Advanced Cancer, Palliative Care
Conditions
Keywords
health related quality of life, hospitalisation, digital symptom monitoring, Palliative Care Outcome Scale (IPOS)
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
Detailed description
Patients with advanced cancer often experience substantial physical and psychological symptom burden that negatively affects health-related quality of life and may lead to avoidable emergency department visits and hospitalisations. Digital symptom monitoring tools may support earlier identification of symptom deterioration and timely intervention, but evidence in palliative care populations remains limited. This multicentre, randomised controlled trial evaluated whether adding SUPPORT+, a mobile application for symptom monitoring with automated self-management guidance and nurse follow-up, to usual palliative care could improve patient-reported outcomes and healthcare utilisation among adults with advanced cancer. Community-dwelling adults aged 18 years or older with advanced malignancy who had decided not to pursue further systemic anticancer treatment and were receiving follow-up at palliative care clinics in six public hospitals in Hong Kong were recruited. Eligible participants were required to own a smartphone, have adequate cognitive capacity to provide informed consent, be willing to receive application notifications, and report at least one symptom related to advanced cancer. Patients with an estimated life expectancy of less than three months or an Eastern Cooperative Oncology Group (ECOG) performance status greater than 3 were excluded. Caregivers were permitted to act as proxy users when participants were unable to use the application independently. Participants were randomly assigned in a 1:1 ratio to either the intervention group (SUPPORT+ plus usual care) or the usual care group. Randomisation was stratified by age, chronic opioid use, and app user (patient or caregiver proxy). Clinicians providing routine palliative care were not informed of group allocation. All participants received standard palliative care according to usual clinical practice. Participants in the intervention group additionally received full access to the SUPPORT+ mobile application for 18 weeks. Weekly notifications prompted symptom reporting using the Integrated Palliative Care Outcome Scale (IPOS). Following each submission, participants received automated symptom-specific self-management advice. Reports containing any severe symptom triggered real-time alerts to palliative care nurses, who contacted participants during office hours to provide clinical guidance, including medication advice, self-management strategies, expedited clinic review, or recommendations for urgent care when appropriate. Participants could also initiate nurse contact through the application during office hours. Assessments were conducted at baseline, week 9, and week 18. The primary outcome was change in health-related quality of life measured using the EQ-5D-5L utility score. Secondary outcomes included self-rated health (EQ-VAS), self-efficacy for managing chronic disease, ECOG performance status, emergency department visits, hospitalisations, length of hospital stay, and completion of advance directives. Healthcare utilisation data were retrieved from electronic medical records.
Interventions
BEHAVIORALSUPPORT+ Digital Symptom Monitoring and Clinical Support
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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
The statistician responsible for data analysis is masked to group allocation until completion of the primary analysis.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life (EQ-5D-5L index) | Baseline to 18 weeks | 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). |
| Change in Self-rated health measured by EQ-VAS | Baseline to 18 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Efficacy for Managing Chronic Disease | Baseline to 18 weeks | Change in self-efficacy measured using the 6-item Self-Efficacy for Managing Chronic Disease Scale (SEMCD-6S). The SEMCD-6S assesses an individual's confidence in managing symptoms and the impact of a chronic condition on daily life, including fatigue, pain, emotional distress, symptom control, and self-management activities. Each item is rated on a numeric scale from 1 (not at all confident) to 10 (totally confident). The overall score is calculated as the mean of the six items, with higher scores indicating greater self-efficacy. |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline to 18 weeks | Change in functional status measured using the Eastern Cooperative Oncology Group (ECOG) Performance Status scale. The ECOG scale is a clinician-rated measure of a patient's level of functioning and ability to perform daily activities, ranging from 0 to 4, with lower scores indicating better functional status. Scores are defined as follows: 0 = fully active with no restrictions; 1 = restricted in physically strenuous activity but ambulatory and able to perform light work; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care and confined to bed or chair more than 50% of waking hours; 4 = completely disabled and unable to perform any self-care. |
| Emergency Department Visits | Baseline to 18 weeks | Number of emergency department visits recorded in electronic medical records. |
| Hospitalisations | Baseline to 18 weeks | Number of hospital admissions and total length of hospital stay recorded in electronic medical records. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORWing-Lok Wendy Chan, MBBS
The University of Hong Kong
Outcome results
None listed