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. 2019 Jul 2;2019(7):CD012582. doi: 10.1002/14651858.CD012582.pub2

Safarabadi‐Farahani 2016.

Methods Randomised controlled trial
Participants Inclusion criteria: primary caregivers of a child with active cancer were eligible if: they were residents of Tehran; aged > 18 years; patient started treatment process; child aged < 14 years; had access to a telephone at home; and were willing to participate and provide written consent.
Exclusion criteria: none specified
Number randomised: 65 randomised, 3 withdrew due to patient death; 31 intervention group, 31 control group.
Follow‐up: baseline, postintervention, 30 days
Setting: hospital and rehabilitation complex in Tehran, Iran
Interventions Intervention group: the Brief Psychosocial Intervention plus usual support services. Caregivers were provided with information and support through individual counselling sessions delivered by a trained social worker in 60–90 minutes. Specified sessions goals were: 1. engage and motivate caregivers to participate and develop open communication with social worker; 2. develop optimistic attitude, help maintain hope and focus on achievable short‐term goals; 3. provide information about treatments and medication, help caregivers learn to live with uncertainty; 4. help caregivers cope with stress and teach stress‐relieving techniques, coping strategies, and healthy lifestyle behaviours; and 5. educate self‐care strategies. After each session, caregivers received a homework assignment. Every session was followed up with a telephone call (30–45 minutes).
Control group: usual services, including counselling and financial support
Outcomes
  • QoL (Caregiver QoL Index Cancer, Persian version)

Notes 48% neuro‐oncology (65 participants randomised, 31 intervention group, 31 control group. In total, 31 caregivers of patients with brain tumours were included).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Method of randomisation not described in the report. Authors clarified that a member of the team would alternate group allocation in consecutive participants (i.e. sequence was not random).
Allocation concealment (selection bias) High risk Not described in the report ('centrally randomised'). Based on the author's explanations, we concluded that allocation concealment was not realistically possible.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible due to nature of intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not clear if statistician was blinded. Authors explained that statistician was not in contact with cases, and would only see study case numbers.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3 study participants dropped out before the baseline assessment. No further information on attrition or how missing data were handled in the report. Authors confirmed that there was no missing data (all questionnaires were checked directly following completion) and that no further attrition took place.
Selective reporting (reporting bias) Unclear risk No published protocol.