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

NCT06044441 | Recruiting

• 2 other identifiers: ENABLE-SGHCSAINV23jan-0001
• Study Type: interventional
• Target: 715
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life of patients with advanced cancer

  Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal), a 46-item measure with a quality of life scale (4 domains: physical, emotional, social, and functional well-being) and a palliative care subscale. It has demonstrated internal consistency, reliability and validity for persons with advanced cancer. Scores range from 0 to 184, with higher scores indicating better quality of life.

  6th month.

Secondary Outcomes (10)

• Health-related quality of life of caregivers

  6th month.

• Longitudinal changes in health-related quality of life of patients with advanced cancer across assessment timepoints

  Baseline, 3rd month, 6th month, 9th month, 12th month.

• Longitudinal changes in health-related quality of life of caregivers across assessment timepoints

  Baseline, 3rd month, 6th month, 9th month, 12th month.

• Mood of patients with advanced cancer and their caregivers

  Baseline, 3rd month, 6th month, 9th month, 12th month.

• Coping strategies of patients with advanced cancer and their caregivers

  Baseline, 3rd month, 6th month, 9th month, 12th month.

Other Outcomes (5)

• Acceptability and adoption of ENABLE-SG among patients with advanced cancer and their caregivers.

  At the end of study participation, up to the 12th month.

• Appropriateness and feasibility of ENABLE-SG among patients with advanced cancer, their caregivers, and healthcare providers

  ≥6 months after baseline.

• Fidelity of the delivery of ENABLE-SG

  Through study completion, anticipated up to 3 years.

Study Arms (2)

ENABLE-SG (immediate group)

EXPERIMENTAL

* 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

Behavioral: ENABLE-SG model

Wait-list control

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

Other: Wait-list control

Interventions

ENABLE-SG model 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.

ENABLE-SG (immediate group)

Wait-list control 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

Wait-list control

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Medical record documentation of an active severe mental illness, dementia, active suicidal ideation, uncorrected hearing loss
• Unable to complete patient-reported outcome measures
• Has been reviewed by palliative care services in the current model of palliative care.
• Self-reported severe mental illness, dementia, active suicidal ideation, uncorrected hearing loss
• Unable to complete caregiver-reported outcomes.
• Healthcare professionals that are not providing care for cancer patients.
• Unable to complete interviews.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre Singapore

Singapore, 168583, Singapore

RECRUITING

Related Publications (7)

• 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.

  PMID: 32023157 BACKGROUND

• 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.

  PMID: 15130218 BACKGROUND

• 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.

  PMID: 22573470 BACKGROUND

• 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.

  PMID: 19690306 BACKGROUND

• 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.

  PMID: 25800768 BACKGROUND

• 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.

  PMID: 25800762 BACKGROUND

• Ke Y, Cheung YB, Bakitas M, Odom JN, Lum E, Tan DSW, Tan TJ, Finkelstein E, Oh HC, Zhou S, Yang GM. 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. BMC Palliat Care. 2024 Jan 30;23(1):29. doi: 10.1186/s12904-024-01353-2.

  PMID: 38287335 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Grace M Yang, MRCP

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace M Yang, MRCP

CONTACT

+65 63065844; grace.yang.m.j@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 21, 2023
• Study Start: December 26, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)