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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

715 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-26

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ENABLE-SG (immediate group)

* 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

Group Type EXPERIMENTAL

ENABLE-SG model

Intervention Type BEHAVIORAL

Patients and caregivers will receive individual structured psycho-educational sessions with a health coach. These sessions will be primarily delivered over the phone. Patient and caregiver dyads will have different health coaches. Patients will have six sessions on the topics of maintaining positivity, self-care, coping with stress, managing symptoms, exploring what matters most, and life review. Caregivers will have four sessions on the topics of maintaining positivity, self-care, coping with stress, and managing symptoms. All sessions will begin with screening for distress using the Distress Thermometer and Problem List culturally adapted from the National Comprehensive Cancer Network. From screening results, the health coach can flexibly change the order of the topics to address specific problems. It will take approximately three months to complete all sessions.

Wait-list control

* 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

Group Type OTHER

Wait-list control

Intervention Type OTHER

* 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

Interventions

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ENABLE-SG model

Patients and caregivers will receive individual structured psycho-educational sessions with a health coach. These sessions will be primarily delivered over the phone. Patient and caregiver dyads will have different health coaches. Patients will have six sessions on the topics of maintaining positivity, self-care, coping with stress, managing symptoms, exploring what matters most, and life review. Caregivers will have four sessions on the topics of maintaining positivity, self-care, coping with stress, and managing symptoms. All sessions will begin with screening for distress using the Distress Thermometer and Problem List culturally adapted from the National Comprehensive Cancer Network. From screening results, the health coach can flexibly change the order of the topics to address specific problems. It will take approximately three months to complete all sessions.

Intervention Type BEHAVIORAL

Wait-list control

* 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

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
4. Able to speak English or Chinese.
5. Able to provide informed consent

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

Exclusion Criteria

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.

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

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes