Randomized controlled trial (RCT) of symptom screening with targeted early palliative care (STEP) versus usual care in patients with advanced cancer
Journal of Clinical Oncology
; 40(16), 2022.
Artigo
em Inglês
| EMBASE | ID: covidwho-2005715
ABSTRACT
Background:
To direct limited specialized palliative care resources to patients in greatest need, we developed STEP (Symptom screening with Targeted Early Palliative care). STEP entails symptom screening (ESAS-r) at each oncology clinic visit and triggered alerts (for moderate-high physical and psychological symptoms) to a nurse who calls the patient to offer a palliative care clinic (PCC) visit. We conducted a phase III RCT to assess the impact of STEP versus usual care on quality of life and other patient-reported outcomes (PROs).Methods:
Adults with advanced cancer were recruited from medical oncology clinics at the Princess Margaret Cancer Centre, Toronto, Canada. Consenting patients with oncologist-assessed ECOG 0-2 and estimated survival of 6-36 months were enrolled and block randomized (stratified by tumour site and symptom severity) to STEP or usual care. Participants completed measures of quality of life (FACT-G7), depression (PHQ-9), symptom control (ESASr-CS), and satisfaction with care (FAMCARE-P16) at baseline, 2, 4 and 6 months. The primary outcome was FACT-G7 at 6 months, with a planned sample size of 261/arm.Results:
From 8/2019 to 3/2020, 69 patients were enrolled 33 randomized to STEP and 36 to usual care. The trial was then halted permanently due to the COVID-19 pandemic, owing to substantial changes to elements of STEP (shift to virtual symptom screening and palliative care) and usual care (shift to virtual oncology care). Median age was 64 years (range 25-87) and 62% (43/69) were women;study arms were balanced at baseline except gender, with more women randomized to STEP. Within the STEP arm, 20 (61%) participants triggered a nurse's call to offer a PCC visit, of whom 13 attended the clinic at least once. All outcomes tended to be better in the STEP arm compared to usual care, particularly depression and satisfaction with care at 6 months;however, results were not statistically significant (Table).Conclusions:
STEP holds promise for improving quality of life and other PROs in patients with advanced cancer and effectively directing early palliative care towards those who need it most. In response to the pandemic, an online version of STEP has been developed and a further trial is in progress.
adult; advanced cancer; Canada; cancer center; cancer patient; cancer survival; conference abstract; controlled study; coronavirus disease 2019; depression; female; gender; human; major clinical study; male; middle aged; nurse; oncologist; outcome assessment; palliative therapy; pandemic; Patient Health Questionnaire 9; patient-reported outcome; phase 3 clinical trial; quality of life; randomized controlled trial; sample size; satisfaction; survival
Texto completo:
Disponível
Coleções:
Bases de dados de organismos internacionais
Base de dados:
EMBASE
Tipo de estudo:
Estudo experimental
/
Ensaios controlados aleatorizados
Idioma:
Inglês
Revista:
Journal of Clinical Oncology
Ano de publicação:
2022
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS