Clinical trial NCT06044441: Evaluation and Implementation Preparation of a Proactive Palliative Care Model (ENABLE-SG)
Official title: ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a Proactive Palliative Care Model: Evaluation and Implementation Preparation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: Palliative Care
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 715
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life of patients with advanced cancer
timeFrame: 6th month.
Secondary outcomes:
measure: Health-related quality of life of caregivers
timeFrame: 6th month.
measure: Longitudinal changes in health-related quality of life of patients with advanced cancer across assessment timepoints
timeFrame: Baseline, 3rd month, 6th month, 9th month, 12th month.
measure: Longitudinal changes in health-related quality of life of caregivers across assessment timepoints
timeFrame: Baseline, 3rd month, 6th month, 9th month, 12th month.
measure: Mood of patients with advanced cancer and their caregivers
timeFrame: Baseline, 3rd month, 6th month, 9th month, 12th month.
measure: Coping strategies of patients with advanced cancer and their caregivers
timeFrame: Baseline, 3rd month, 6th month, 9th month, 12th month.
measure: Palliative care concerns of patients with advanced cancer
timeFrame: Baseline, 3rd month, 6th month, 9th month, 12th month.
measure: Health states of patients with advanced cancer
timeFrame: Baseline, every 3 months until death or end of the study.
measure: Healthcare resource utilization of patients with advanced cancer
timeFrame: Baseline until death or end of the study.
measure: Caregivers' satisfaction with care
timeFrame: Baseline, 3rd month, 6th month, 9th month, 12th month.
measure: Healthcare resource utilization of caregivers
timeFrame: Baseline, 3rd month, 6th month, 9th month, 12th month.
Other outcomes:
measure: Acceptability and adoption of ENABLE-SG among patients with advanced cancer and their caregivers.
timeFrame: At the end of study participation, up to the 12th month.
measure: Appropriateness and feasibility of ENABLE-SG among patients with advanced cancer, their caregivers, and healthcare providers
timeFrame: ≥6 months after baseline.
measure: Fidelity of the delivery of ENABLE-SG
timeFrame: Through study completion, anticipated up to 3 years.
measure: Implementation cost
timeFrame: Through study completion, anticipated up to 3 years.
measure: Penetration
timeFrame: Through study completion, an average of 2 years.
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Grace M Yang, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hui D, Bruera E. Models of Palliative Care Delivery for Patients With Cancer. J Clin Oncol. 2020 Mar 20;38(9):852-865. doi: 10.1200/JCO.18.02123. Epub 2020 Feb 5.
citation: Bakitas M, Stevens M, Ahles T, Kirn M, Skalla K, Kane N, Greenberg ER; Project Enable Co-Investigators. Project ENABLE: a palliative care demonstration project for advanced cancer patients in three settings. J Palliat Med. 2004 Apr;7(2):363-72. doi: 10.1089/109662104773709530.
citation: Maloney C, Lyons KD, Li Z, Hegel M, Ahles TA, Bakitas M. Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens. Palliat Med. 2013 Apr;27(4):375-83. doi: 10.1177/0269216312445188. Epub 2012 May 9.
citation: Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
citation: Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, Dionne-Odom JN, Frost J, Dragnev KH, Hegel MT, Azuero A, Ahles TA. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1438-45. doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23.
citation: Dionne-Odom JN, Azuero A, Lyons KD, Hull JG, Tosteson T, Li Z, Li Z, Frost J, Dragnev KH, Akyar I, Hegel MT, Bakitas MA. Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1446-52. doi: 10.1200/JCO.2014.58.7824. Epub 2015 Mar 23.