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

Neoplasms Clinical Trial

— ENABLE-SG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044441
• Other study ID #: ENABLE-SG
• Secondary ID: HCSAINV23jan-000
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2023
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: National Cancer Centre, Singapore
• Contact: Grace M Yang, MRCP
• Phone: +65 63065844
• Email: grace.yang.m.j[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 715
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• 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.

Other:
• 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

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability and adoption of ENABLE-SG among patients with advanced cancer and their caregivers.	An investigator-designed structured feedback survey on acceptability, relevance, comfort level, overall satisfaction, and intention to recommend ENABLE-SG to others in similar situations. All items are rated on a 5-point Likert scale.	At the end of study participation, up to the 12th month.
Other	Appropriateness and feasibility of ENABLE-SG among patients with advanced cancer, their caregivers, and healthcare providers	Semi-structured interviews conducted using an interview guide developed based on the Consolidated Framework for Implementation Research (CFIR).	=6 months after baseline.
Other	Fidelity of the delivery of ENABLE-SG	Fidelity to the health coaching protocol (intervention) will be assessed by a narrative synthesis of any modifications or deviations from the protocol. These modifications/ deviations will be extracted from self-reporting checklists, field notes, recordings of the actual health coaching sessions, and discussions of the completed health coaching sessions.	Through study completion, anticipated up to 3 years.
Other	Implementation cost	Process maps and project records detailing key intervention activities to elucidate cost of involved personnel and resources through a time-tracking system and an activity-based costing approach.	Through study completion, anticipated up to 3 years.
Other	Penetration	Based on study records, the Number and proportion of approached oncologists who agree for study to be conducted in their clinics.	Through study completion, an average of 2 years.
Primary	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	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.	6th month.
Secondary	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.	Baseline, 3rd month, 6th month, 9th month, 12th month.
Secondary	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.	Baseline, 3rd month, 6th month, 9th month, 12th month.
Secondary	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.	Baseline, 3rd month, 6th month, 9th month, 12th month.
Secondary	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".	Baseline, 3rd month, 6th month, 9th month, 12th month.
Secondary	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.	Baseline, 3rd month, 6th month, 9th month, 12th month.
Secondary	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.	Baseline, every 3 months until death or end of the study.
Secondary	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.	Baseline until death or end of the study.
Secondary	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.	Baseline, 3rd month, 6th month, 9th month, 12th month.
Secondary	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.	Baseline, 3rd month, 6th month, 9th month, 12th month.