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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049995

Enrollment

310

Registered

2023-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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 interven

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. Timepoint: 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 sessionTimepoint: For 2nd secondary outcome- between baseline and 3, 6 and 12 weeks	—

Measure

Time frame

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. Timepoint: 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 sessionTimepoint: For 2nd secondary outcome- between baseline and 3, 6 and 12 weeks

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Countries

India

Contacts

Public ContactDr Jayita Deodhar

Tata Memorial Hospital

jukd2000@yahoo.co.uk00912224177000

Outcome results