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NeoplasmsENABLE-SGNCT06044441

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

A study testing ENABLE-SG model in people with Neoplasms, run by National Cancer Centre, Singapore at 1 site in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 120 yearsHealthy volunteers can take part
Conditions the study is for
Neoplasms
What is being tested?
ENABLE-SG model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
715 participants
Where
1 siteSingapore
Study dates
26 Dec 2023to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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
  • Caring for a patient with advanced cancer (see definition under patient inclusion criteria above)
  • Able to speak English or Chinese.
  • Able to provide informed consent
  • 21 years or older.
  • Approached to participate in the ENABLE-SG study
  • Able to provide informed consent

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Singapore1 site, 1 recruiting
  • National Cancer Centre Singapore

    Singapore, 168583

    Grace M Yang, MRCP, +65 63065844, grace.yang.m.j@singhealth.com.sg

    Grace M Yang, MRCP

    Recruiting

Other trials in Singapore

About this study

Official title: ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a Proactive Palliative Care Model: Evaluation and Implementation Preparation

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.

Read the 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.
Conditions
Neoplasms
Being tested
ENABLE-SG model, Wait-list control
Keywords
Palliative Care
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENABLE-SG modelBehavioural

    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 controlOther

    • 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
Study groups in NCT06044441
Study groupRoleWhat they receive
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
Receives: Behavioral: ENABLE-SG model
Wait-list controlOther* 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
Receives: Other: Wait-list control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6th month.

Secondary outcomes (10)
  1. Health-related quality of life of caregivers

    Quality of life score measured using the Singapore Caregiver Quality of Life Scale (SCQOLS), a 15-item quality of life measure covering 5 domains: physical well-being, mental well-being, experience \& meaning, impact on daily living, and financial well-being. The domain scores will be scaled to range from 0 to 100, with a higher score indicating better quality of life.

    Measured: 6th month.

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

    Longitudinal changes in quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal), across assessment timepoints. FACIT-Pal is 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.

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

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

    Longitudinal changes in quality of life score measured using the Singapore Caregiver Quality of Life Scale (SCQOLS), across assessment timepoints. SCQOLS is a 15-item quality of life measure covering 5 domains: physical well-being, mental well-being, experience \& meaning, impact on daily living, and financial well-being. The domain scores will be scaled to range from 0 to 100, with a higher score indicating better quality of life.

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

  4. Mood of patients with advanced cancer and their caregivers

    Mood measured using the Center for Epidemiological Studies-Depression (CES-D), a 20-item measure of symptoms clustered in 4 domains: depressed affect, somatic complaints, positive affect, and interpersonal activity. Scores will be scored to a total score ranging from 0 to 60, with higher scores indicating greater frequency of depressive experiences.

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

  5. Coping strategies of patients with advanced cancer and their caregivers

    Coping strategies measured using the Brief Coping Orientation to Problems Experienced (Brief-COPE) Inventory, a 28-item measure of coping strategies in 14 subscales: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioural disengagement, venting, positive reframing, planning, humour, acceptance, religion, and self-blame. This scale has been validated in the cancer population. Each subscale score will be derived from the sum of two corresponding items scored on a 4-point Likert scale from "I do not do this at all" to "I usually do this a lot".

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

  6. Palliative care concerns of patients with advanced cancer

    Palliative care concerns measured using the Integrated Palliative Care Outcomes Scale (IPOS), a brief measure of palliative care problems, covering physical and psychological symptoms, social and spiritual issues, communication, information needs, and practical concerns. The scores on all items will be summed to give a total score ranging from 0 to 40, with higher scores indicating more care needs.

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

  7. Health states of patients with advanced cancer

    Health states measured using the EuroQOL Group 5-Dimension Health-related Quality of Life Measurement (EQ-5D-5L), which contains a 5-item descriptive system measuring 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression; a visual analogue scale measuring overall health status.

    Measured: Baseline, every 3 months until death or end of the study.

  8. Healthcare resource utilization of patients with advanced cancer

    The following data will be extracted from electronic medical records: dates of emergency department visits and hospital admissions, hospital bill size, date of first review by existing palliative care services, date of death, and place of death.

    Measured: Baseline until death or end of the study.

  9. Caregivers' satisfaction with care

    Satisfaction with care measured using the Family Satisfaction with End-of-Life Care (FAMCARE) Scale, a 10-item unidimensional scale measuring family satisfaction. Scores on all items will be summed to give a total score ranging from 0 to 20, with higher scores indicating higher satisfaction levels.

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

  10. Healthcare resource utilization of caregivers

    Healthcare resource utilization and caregiving cost. A questionnaire recording employment status and productivity loss (hours missed from work, impairment while at work, and impairment in regular activities) due to caregiving. The following data will be extracted from electronic medical records: dates of emergency department visits and hospital admissions, and hospital bill size.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start26 Dec 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
715 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06044441
Sponsor's protocol ID
ENABLE-SG
Other IDs
HCSAINV23jan-0001
Acronym
ENABLE-SG
Status last verified
Apr 2026
First submitted
30 Aug 2023
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32023157
  • 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.

    PubMed 15130218
  • 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.

    PubMed 22573470
  • 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.

    PubMed 19690306
  • 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.

    PubMed 25800768
  • 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.

    PubMed 25800762
  • 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.

    PubMed 38287335

Questions about this trial

What is this clinical trial studying?

A study testing ENABLE-SG model in people with Neoplasms, run by National Cancer Centre, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grace M Yang, MRCP (+65 63065844, grace.yang.m.j@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life of patients with advanced cancer (time frame: 6th month.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06044441, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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