SUPPORT+ Digital Self-Management and Clinical Support for Advanced Cancer

NCT07475312 | Active Not Recruiting

• 1 other identifier: CIRB-2023-011-3
• Study Type: interventional
• Target: 633
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether SUPPORT+, a digital symptom monitoring and self-management mobile application, can improve health-related quality of life and clinical outcomes in adults with advanced cancer receiving palliative care. The main questions this study aims to answer are:

• Does use of SUPPORT+ help maintain or improve health-related quality of life compared with usual palliative care?
• Does SUPPORT+ reduce functional decline and acute health care use, such as hospitalisations, compared with usual care? Researchers will compare patients using the SUPPORT+ mobile application with patients receiving usual palliative care to see if digital symptom monitoring combined with automated self-management guidance and nurse follow-up improves patient-reported and clinical outcomes. Participants assigned to the SUPPORT+ arm will:
• Use the SUPPORT+ mobile application for weekly symptom reporting using the Integrated Palliative Care Outcome Scale (IPOS)
• Receive automated self-management advice based on reported symptoms
• Receive follow-up contact from a nurse when severe or concerning symptoms are identified
• Continue to receive usual palliative care throughout the study period Participants assigned to the usual care arm will:
• Receive usual palliative care provided by their clinical team
• Complete study assessments at scheduled time points
• Not receive digital symptom monitoring, automated self-management advice, or nurse follow-up through the SUPPORT+ application

Conditions

Advanced Cancer; Palliative Care

Keywords

health related quality of life; hospitalisation; digital symptom monitoring; Palliative Care Outcome Scale (IPOS)

Outcome Measures

Primary Outcomes (2)

• Change in Health-Related Quality of Life (EQ-5D-5L index)

  Change in health-related quality of life measured using the EQ-5D-5L index (utility) score. The EQ-5D-5L assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels from 1 (no problems) to 5 (extreme problems). Utility scores are derived using the Hong Kong value set and range from -0.865 (worst health state) to 1 (perfect health).

  Baseline to 18 weeks

• Change in Self-rated health measured by EQ-VAS

  Change in self-rated health measured using the EQ-5D visual analogue scale (EQ-VAS), on which participants rate their overall health on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health).

  Baseline to 18 weeks

Secondary Outcomes (4)

• Change in Self-Efficacy for Managing Chronic Disease

  Baseline to 18 weeks

• Change in Eastern Cooperative Oncology Group (ECOG) Performance Status

  Baseline to 18 weeks

• Emergency Department Visits

  Baseline to 18 weeks

• Hospitalisations

  Baseline to 18 weeks

Other Outcomes (1)

• Advance care planning experience (including advance directive completion)

  Baseline to 18 weeks

Study Arms (2)

SUPPORT+ Plus Usual Palliative Care

EXPERIMENTAL

Participants in this arm receive usual palliative care supplemented by SUPPORT+, a mobile application providing weekly digital symptom monitoring, automated self-management guidance, and nurse follow-up for severe symptoms, for a duration of 18 weeks. After each submission, participants received symptom-specific self-management advice. Any report containing a severe symptom was transmitted in real time to palliative care nurses, who contacted patients within one working day during office hours to provide clinical support, including medication adjustments, self-management strategies, expedited appointments, or advice to attend the emergency department or admit to hospital. Participants could also contact nurses during office hours via the "Nurse Consult" feature; outside these hours, they were advised to seek urgent medical care.

Behavioral: SUPPORT+ Digital Symptom Monitoring and Clinical Support

Usual Palliative Care

NO INTERVENTION

Participants in this arm receive usual palliative care provided by their clinical team according to standard practice, without access to digital symptom monitoring, automated self-management guidance, or nurse follow-up through the SUPPORT+ application. They could access only the publicly available educational materials within the SUPPORT+ application.

Interventions

SUPPORT+ Digital Symptom Monitoring and Clinical Support BEHAVIORAL

SUPPORT+ is a mobile application that prompts participants to complete weekly symptom reporting using the Integrated Palliative Care Outcome Scale (IPOS). After each submission, the application provides automated, symptom-specific self-management advice. Reports indicating severe symptoms trigger real-time alerts to palliative care nurses, who contact participants during office hours to provide clinical guidance, including medication advice, self-management strategies, expedited clinic review, or recommendations for urgent medical care when appropriate. Participants may also initiate nurse contact through the application during office hours.

SUPPORT+ Plus Usual Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of advanced malignancy
• Decision not to pursue further systemic anticancer treatment
• Receiving follow-up care at a participating palliative care clinic
• Community-dwelling
• Ownership of a smartphone
• Adequate cognitive capacity to provide informed consent
• Willingness to receive notifications from the SUPPORT+ mobile application
• Presence of at least one symptom related to advanced cancer
• Ability for the patient or a designated primary caregiver to use the mobile application

You may not qualify if:

• Receiving systemic anticancer therapy with radical or palliative intent
• Estimated life expectancy of less than 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status greater than 3

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

1. Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR

Hong Kong, Hong Kong

Location

Study Officials

• Wing-Lok Wendy Chan, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician responsible for data analysis is masked to group allocation until completion of the primary analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: This study uses a parallel-group randomized controlled trial design. Eligible participants are randomly assigned in a 1:1 ratio to either the intervention arm (SUPPORT+ plus usual palliative care) or the control arm (usual palliative care alone). Participants remain in their assigned group for the duration of the 18-week study period. Outcomes are assessed at predefined time points and compared between groups to evaluate the effects of adding digital symptom monitoring with automated self-management guidance and nurse follow-up to usual palliative care.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: January 16, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)