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临床试验/NCT07475312
NCT07475312进行中(未招募)不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 633 人开始时间: 2023年1月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
633
试验地点
1
主要终点
Change in Health-Related Quality of Life

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

The statistician responsible for data analysis is masked to group allocation until completion of the primary analysis.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: SUPPORT+ Digital Symptom Monitoring and Clinical Support (Behavioral)

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.

结局指标

主要结局

Change in Health-Related Quality of Life

时间窗: Baseline to 18 weeks

Change in health-related quality of life measured using the EQ-5D-5L utility score. The EQ-5D-5L assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each is rated on five levels from 1 (no problem) to 5 (extreme problem). Utility scores range from -0.865 (worst health state) to 1 (perfect health) based on the Hong Kong value set. The EQ-VAS (0-100) captures self-rated health.

次要结局

  • Hospitalisations(Baseline to 18 weeks)
  • Completion of Advance Directives(Baseline to 18 weeks)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wing Lok Wendy Chan

Clinical Associate Professor

The University of Hong Kong

研究点 (1)

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