FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/049995 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 21/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Brief psychosocial group intervention for initial distress of parents with newly diagnosed chlldren with heamtolymphoid cancers 
Scientific Title of Study   A randomized controlled trial to evaluate adding a brief psychosocial group intervention to usual care on the initial distress of parents of newly diagnosed children with hematolymphoid cancers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayita Deodhar 
Designation  Prof and Phy (Psychiatry) 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Tata Memorial Hospital Dr. E. Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  00912224177000   
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayita Deodhar 
Designation  Prof and Phy (Psychiatry) 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Tata Memorial Hospital Dr. E. Borges Road Parel Mumbai


MAHARASHTRA
400012
India 
Phone  00912224177000   
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Public Query  
Name  Dr Jayita Deodhar 
Designation  Prof and Phy (Psychiatry) 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine Tata Memorial Hospital Dr. E. Borges Road Parel Mumbai


MAHARASHTRA
400012
India 
Phone  00912224177000   
Fax    
Email  jukd2000@yahoo.co.uk  
 
Source of Monetary or Material Support  
Applying for intramural funding - Tata Memorial Hospital, Mumbai, India 
 
Primary Sponsor  
Name  Applying for intramural funding 
Address  Tata Memorial Hospital 
Type of Sponsor  Research institution and hospital 
 
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 Jayita Deodhar  Tata Memorial Hospital  Psycho-oncology Department Room 20 Golden Jubilee Building Basement Dr. E. Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA 		 9892358023

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Parents of children up to 18 years of age, with acute leukemias and Non-Hodgkin’s lymphoma newly diagnosed within 1-2 weeks 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group intervention and usual psychosocial care  Parents randomised to have the experimental intervention will have this in addition to the usual psychosocial care/support. The intervention will be a group intervention, comprising of 2 sessions, each of 90 minutes, conducted 2 weeks apart, combining psycho-education and support. It will be led by a therapist who will be Psychology or Social Work professional. The sessions will follow a specific structure as per a prepared guide. The therapists will undergo prior training. The structure of the sessions will be as follows: Session 1 Session 2 Introduction Recap of previous session Cancer and treatment and hospital resources related information Reiteration of disease/treatment/resources related information Clarification of doubts regarding above Support and sharing Support and sharing Question and answer Learning from each other Plan for follow up session Conclusion Contact details Plan for Conclusion The therapist will remain constant for both intervention sessions conducted for different parent groups. Treatment fidelity will be checked by the senior Psycho-oncologist after each session by discussion with the therapist who conducted the session. Usual psychosocial care All parents, both in the intervention and control arms, will have UPC. They will have their routine meeting with their oncologist. They will have contact with nutritionist and catheter care staff, as per standard care. They will also have contact with the team social worker who can help with resources, information and access to paediatric psycho-oncology specialist, if referral required.  
Comparator Agent  Usual psychosocial care  All parents, both in the intervention and control arms, will have UPC. They will have their routine meeting with their oncologist. They will have contact with nutritionist and catheter care staff. They will also have contact with the team social worker, who can help with resources, information and access to paediatric psycho-oncology specialist, if referral required. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Target population
Parents of newly diagnosed childhood cancer patients registered in Paediatric Oncology Clinic in in a tertiary care cancer centre. We usually see 30-40 patients each month. We aim to recruit parents of 310 patients

Inclusion Criteria
1. Parents of children up to 18 years of age, with acute leukemias and Non-Hodgkin’s lymphoma newly diagnosed within 1-2 weeks
2. Children planned for or starting treatment with curative intent, in the hospital
3. Both parents who can attend both sessions of the intervention and follow up. If not feasible, at least 1 parent who can attend both the sessions (same parent to attend both sessions)
4. Parents and child staying in Mumbai over the next 4 months.
5. Parents able to give informed consent
6. Parents able to speak Hindi/Marathi/English
 
 
ExclusionCriteria 
Details  1. Parents of children up to 18 years of age, with newly diagnosed advanced hematolymphoid cancers, planned for or starting treatment with palliative intent, or for best supportive care or are medically unstable
2. Parents with pre-existing psychiatric disorder or intellectual disability or communication difficulties
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in anxiety scores between baseline and at 3 and 6 weeks, using Generalized Anxiety Disorder -7 (GAD-7)  Between baseline and 3 and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in anxiety and depression scores between baseline and 12 weeks using GAD -7 and PHQ –9. The trial intervention is short, so we do not expect to see much of a difference between the trial groups by 12 weeks (because all parents are likely to have got used to the cancer diagnosis by then), so the aim is to see if distress is similar or perhaps some beneficial effect on distress has been maintained, even if in a few parents.


 		 For 1st secondary outcome - between baseline and 12 weeks
 
2. Change in anxiety and depression between baseline and 3, 6 and 12 weeks of the spouse or partner of the parent who attended the intervention or usual psychosocial care session  For 2nd secondary outcome- between baseline and 3, 6 and 12 weeks  
 
Target Sample Size   Total Sample Size="310"
Sample Size from India="310" 
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 3 
Date of First Enrollment (India)   06/03/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publication till date.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background and rationale:  The diagnosis of a child’s illness like cancer can cause a lot of emotional distress in the parents. This distress can be very high when the child has just received the  diagnosis and treatment plan has to be made. Parents can feel depressed and anxious and can have difficulty in coping during this initial period. In our hospital currently, if parents need some help for their distress, they can seek support from the social worker or counsellor in the Paediatric Oncology department and Psychologist in Psycho-oncology Department. 

 

Aim: The purpose of this study is to whether a standard psychosocial support and standard support along with 2 brief group sessions will help reducing the initial distress of parents of newly diagnosed acute leukemias and non-Hodgkin’s lymphoma, as compared to usual psychosocial care only. 

                                            

 

Methodology: Parents of children newly diagnosed with hematolymphoid cancers (acute leukemia and non-Hodgkin’s lymphoma) will be screened for eligibility for study participation. If eligible, after due consent for the study, parents will be randomly allocated to one of the two groups. The allocation to the study treatments will be done by a randomization process. This process involves an unbiased process of selection of the treatment arm similar to the toss of a coin. The investigators will not know the treatment arm that you are assigned to. There will be equal chance of being assigned to either of the treatment arms.

 

Treatment arm 1 - Group intervention + Usual psychosocial care: 

This will comprise of 2 sessions, each of 90 minutes, which will be at interval of 2 weeks. The 1st session will within 2 weeks after your child’s diagnosis is confirmed and treatment has been planned. The 2nd session will be 2 weeks after the 1st session. The group will comprise of the research team member/s who will conduct the session and parents of other children who have consented to take part in the study. Each session will be conducted by the Psychologist in the research team. The sessions are meant for providing information, discussing and sharing your concerns and coping, and practical problem solving. Participants will also receive usual psychosocial care  (UPC) in which they will have their routine meeting with their oncologist. They will also have contact with the  team social worker who can help with resources and information. They will have contact with the nutrition and catheter care clinic. They can be referred to  or access the specialist child psychologist working with children with cancer, if required.

 

Treatment arm 2 - Usual psychosocial care  (UPC): 

In this, the participating parents will have their routine meeting with their oncologist. They will also have contact with the  team social worker who can help with resources and information. They will have contact with the nutrition and catheter care clinic. They can be referred to or access the specialist child psychologist working with children with cancer, if required.

 

Measures: Basic information like age, gender, contact details and income. We will obtain the medical details of your child from the medical records (electronic and/or paper). 

 

Following questionnaires will be filled, either by the parents or the study team member if parents are unable to do so.

 

Patient Health Questionnaire-9 (PHQ-9) - to assess mood. This questionnaire has 9 questions which will take 5 minutes to complete. This will be completed at 4 time points - before the study begins, in 3rd week, 6th-7thweek and 12th week after the study starts. 

 

Generalized Anxiety Disorder-7 (GAD-7) - has 7 questions about anxiety symptoms and will take 5 minutes to complete. It will be done again at 4 time points - before the study begins, in 3rd week, 6th-7th week and 12thweek after the study starts.

 

Interview – In addition to the above, for those who are randomized to the treatment arm1, some parents will be invited  to take part in an interview understand their experience of the treatment and how it may have helped the parents.

 

The parents’ participation in the study will be for 12-14 weeks, till all the assessments are over.

 

We plan to enroll parents of 310 children over a period of 3 years.

 

Analysis: We will measure the change in the anxiety and depression scores of the parents at 

3, 6 and 12 weeks, using appropriate statistical tests. We will identify the main themes arising from the interviews done with the selected participating parents.

 

Risks: This is a psychosocial intervention study. There are no invasive procedures for the participants. If any parent experiences any discomfort related to the intervention or interviews, psychosocial support will be provided by the mental health professional in the study team.

 

Significance: This study will help us to examine if a brief psychosocial group intervention will be reduce anxiety and depression and help us explore coping in parents of children newly diagnosed with haematolymphoid cancers in our centre in a low middle income country. If proven to be of benefit, this intervention can be widely implemented and should become standard of care in paediatric psychosocial oncology practice.

 
Close