Raja Pramanik 1 , Sandeep Agarwala 2 , Vishnubhatla Sreenivas 3 , Deepa Dhawan 1 , Sameer Bakhshi 4 Show Affiliations »
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OBJECTIVE: Health-related quality of life (HRQoL ) is an important outcome for paediatric cancer studies. We compared the HRQoL between patients of progressive paediatric solid tumours randomised to metronomic chemotherapy versus placebo . METHODS: In this double-blinded, placebo -controlled randomised study of 108 children with progressive malignancies, HRQoL was evaluated using the PedsQOL Cancer module V.3 at baseline (A1), A2 (9 weeks or earlier if progressed) or A3 (18 weeks or earlier if progressed ). RESULTS: There was no statistically significant difference in the change in quality of life produced by each arm from A1 to A2 in either mean total scores or individual domain scores, reported by children or their parents. On analysing the response according to the minimal clinically important difference, defined as an improvement by 4.5 points, we found no significant differences, be it among bone-sarcomas, other tumours, responders (those who received ≥9 weeks of treatment) or non-responders. CONCLUSIONS: The present study concludes that there was no significant difference in HRQoL , between the patients in the two arms at second and later assessments. This is consistent with the other survival endpoints in the study. TRIAL REGISTRATION NUMBER: Clinical trial registration: clinicaltrials.gov Identifier: NCT01858571. © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.
RCT Entities: Population
Interventions
Outcomes
OBJECTIVE: Health-related quality of life (HRQoL) is an important outcome for paediatric cancer studies. We compared the HRQoL between patients of progressive paediatric solid tumours randomised to metronomic chemotherapy versus placebo. METHODS: In this double-blinded, placebo-controlled randomised study of 108 children with progressive malignancies , HRQoL was evaluated using the PedsQOL Cancer module V.3 at baseline (A1), A2 (9 weeks or earlier if progressed) or A3 (18 weeks or earlier if progressed). RESULTS: There was no statistically significant difference in the change in quality of life produced by each arm from A1 to A2 in either mean total scores or individual domain scores, reported by children or their parents. On analysing the response according to the minimal clinically important difference, defined as an improvement by 4.5 points, we found no significant differences, be it among bone-sarcomas , other tumours , responders (those who received ≥9 weeks of treatment) or non-responders. CONCLUSIONS: The present study concludes that there was no significant difference in HRQoL, between the patients in the two arms at second and later assessments. This is consistent with the other survival endpoints in the study. TRIAL REGISTRATION NUMBER: Clinical trial registration: clinicaltrials.gov Identifier: NCT01858571. © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Entities: Disease
Species
Keywords:
cancer; paediatrics; quality of life
Year: 2021
PMID： 33468507 DOI： 10.1136/bmjspcare-2020-002731
Source DB: PubMed Journal: BMJ Support Palliat Care ISSN： 2045-435X Impact factor: 3.568