Brief psychosocial group intervention for initial distress of parents with newly diagnosed chlldren with heamtolymphoid cancers

Phase 3

Not yet recruiting

• Conditions: Parents of children up to 18 years of age, with acute leukemias and Non-Hodgkin’s lymphoma newly diagnosed within 1-2 weeks

• Registration Number: CTRI/2023/02/049995
• Lead Sponsor: Applying for intramural funding

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-21
• Study Start: 2023-06-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Jayita Deodhar

Principal investigator

9892358023

jukd2000@yahoo.co.uk