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CTRI Number  CTRI/2024/01/061361 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 12/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Convenience of psychological treatment among individuals whose parents have cancer 
Scientific Title of Study   Feasibility of Psychological Intervention among Individuals with Parental Cancer 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha Goel 
Designation  MPhil Clinical Psychology trainee 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9602680878  
Fax    
Email  megha.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Shwetha T S 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880993080  
Fax    
Email  shwetha.ts@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Karthik S Udupa 
Designation  Professor and Head of the Department 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Medical Oncology, Kasturba Medical College, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845317153  
Fax    
Email  udupa.karthik@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, Manipal Academy of Higher Education. Pin 576104 
 
Primary Sponsor  
Name  Megha Goel 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal-576104 
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 
Dr Karthik Udupa  Kasturba Hospital  Dept of Medical Oncology, Kasturba Medical College, Manipal
Udupi
KARNATAKA 		 9845317153

udupa.karthik@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  nil health conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Psychological intervention  The individuals will be given questionnaires, general health questionnaire, Revised Collet-Lester Fear of Death and Dying Scale, Intolerance of Uncertainty Scale, Singhs Psychological hardiness scale. on the basis of the scales, three sessions will be given, for psychoeducation, practicing gratitude, cognitive retraining, hardiness skills and relaxation. after this the questionnaires will be administered again after the intervention to assess change. each session will be of approximately forty minutes for three weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Both males and females
Individuals whose parent has been diagnosed with any type of cancer
The individuals with parental cancer must be age between 18-30 years
Both the parents of the individual must be living 
 
ExclusionCriteria 
Details  The individual must not have any organic mental disorder like dementia, delirium
The individual must not have severe depression, psychotic disorders
Individuals undergoing any form of psychological intervention in past 6 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Scores on variables death anxiety, intolerance of uncertainty and psychological hardiness before and after intervention  Scores on variables death anxiety, intolerance of uncertainty and psychological hardiness before and after intervention; that is at the baseline and after three weeks of the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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
Modification(s)  		 N/A 
Date of First Enrollment (India)   17/01/2024 
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="0"
Months="4"
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 - NO
Brief Summary   The present study is an intervention study in which the participants shall be given questionnaires to assess their levels of death anxiety, intolerance of uncertainty and psychological hardiness; after this, a three session psychological intervention would be done. after that the questionnaires would be filled again, to get a measure of pre and post intervention scores on the basis of the intervention. individuals with parental cancer are vulnerable to several mental health problems, with questioning of one’s own mortality. individuals may or may not be vocal about it, yet the element of death seeps into the layers of their mind, the moment they hear their parent have been diagnosed with cancer. Genetically loaded disease makes them apprehensive. individuals are aware of the fact that diseases like this may have a genetic component, or may have passing thoughts like, “What if this happens to me?”; cognitions like this do make children with parental cancer fearful and may give rise to several psychopathology. Talking of death and related fears is a taboo in several cultures. One learns directly or indirectly to silence these thoughts as most often children are taught to “Think positive”, yet the very concerns of the children remain unattended to. It is important to speak about these concerns, for existential concerns, as the uncertainty that such diseases like cancer brings with it can be very intolerable, hence affecting them as well. Amidst the physical disease of the patient, healthcare professionals lose sight of the mental wounds of their children. Amidst the rising cases and the increasing number of children having to experience their parents being diagnosed with cancer, is a tough time for them as well. Hence addressing this issue has become the need of the hour. Young adulthood is a transitioning period that comes with its own set of challenges, with regard to developing one’s own identity, forming career and relationships, with need for support and guidance of parents as well. During this stage, ways of dealing with parental cancer need to be built. For, in the current hospital settings, although the issues related to immediate family members are discussed, but there is a lack of action for this population, who needs care and support as well, that goes unnoticed by health professionals. hence, the need arises to address their grievances and provide basic coping skills to deal with the stressful life circumstance at hand. Finally holistic approach not just at an individual level, but also, on a familial level is needed; meaning the biopsychosocial approach that we follow must not only be limited to an individual level, but also be practiced at a larger level.

 
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