Evaluation and Implementation Preparation of a Proactive Palliative Care Model (ENABLE-SG)

National Cancer Centre, Singapore

Status: Enrolling

Conditions: Neoplasms

Treatments: Behavioral: ENABLE-SG model; Other: Wait-list control

Study type: Interventional

Funder types: Other

Identifiers

NCT06044441

ENABLE-SG

HCSAINV23jan-0001 (Other Grant/Funding Number)

Details and patient eligibility

About

The current interdisciplinary specialist palliative care model focuses on supporting patients with advanced cancer who have complex problems in the last weeks of life. Consequently, palliative care is often provided late and in response to uncontrolled symptoms during crises. Palliative care models should shift from this reactionary illness-stress paradigm to a proactive health-wellness approach that is integrated early in the patient's disease trajectory.

A proactive early palliative care telehealth model, ENABLE (Educate, Nurture, Advise, Before Life Ends), was developed in the U.S. to coach patients with advanced cancers and their family caregivers on how to cope effectively with serious illness. By empowering individuals early before acute distress and symptoms occur, patients and families can better mitigate and avoid crises. Building on positive health outcomes demonstrated by the ENABLE model in the U.S., the study team has successfully pilot-tested a culturally adapted ENABLE-SG model in Singapore. This study seeks to test the effectiveness of this ENABLE-SG model among patients with recently diagnosed advanced cancer and their caregivers while simultaneously collecting data on real-world implementation.

Full description

To evaluate the effectiveness of the ENABLE-SG model, we will conduct a randomized wait-list controlled trial comparing clinical outcomes at 6 months between patients and caregivers receiving early ENABLE-SG and their wait-listed counterparts receiving usual care. Eligible patients and their caregivers will be randomly assigned at baseline to receive ENABLE-SG either immediately or after a 6-month waiting period. To evaluate ways to improve implementation, the Consolidated Framework for Implementation Research (CFIR) will be used to systematically identify processes that influence implementation outcomes.

The specific aims and hypotheses of this study are:

1. Assess the effectiveness of ENABLE-SG among patients with advanced cancer. We hypothesize that at 6 months, compared to usual care, patients who received ENABLE-SG will have better health-related quality of life (QoL), mood, health status, coping strategies, lesser palliative care concerns, lesser acute healthcare utilisation, and smaller hospital bill size. At 12 months, compared to wait-list control group, early ENABLE-SG recipients will have better primary and secondary outcomes.
2. Assess the effectiveness of ENABLE-SG among caregivers of patients with advanced cancer. We hypothesize that at 6 months, compared to usual care, caregivers who received ENABLE-SG will have better caregiver health-related QoL, mood, coping strategies, satisfaction with care, and lower caregiving costs. At 12 months, compared to wait-list control group, early ENABLE-SG recipients will have better primary and secondary outcomes.
3. Assess ways to improve ENABLE-SG implementation in the real-world context.

Enrollment: 715 estimated patients

Sex: All

Ages: 21 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Inclusion criteria for patients:

  1. Adult aged 21 and above
  2. Within 60 days of being informed of an advanced cancer diagnosis, defined as metastatic or recurrent/ progressive Stage III/IV solid tumour
  3. Able to speak English or Chinese
  4. Able to provide informed consent
  5. Patients will NOT need to have a caregiver willing to participate in the ENABLE-SG programme.

• Inclusion criteria for caregivers:

  1. Adult aged 21 and above
  2. Self-endorsing or identified by the enrolled patient as an unpaid spouse/partner, relative or friend who knows them well and who provides regular support (at least 7 hours a week) due to their cancer and who does not have to live in the same dwelling
  3. Caring for a patient with advanced cancer (see definition under patient inclusion criteria above)
  4. Able to speak English or Chinese.
  5. Able to provide informed consent

• Inclusion criteria for healthcare professions:

  1. 21 years or older.
  2. Approached to participate in the ENABLE-SG study
  3. Able to provide informed consent

Exclusion criteria

• Exclusion criteria for patients:

  1. Medical record documentation of an active severe mental illness, dementia, active suicidal ideation, uncorrected hearing loss
  2. Unable to complete patient-reported outcome measures
  3. Has been reviewed by palliative care services in the current model of palliative care.

• Exclusion criteria for caregivers:

  1. Self-reported severe mental illness, dementia, active suicidal ideation, uncorrected hearing loss
  2. Unable to complete caregiver-reported outcomes.

• Exclusion criteria for healthcare professional:

  1. Healthcare professionals that are not providing care for cancer patients.
  2. Unable to complete interviews.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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715 participants in 2 patient groups

ENABLE-SG (immediate group)

Experimental group

Description:

* Participants will receive the ENABLE-SG model immediately (six sessions for patients and four sessions for caregivers) at an approximately weekly interval. * Interventions: ENABLE-SG model

Treatment:

Behavioral: ENABLE-SG model

Wait-list control

Other group

Description:

* 6-month wait-list control. Participants will receive the ENABLE-SG model six months after baseline (six sessions for patients and four sessions for caregivers) at an approximately weekly interval. * Interventions: ENABLE-SG model

Treatment:

Other: Wait-list control