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Active Not RecruitingNCT07475312

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

SUPPORT+ Digital Self-Management and Clinical Support for Patients With Advanced Cancer in the Community: A Randomized Controlled Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
633 (actual)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSUPPORT+ Digital Symptom Monitoring and Clinical SupportSUPPORT+ 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.

Timeline

Start date
2023-01-16
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2026-03-16
Last updated
2026-04-02

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT07475312. Inclusion in this directory is not an endorsement.

SUPPORT+ Digital Self-Management and Clinical Support for Advanced Cancer (NCT07475312) · Clinical Trials Directory