ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a proactive palliative care model: protocol for a hybrid type 1 effectiveness-implementation randomized wait-list controlled trial

• Published in: BMC palliative care 2024-01, Vol.23 (1), p.29-14, Article 29
• Main Authors: Ke, Yu, Cheung, Yin Bun, Bakitas, Marie, Odom, J Nicholas, Lum, Elaine, Tan, Daniel Shao Weng, Tan, Tira J, Finkelstein, Eric, Oh, Hong Choon, Zhou, Siqin, Yang, Grace Meijuan
• Format: Article
• Language: English
• Subjects: Adult; Cancer; Caregivers; Chinese languages; Coping; Cost benefit analysis; Decision making; Dementia; Health coaching; Hearing loss; Hospice and Palliative Care Nursing; Humans; Implementation; Informed consent; Mental disorders; Methods; Neoplasms - therapy; Oncology; Palliative care; Palliative Care - methods; Palliative treatment; Patients; Practice; Psychoeducational; Quality of Life; Randomized Controlled Trials as Topic; Singapore; Stress management; Study Protocol; Suicidal behavior; Symptom management; Telehealth; Telemedicine; Terminal Care - methods
• ISSN: 1472-684X; 1472-684X
• DOI: 10.1186/s12904-024-01353-2

Specialist palliative care is often provided late in the patient's disease trajectory in response to uncontrolled symptoms. Shifting from this reactionary illness-stress paradigm to a proactive health-wellness approach, the ENABLE (Educate, Nurture, Advise, Before Life Ends) telehealth model aims to enhance the coping, stress and symptom management, self-care, and advance care planning skills of patients with advanced cancers and their caregivers. The ENABLE model has been culturally adapted to Singapore (ENABLE-SG) and pilot-tested. A hybrid type 1 effectiveness-implementation design will be used to evaluate the effectiveness of ENABLE-SG while collecting real-world implementation data. This single-centre, assessor-blind, wait-list (immediately vs. 6 months) randomized controlled trial will recruit 300 adult patients within 60 days of an advanced cancer diagnosis and their family caregivers from the National Cancer Centre of Singapore. ENABLE-SG comprises structured psychoeducational sessions with a telehealth coach, covering essential topics of early palliative care. Participants will be assessed at baseline and every 3 months until patient's death, 12 months (caregivers), or end of study (patients). The primary outcome is patient quality of life 6 months after baseline. Secondary patient-reported outcomes include mood, coping, palliative care concerns, and health status. Secondary caregiver-reported outcomes include caregiver quality of life, mood, coping, and care satisfaction. Mixed-effects regression modelling for repeated measurements will be used. To assess the effectiveness of ENABLE-SG versus usual care, patient and caregiver outcomes at 6 months will be compared. To compare earlier versus delayed ENABLE-SG, patient and caregiver outcomes at 12 months will be compared. Within the hybrid type 1 effectiveness-implementation design, implementation outcomes will be evaluated in both the early and delayed groups. Acceptability, adoption, appropriateness, and feasibility will be assessed using a feedback survey and semi-structured interviews with a purposive sample of patients, caregivers, and healthcare providers. Transcribed interviews will be analysed thematically. Other implementation outcomes of penetration, fidelity, and cost will be assessed using records of study-related processes and summarized using descriptive statistics. A cost-effectiveness analysis will also be conducted. This study will assess both effectiveness and implementation of ENA