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CTRI Number  CTRI/2024/09/073440 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Group Therapy for psychological issues following brain tumour diagnosis 
Scientific Title of Study   Group Intervention for Adjustment to Primary Brain Tumour in Neuro-Oncological Disorders: A Randomized Single Group Trial 
Trial Acronym  GrAntH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hubert Dan V 
Designation  Ph.D. Scholar 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru 
Address  Dept. of Psychiatric Social Work, Dr. MV Govindaswamy building, NIMHANS, Bengaluru -29.
Dept. of Psychiatric Social Work, Dr. MV Govindaswamy building, NIMHANS, Bengaluru -29.
Bangalore
KARNATAKA
560029
India 
Phone  7019099238  
Fax    
Email  hubertdan80@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr L Ponnuchamy 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru 
Address  Dept. of Psychiatric Social Work, Dr. MV Govindaswamy building, NIMHANS, Bengaluru -29.

Bangalore
KARNATAKA
560029
India 
Phone  7358466735  
Fax    
Email  ponnupsw@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr L Ponnuchamy 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru 
Address  Dept. of Psychiatric Social Work, Dr. MV Govindaswamy building, NIMHANS, Bengaluru -29.


KARNATAKA
560029
India 
Phone  7358466735  
Fax    
Email  ponnupsw@gmail.com  
 
Source of Monetary or Material Support  
University Grants Commission and National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road, Bengaluru - 29. 
 
Primary Sponsor  
Name  Hubert Dan V 
Address  PhD Scholar, Department of Psychiatric Social Work, Dr. MV Govindaswamy Centre, National Institute of Mental Health and Neurosciences, Hosur Road, Bengaluru -29. 
Type of Sponsor  Other [Self] 
 
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 
Prof Dr Dhaval Shukla  National Institute of Mental Health and Neuro Sciences(NIMHANS)  Department of Neurosurgery, IInd Floor, Neuroscience Faculty Block,
Bangalore
KARNATAKA 		 08026995403
08026564830
surgery@nimhans.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Behavioural Science Division), NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges, (2) ICD-10 Condition: C709||Malignant neoplasm of meninges, unspecified, (3) ICD-10 Condition: C71||Malignant neoplasm of brain, (4) ICD-10 Condition: D09||Carcinoma in situ of other and unspecified sites, (5) ICD-10 Condition: D32||Benign neoplasm of meninges, (6) ICD-10 Condition: D33||Benign neoplasm of brain and otherparts of central nervous system, (7) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain, (8) ICD-10 Condition: F32||Major depressive disorder, singleepisode, (9) ICD-10 Condition: F33||Major depressive disorder, recurrent, (10) ICD-10 Condition: F34||Persistent mood [affective] disorders, (11) ICD-10 Condition: F39||Unspecified mood [affective] disorder, (12) ICD-10 Condition: F43||Reaction to severe stress, and adjustment disorders, (13) ICD-10 Condition: F41||Other anxiety disorders, (14) ICD-10 Condition: F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Phase 1: Pilot testing of Group intervention for adjustment to primary brain tumour  Qual 1: Qualitative interviews with 16 patients individually, 3 Focus Group Discussions (FGDs) with total of 16 patients, Expert-Panel Consultation with 12 field experts for Assessment of Feasibility. Quan 1: Pilot testing of intervention for 12 patients with pre-test and post-test assessments to be delivered in six sessions based on the themes of i. Symptom burden; ii. Helplessness, hopelessness and anxious preoccupations; iii. Finding emotional support; iv. Developing resilience and reviving fighting spirit; v. Dealing with uncertainty; vi. Seeking professional help. Total duration of the pilot would be 4 months from the date of CTRI registration.  
Intervention  Phase 2: Group intervention for adjustment to primary brain tumour  Intervention: Intervention for 75 patients delivered with pre-test and post-test assessments in six sessions based on the themes of i. Symptom burden, ii. Helplessness, hopelessness and anxious preoccupations, iii. Finding emotional support, iv. Developing resilience and reviving fighting spirit, v. Dealing with uncertainty, vi. Seeking professional help. The 75 patients would be formed in groups of at least 5 or maximum of 8 participants. Follow-Up assessments with 75 patients would be conducted at 1st and 3rd month from the date of surgery. Total duration of the intervention is estimated to be 6 months from the date of recruitment of first participant in this phase.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients who can follow English, Hindi, Tamil, Kannada.
 
 
ExclusionCriteria 
Details  FOR PATIENTS - i) Patients diagnosed with metastatic brain tumour as per histopathological report. ii) Patients with history of neuro-developmental disorders leading to mental retardation. iii) Patients with organic mental illness, i.e. phenomena known to occur as a direct consequence of malignant entity’s interaction with brain in form of growth of tumour; i.e., screening tool HMSE score below 19. iv) Patients experiencing cognitive impairment as a consequence/sequela of pharmacological or neurosurgical interventions for disorders; i.e., screening tool HMSE score below 19.
FOR EXPERTS - i) Non-academicians, i.e., those working professionals below the cadre of lecturer/assistant professor 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Adjustment to illness (as assessed by Mini-MAC score)  1. Baseline i.e. at pre-surgery stage, before the first group intervention session.
2. One week from the baseline, i.e. after the last group intervention session.
3. Follow-up after four weeks from the date of surgery.
4. Follow-up after twelve weeks from the date of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Symptom burden (of psychological issues, as assessed by DASS-21 score)  1. Baseline i.e. at pre-surgery stage, before the first group intervention session.
2. One week from the baseline, i.e. after the last group intervention session.
3. Follow-up after four weeks from the date of surgery.
4. Follow-up after twelve weeks from the date of surgery. 
Quality of life (health related, asassessed by CDC HrQOL-14 score)  1. Baseline i.e. at pre-surgery stage, before the first group intervention session.
2. One week from the baseline, i.e. after the last group intervention session.
3. Follow-up after four weeks from the date of surgery.
4. Follow-up after twelve weeks from the date of surgery. 
 
Target Sample Size   Total Sample Size="115"
Sample Size from India="115" 
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)   16/09/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    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 [hubertdan80@gmail.com].

  6. For how long will this data be available start date provided 29-01-2026 and end date provided 31-12-2030?
    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  
Background:
In the recent decade, psycho-oncology has gained wider attention worldwide, with exploration into the nuances of health and specific theoretical foundations has provided major insights for designing and implementing evidence-based interventions. However, group interventions as a powerful modality and medium of change has not been used before in the context of psycho-oncology in NIMHANS and seldom implemented in the cancer centres in the country with a plan of outcome measurement and analysis. The current study aims to address the psychological, social, and behavioural needs, challenges, and risks of major mood(affective) disorders among adults with neuro-oncological care.
Methodology:
Aim: â€œTo study the effects of group intervention with respect to Adjustment to Primary Brain Tumour and other associated measures among adults with Neuro-Oncological Disorders”. Objectives: 1. To develop an indigenous Group intervention module for adults with neuro-oncological disorders (i.e., primary brain tumours). 2. To assess the feasibility of the Group intervention and acceptability of scales for persons with neuro-oncological disorders (i.e., primary brain tumours). 3. To implement the group intervention and assess the changes in symptom burden, adjustment to illness and health-related quality of life of persons with neuro-oncological disorders (i.e., primary brain tumours). Research design: The study is based on a mixed method research design has two phases. First phase would entail qualitative methodology consisting of Interviews and Focus Group Discussions to construct manual of group intervention, where sample size would depend upon data saturation. In the second phase a single group trial (without control) would be conducted where 75 patients would be allotted to group intervention (each group consisting of at least6 sessions) in hybrid mode with active data collection in 6 months. The patient groups would be followed up after 1 month and 3 months period through telephonic/online/in-person medium.
Keywords: Brain Tumour, Adjustment to Illness, Cancer care. Quality of Life
 
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