. 
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