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

Phase 3

Registration Number: CTRI/2023/02/049995

Lead Sponsor: Applying for intramural funding

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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-Hodgkinâ??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)Timepoint: 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 â??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. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: For 1st secondary outcome - between baseline and 12 weeks <br/ ><br>;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 sessionTimepoint: For 2nd secondary outcome- between baseline and 3, 6 and 12 weeks