SUPPORT+ Digital Self-Management and Clinical Support for Patients With Advanced Cancer in the Community: A Randomized Controlled Trial
Phase: NA
Conditions: Palliative Care, Advanced Cancer
Sponsor: The University of Hong Kong

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Protocol
 
–
 
Version 2
ClinicalTrials.gov Identifier:
NCT07475312
Study Protocol Title:
Use of mobile app 'SUPPORT+' to enhance community palliative care in advanced cancer
 
patients: a 
randomized controlled trial
Document Type:
Study Protocol
 
–
 
Version 2 (Amended)
Amendment Date:
14 June 2024
Principal Investigators:
Dr. Wendy Chan Wing Lok
Department of Clinical Oncology
The University of Hong Kong
Sponsor / Institution:
Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, The 
University of Hong Kong
Study Sites:
•
Queen Mary Hospital
•
Pamela Youde Nethersole Eastern Hospital
•
Princess Margaret Hospital
•
Queen Elizabeth Hospital
•
Tuen Mun Hospital
•
Haven of Hope Hospital
Description:
This is the amended study protocol incorporating updated methodology, revised statistical handling of
missing data, and refinements to study procedures for the SUPPORT+ digital symptom‑monitoring 
randomized controlled trial.

Study Proposal v.2 14.6.2024 
Use of mobile app “SUPPORT+” to enhance community palliative care in advanced cancer 
patients: a randomized controlled trial  
 
Contents 
1. Introduction 
P.1 
2. Aims and Hypotheses to be Tested 
P.3 
3. Plan of Investigation 
P.4 
4. Subjects (Sample Size Justification) 
- Inclusion criteria 
- Exclusion criteria 
- Sample size calculation 
P.5 
P.5 
P.5 
P.5 
5. Methods 
- Procedures:  
- Baseline assessment 
- Interventions 
- Outcome measures: Primary outcome (Health-related quality of life) 
- Outcome measures: Secondary outcomes 
   - Changes in performance status 
   - Frequency of emergency room (AED) visits 
   - Frequency and days of hospitalizations due to uncontrolled symptoms 
   - Self-efficacy 
- End of study assessment 
P.6 
P.6 
P.6 
P.7 
P.8 
P.9 
P.9 
P.9 
P.9 
P.9 
P.9 
6. Study Design 
P.10 
7. Data Processing and Analysis 
P.10 
 
 

Section: Research Project v.2 14.06.2024 
1 
 
 
 
Title:   
 
Use of mobile app “SUPPORT+” to enhance community palliative care in advanced cancer patients: 
a randomized controlled trial  
 
 
 
Introduction:  
 
Patients with advanced cancer often experience multiple physical and psychological symptoms 
because of progressing disease or anticancer treatment. A systematic review included 40 studies 
showed that patients with advanced cancer had a high prevalence of chronic symptoms.1 Over 50% 
of patients with advanced cancer experienced one of the following symptoms, including fatigue, pain, 
lack of energy, weakness, and loss of appetite. The top two symptoms experienced were fatigue 
(74%) and chronic pain (71%). Often, patients reported these symptoms only when they become 
severe. Moreover, patients with advanced cancer, especially in their last year of life, tend to have 
high utilisation of hospital services such as emergency room (AED) attendances and hospitalizations. 
Acute hospitalizations are always stressful to patients and their families if the goal of palliation is 
unmet and put major burden on the healthcare system.  
 
In Hong Kong, near 90% of the oncology services are provided by public cancer centres of the Hospital 
Authority, which is highly efficient but unfortunately, resources are tight. Palliative care is not just 
about end-of-life or in-patient hospice care.2 Most of the patients with advanced cancer, before their 
last period of time, are often ambulatory and taken care in the community. Both patients and their 
families wish to stay in the community as long as possible before admitted for hospice care. However, 
routine symptom monitoring for patients with cancer is not performed outside hospitals in Hong 
Kong. Symptoms usually happen in between clinic visits. There is hindrance for the health care team 
and the patients to effectively communicate about the uncontrolled symptoms, and the response of 
the health care team to symptom crisis is not fast enough. Unplanned admission or AED visit before 
scheduled clinic reassessment is common.3 Therefore, there is an urgent need for an efficient system 
to improve symptom monitoring and provide timely clinical support in advanced cancer patients in 
the community to alleviate their sufferings. 
 
Development of palliative care services has been regarded as one of the top priorities in the 
healthcare policy agenda worldwide, as well as locally in Hong Kong. According to the latest published 
“Hong Kong Cancer Strategy”, enhancing palliative care support for advanced cancer patients is one 
of the main missions.4 The Hospital Authority also published "Strategic Service Framework for 
Palliative Care" in 2017.5 It sets "enhance palliative care in the ambulatory and community settings 
to support patients and reduce unnecessary hospitalization" as one of the four main goals in 

Section: Research Project v.2 14.06.2024 
2 
palliative care in Hong Kong. It is important to provide ambulatory and community palliative care 
support to patients and their families/carers to facilitate care in place and reduce unnecessary 
hospitalization.  
 
Self-management is defined as ‘the person’s ability to manage the symptoms, treatment, physical 
and psychosocial consequences and lifestyle changes inherent in living with a chronic condition’.6 
Self-management has also been described as a participatory process where patients and clinicians 
develop strategies together to equip patients with the skills and knowledge to manage the impact of 
the condition, monitor their disease and make effective use of support services outside of the clinical 
setting.7 The ultimate goal is to enable and empower patients to achieve their own goals of care 
throughout the illness trajectory. 8  Self-management focuses five core skills including problem-
solving, decision making, resource utilisation, communication with health care professionals, and 
action planning or goal setting.9  
 
There is an increasing acceptance of integrating self-management into palliative care in cancer 
care.10,11 Their integration can support patients with advanced cancer and their family caregivers 
across the care trajectory positively. Previous reviews supported routine and timely use of self-
management strategies in palliative setting can reduce physical and psychological burden, improve 
physical functioning, enhance knowledge of care options, facilitate goal-setting and decision-making, 
maximize quality of life and reduce caregiver stress.12,13,14,15There are various delivery modes of self-
management interventions, including by nurses in person or by telephone, self-guided and eHealth, 
including web-based and mobile applications.16,17 Furthermore, eHealth interventions are increasing 
used in cancer management. It can enable patients to be actively engaged in healthcare, improve 
health outcomes, and lead to positive behavioural change.18,19 
 
Recently, systemic use of patient-reported outcome (PRO) measures, defined as the unfiltered and 
direct reporting of a given symptom by a patient without amendment or interpretation by a physician 
or anyone else, is considered as the gold standard for capturing symptoms or monitoring health-
related quality of life (HRQoL) in cancer patients.20 With greater internet connectivity and increasing 
availability of handheld and wearable electronic devices, electronic patient-reported outcomes 
(ePRO) have emerged as a feasible option for improving the quality of assessment, and they are 
expected to be an integral part of high-quality cancer care. Several ePRO systems have been 
developed and used in the oncology field in other countries.21 ,22 ,23 ,24 These ePRO systems can 
enhance patient care by flagging important symptoms, prompting clinicians to intensify symptoms 
management, and enhancing patient-clinician communication. A randomized controlled trial of a 
web-based symptom reporting system, by sending emails between nurses and patients who were on 

Section: Research Project v.2 14.06.2024 
3 
chemotherapy, compared with usual care performed in Memorial Sloan Kettering Cancer Centre 
(New York, USA) showed their PRO system helped improving quality of life, less hospitalization, less 
emergency room admission, longer overall survival (1 year survival: 75% vs. 69%, p=0.05) and longer 
quality-adjusted survival (mean: 8.7 vs. 8.0 months, p=0.004).25 Another multi-centre, randomized 
controlled trial on real time remote symptom monitoring in Europe (eSMART) demonstrated their 
system could reduce psychological distress and symptoms in patients with non-metastatic cancer 
who were on chemotherapy. 26  Besides using on patients receiving chemotherapy, a recently 
published systematic review on using ePRO system in palliative care demonstrated a few successful 
cases and revealed active studies on digital palliative cancer care interventions, highlighting 
significant room for research.27 
 
Hong Kong has one of the highest smart phone penetration rates in the World. Overall penetration 
rate was 92.1% in 2020.28 Even among elderly population (age >65), 68.1% owns a smartphone. 
Hence, using smartphone as a platform to facilitate symptom monitoring is potentially feasible. 
 
SUPPORT+ (“家支援”) is a mobile application initiative developed by the University of Hong Kong’s 
LKS Faculty of Medicine Department of Clinical Oncology. It was developed in collaboration with 
oncologists, palliative care specialists, nurses and community leaders to provide support for patients 
with advanced cancer and their caregivers or families to bring their care home. It was developed to 
support patients with advanced cancer to have an active role to self-manage their symptoms and 
improve their well-being. SUPPORT+ mobile app acts an additional support for cancer patients and 
their carers to help them equip their knowledge on cancer and palliative care, capture patients’ 
symptoms accurately and in real-time, and a step-care principle to deal with their symptoms by 
themselves with additional support from palliative care nurses. It aims to improve patients’ health-
related quality of life and self-confidence in managing their illness, avoid AED visits or 
hospitalizations, and enhance communication between patients/ carers with HCPs.  Details about 
SUPPORT+ app are in Appendix 1. More information about SUPPORT+ can be found in the link: 
https://support-plus.med.hku.hk/index.php?lang=TC 
 
This study will evaluate the benefits of the ePRO system SUPPORT+ for adults with advanced cancer 
through a carefully designed randomized controlled trial (RCT) that will be conducted in six oncology/ 
palliative care centres under the Hospital Authority. 
 
 
a) 
Aims and Hypotheses to be Tested: 
 
This is a multi-centre, randomized controlled trial. This trial aims to evaluate the potential benefits 
of a remote monitoring system SUPPORT+ in advanced cancer patients. The hypothesis is that 

Section: Research Project v.2 14.06.2024 
4 
addition of SUPPORT+ (weekly online symptom reporting for 18 weeks) to usual care would lead to  
improvement or less deterioration in HRQoL and performance status, better self-efficacy (self-care), 
reductions in symptom burden, AED visits and acute hospitalizations due to uncontrolled symptoms 
in advanced cancer patients in the community. 
 
Primary outcome: 
The main objective is to determine whether the addition of the ePRO system SUPPORT+ intervention 
can lead to improvement or maintenance in HRQoL compared with usual care. It is measured by the 
change in HRQoL from baseline to week 18, measured via the EQ-5D-5L. 29  The EQ-5D-5L 
questionnaire is a five-item general measure evaluating patients regarding the following dimensions: 
mobility, self-care, usual activities, pain/discomfort and anxiety/depression.  
 
Secondary outcomes: 
To evaluate the impacts of SUPPORT+ intervention compared with usual care, secondary outcomes 
include 
- 
Change in performance status (ECOG) from baseline to week 18 
- 
Frequency of emergency room visits 
- 
Frequency and days of hospitalizations due to uncontrolled symptoms 
- 
Symptom management (including both physical and emotional functioning) using 
Integrated Palliative Care Outcome Scale (IPOS) scale30 
- 
Self-efficacy, which is the patient’s confidence and ability to manage symptoms, measured 
by “Self-Efficacy for Managing Chronic Disease 6-Item Scale” 31,32 
 
 
 
 
b) Plan of Investigation: 
[For advanced medical research, please state clearly how the study will focus on clinical studies and 
apply advanced technologies to facilitate the translation of knowledge generated from health and 
health services or infectious diseases studies into clinical practice and to inform health policies.] 
 
[For study addressing thematic priorities under Implementation Science, please state clearly the 
proposed framework(s) / model(s) to be adopted and the pre-set criteria to evaluate/assess the 
barriers and facilitators of implementation outcomes.] 
 
[For Seed Grant application (i.e. grant ceiling is HK$500,000), please state clearly the pre-set criteria 
to enable scale-up to a larger project and/or enhance the efficacy/effectiveness of existing practice.] 
 

Section: Research Project v.2 14.06.2024 
5 
This study is a multi-centre, 1:1 allocation prospective randomised two-arm parallel group design. 
Participants will be randomised to two groups: the intervention group (SUPPORT+ plus usual care) or 
the control group (usual care). Participants will include advanced cancer patients who have follow-
up in palliative care clinic in the Department of Clinical Oncology at Queen Mary Hospital, Pamela 
Youde Nethersole Eastern Hospital, Princess Margaret Hospital, Queen Elizabeth Hospital, Tuen Mun 
Hospital and the Division of Palliative Medicine at Tuen Mun Hospital.  
 
 
(i)  Subjects (with justification on the sample size)  
 
 
Inclusion criteria: 
1. 
Aged >18 years old at time of consent 
2. 
A diagnosis of advanced malignancy (inoperable) 
3. 
Follow-up in palliative care clinic in Department of Clinical Oncology at Queen Mary 
Hospital, Pamela Youde Nethersole Eastern Hospital, Princess Margaret Hospital, Queen 
Elizabeth Hospital, Tuen Mun Hospital and the Division of Palliative Medicine at Tuen Mun 
Hospital 
4. 
Smartphone owners  
5. 
Taken care in the community  
6. 
No severe cognitive dysfunction 
7. 
Agree to receive notifications from the SUPPORT+ app on their smartphone  
8. 
Suffer from at least one symptom related to their advanced cancer 
9. 
Valid consent is obtained with permission to review their medical records 
 
Exclusion criteria: 
1. 
Those on treatment for their cancer in radical intent 
2. 
Short life expectancy of less than 3 months (ECOG > 3) 
 
Sample size calculation:  
The primary endpoint is the change in EQ-5D-5L score from baseline to week 18. Comparison 
on the changes of the score between the two groups: intervention group (SUPPORT+ added on 
usual care) and the usual care group. The hypothesis is that the SUPPORT+ group will 
significantly surpass the usual care group in terms of the HRQoL changes from baseline to week 
18. In order words, the HRQoL will either be improved or deteriorated less in the intervention 
group compared with that of the usual care group.  
 
Taking the EQ-5D minimal important difference (MID) estimate of 0.11 for advanced cancer and 
standard deviation of 0.2, sample size of 157 per group will be necessary to achieve 90% power 

Section: Research Project v.2 14.06.2024 
6 
to detect difference of greater than MID at 5% signature.33 Assuming around 20% dropout rate, 
enrolment of 394 participants is planned. The sample size calculation also accounts for the 
stratification (see Methods). 
 
 
(ii)  Methods  
 
 
Patients with advanced cancer having follow-up in palliative care clinic are enrolled in a 
prospective, randomized two-arm parallel group study over 18 weeks.  
 
Physicians from each centre will identify the eligible patients. The research assistant will then 
approach the eligible patients in the waiting area after consultation. After explanation of the 
study and participant’s rights, eligible patients will sign the consent form. Consenting patients 
are randomly assigned 1:1 to two groups: intervention group (SUPPORT+ added to usual care) 
or usual care group, stratified by (1) aged >65 years vs. <65 years; (2) patients with chronic pain 
on opioids vs. not on opioids in random permuted blocks (variable block sizes: 8, 10, 15); (3) 
app user (patient vs. caregiver). Stratification is used in the randomization process, as we expect 
age and use of opioids have major influences on our study outcomes. According to the Hong 
Kong Cancer Register, around 50% of the cancer patients were diagnosed at age > 65. from the 
literature, around 53% of cancer patients had chronic pain that required long-term opioids. 
Since older adults have different physical functions and have different social background 
compared with the younger adults, as well as they are usually not so tech-friendly and may need 
carers support in using the app, we stratify aged > 65 years old during randomisation. For 
patients who use opioids, they usually have more severe symptoms and may have more 
psychological stress. 
 
Random assignment of clinicians is not possible because of the established team structures; 
therefore, staff saw patients in both arms.  
 
Procedures 
Baseline assessment 
After signing consent, baseline information of each participant including age, gender, social 
background (marital status, occupation, and educational level), co-morbid conditions, baseline 
performance status, type of cancer and sites of metastasis, primary carer, medications used, 
average number of hospital admission in the past three months, number of AED visits in the 
past 3 months, experience and knowledge on palliative care, and health literacy will be collected 
at the initial visit. The SUPPORT+ app will be installed on the patient’s smartphone. Android 
based and IOS based apps are both available. 

Section: Research Project v.2 14.06.2024 
7 
 
Interventions 
(A) Usual care group 
Patients with advanced cancer have medical consultations in palliative care clinic and discuss on 
their care plan with symptom control. During follow-up, patients are regularly assessed by 
palliative care physicians for any symptoms and medications are prescribed till next clinic visit. 
Patients can use the SUPPORT+ app to read the educational materials only. The educational 
materials are the same as in the app for public to download. 
 
(B) Intervention group (SUPPORT+ added on usual care) 
Participants in the intervention arm also receive same care as the usual care group. In addition, 
they can use the full function of the app. They need to report their symptoms weekly and can 
contact their palliative care nurses directly on the app during the 18-week study period. The 
app interface is designed to collect the common symptoms according to the Integrated Palliative 
care Outcome Scale (IPOS).30 The IPOS is a brief measure of palliative care problems and 
assessment of patient’s QoL. It has proven to be an important and relevant tool in improving 
the practice of palliative care (See Appendix 2). The IPOS a valid and reliable outcome measure, 
both in patient self-report, carer-report and staff proxy-report versions, allowing maximum 
flexibility for clinical use. It has ten questions (17 items) which assess the following dimensions 
in advanced illness: physical, emotional, psychological, spiritual and provision of information 
and support. Five response options (score 0-4) are provided for each question, and only one 
response is allowed. An item scored 3 means severe and scored 4 means overwhelmingly. 
 
Every week, an email or app-alert will be sent to the participants to record their symptoms on 
the mobile app. After reporting the weekly symptom diary on the SUPPORT+ app, participants 
will receive links on self-management according to their reported symptoms. The symptom 
record will also be sent to the palliative care nurse at real time. When reported symptom score 
reaches 3 or above, oncology or palliative care nurses will be alerted. During office hours, nurses 
will contact the participants and see what actions to take in response to the alerts within one 
working day. The medical advice includes adjustment on medication, tips on self-management, 
advancing medical appointments, referring to AED or hospitalization, etc. During non-office 
hours, patients are encouraged to seek for medical opinion in cases of emergency. A report 
tracking participants' symptoms will be reviewed by the attending oncologist/ palliative care 
physician at each clinic visit.  
 
Besides reporting on the weekly symptom diary, participants can use the “Consult Nurse” in the 

Section: Research Project v.2 14.06.2024 
8 
mobile app to communicate with the palliative care nurses during office hour.  
 
Both groups can continue to use the SUPPORT+ mobile app after the 18-week study period. 
The management flow of the two groups is summarised is Figure 1. 
 
Outcome measures: 
All participants have assessment at three time-points: baseline assessment (week 0), week 9, 
and week 18. During each time point, participants will meet our research coordinator and 
complete a questionnaire on HRQoL, self-efficacy and ECOG performance status. Assessment 
will also be done by our research coordinator on performance scale, experience on advanced 
care planning, AED visits and hospitalizations. 
 
Primary outcome: 
(1) Health-related quality of life (HRQoL) 
The primary outcome is the change in HRQoL measured by EQ-5D-5L utility score.29 The EQ-
5D-5L questionnaire is a reliable, validated and preferred measure of HRQoL in patients with 
advanced cancer.34,35,36,37,38 It measures five dimensions (mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression) with five levels each. It produces a EQ-5D-5L 
utility score between -0.865 (for the worst possible health state) and 1 (for the perfect 
health state), based on Hong Kong EQ-5D-5L value set.39 Lower scores represent worse 
HRQoL. The EQ-VAS is also used to measure self-rated health. It is a vertical 100-point 
response scale, from 0 (worst health you can image) to 100 (best health you can image). 
This scale has been validated in advanced cancer patients with reliability of 0.75-0.89.40,41,42 
A cumulative effect of the intervention was anticipated, and hence, a timepoint of 18 weeks 
(end of study) is selected as the primary endpoint, with 9 weeks being secondary endpoint. 
 
Extensive research has shown EQ-5D-5L to be valid, reliable, and responsive in a wide range 
of conditions and populations, including patients with advanced cancer.43 44 There are 
systematic reviews demonstrating the validity and reliability of EQ-5D-5L in measuring 
HRQoL in patients with cancer. Moreover, EQ-ED-5L is frequently used in different oncology 
studies to measure HRQoL. According to the National Institute for Health and Care 
Excellence (NICE) guidelines, the EQ-5D is a recommended tool for estimating quality-
adjusted life years (QALYs) using utility values for evaluating cost-effectiveness analyses of 
the intervention programs.45 
  
 

Section: Research Project v.2 14.06.2024 
9 
Secondary outcomes: 
(1) Changes in performance status  
The performance status is measured by Eastern Cooperative Oncology Group (ECOG) 
performance status (PS) scale. This is a widely used scale to assess the functional status and 
self-care of a patient. ECOG PS scale uses 5 points score (0 denoting perfect health and 5 
death) to assess PS and is considered simple tool to use in daily clinical practice.46  
 
(2) Frequency of emergency room (AED) visits 
The total number of AED visits during the study period can be counted by reviewing the 
medical records in the Clinical Management System (CMS) under Hospital Authority. 
Reasons of AED visit are recorded and analysed. 
 
(3) Frequency and days of hospitalizations due to uncontrolled symptoms 
The total number of admissions and total number of days of hospitalizations during the 
study period can be counted by reviewing the medical records. Reasons of hospitalizations 
are recorded and analysed. 
 
(4) Self-efficacy 
Self-efficacy is the confidence level that the patient can manage his own symptoms. It is 
measured by “Self-Efficacy for Managing Chronic Disease 6-Item Scale”, which is a validated, 
brief and effective tool that directly measures the self-efficacy for chronic diseases.31,32 This 
6-item scale covers domains that are common across many chronic diseases such as 
symptom control, role function, emotional function and communication with physicians. 
Each item is rated on a 1 ‘not at all confident’ to 10 ‘totally confident’ scale. The score is the 
mean of the items, with the score range 1–10. A higher score indicates higher self-efficacy 
or more confidence in managing chronic disease. The change in self-efficacy from baseline 
to end-of-study (Week 18) is measured. This tool was translated into different languages 
including Chinese. The Chinese version was validated and published in 2013, with good 
reproducibility (ICC = 0.78; 95% CI, 0.70–0.84), and the reliability was good (Cronbach’s 
alpha = 0.88).32 
 
End of study assessment (week 18) 
At the end of the study (Week 18), patients will have the end-of-study assessment. Assessment 
includes HRQoL, ECOG performance status and self-efficacy for managing chronic disease. The 
frequency of AED visits in the past 3 months, hospitalisations (frequency and number of days in 
the past 3 months) will be reviewed in the Computer Medical Record of the participants.  

Section: Research Project v.2 14.06.2024 
10 
 
 
 
(iii) Study design  
 
 
This is a multi-centre, 1:1 allocation prospective randomised controlled trial with two-arm 
parallel group design. 
 
 
(iv) Data processing and analysis  
 
 Clinical and patient demographics are investigated by descriptive analyses for the entire study 
population. Categorical variables are calculated in counts and percentages while continuous 
variables are calculated by means and standard deviations.   
 
For the analysis of primary outcome, EQ-5D-5L utility scores for participants in each study arm 
are calculated at 18 weeks and compared with baseline scores, excluding those who have not 
completed any postbaseline EQ-5D questionnaire. The proportion of patients in each arm who 
experience improved and non-improved scores from baseline to end-of-study are compared 
using Fisher’s exact test. Mean score changes of EQ-5D-5L utility scores and EQ-VAS scores from 
baseline to end-of-study are compared using independent t-test. A multivariable linear 
regression model is performed with change of EQ-5D-5L utility score and EQ-VAS score as the 
dependent variable. Mean score changes of symptom management scores, self-efficacy scores, 
and knowledge on palliative care scores from baseline to end-of-study are compared.  
 
Separate multivariable linear regression models are performed with the changes of ECOG PS, 
symptom management scores (IPOS) and self-efficacy score from baseline to end-of-study 
follow-up as dependent variables. 
 
For AED visits and hospitalizations due to uncontrolled symptoms, cumulative incidence 
functions are calculated with death treated as a competing event. Competing risk regression is 
used to model treatment effects.  
 
Given the clinical context of advanced cancer, a substantial proportion of missing outcome data 
arises from patient deterioration and death before the week‑18 assessment. Because 
health‑related quality of life (HRQoL) can only be measured while a patient is alive, HRQoL 
outcomes cannot be validly imputed for participants who die during the study period. As this 
pattern of missingness is non‑ignorable and not amenable to standard imputation approaches, 
the primary analysis will be conducted on a complete dataset, defined as participants who have 
completed HRQoL assessments at baseline, week 9, and week 18. This approach ensures that 

Section: Research Project v.2 14.06.2024 
11 
HRQoL outcomes reflect true patient‑reported data rather than assumptions about 
unobservable states after death. Two‑sided P‑values <0.05 will be considered statistically 
significant. 
 
To account for the subject heterogeneity, subgroup analysis, including age (<65 vs. > 65 years 
old) and whether use of opioid, will be performed. We will also test the heterogeneity of effect 
size across subgroups using p-interaction. 
 
Analyses will be performed by using SPSS / R software. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Use of mobile app “SUPPORT+” to enhance community palliative care in advanced cancer patients: 
a randomized controlled trial 
 
Background 
 
Cancer is one of the most prevalent non-communicable diseases in Hong Kong due to the growing 
aging population. Cancer incidence in Hong Kong has increased by about 35% compared to a decade 
earlier, at an average rate of 3.1% per annum.1  The annual number of new cancer cases in Hong Kong 
hit a historical high of 35,082 in 2016 and it is projected to increase by approximately 35% to over 
42,000 by 2030. Cancer is also the leading cause of death in Hong Kong. It accounted for more than 
30% of all deaths. Over the past decade, the number of cancer deaths rose at an average rate of 1.5% 
per year. 
 
Patients approaching end of life, especially in their last year of life, tend to have high utilisation of 
hospital services such as emergency room attendances and hospitalizations. Acute hospitalizations 
are not only a stressor to patients and their families/ carers if the goal of palliation is unmet, but puts 
a major burden on the healthcare system. 
 
Development of palliative care services has been regarded as one of the top priorities in the healthcare 
policy agenda worldwide, as well as locally in Hong Kong. According to the latest published “Hong 
Kong Cancer Strategy”, enhancing palliative care support for cancer patients approaching end-of-life 
is one of the main missions.2 It emphasizes on the urge of collaboration among different specialties 
along the care continuum from hospital to community setting to facilitate care in the place. The 
Hospital Authority also published "Strategic Service Framework for Palliative Care" in 2017.3 It sets 
"enhance palliative care in the ambulatory and community settings to support patients and reduce 
unnecessary hospitalization" as one of the four main goals in palliative care in Hong Kong. It is 
important to provide ambulatory and community palliative care support to patients and their families/ 
carers to facilitate care in place and reduce unnecessary hospitalization. The emphasis is on enhancing 
day care, home care, support to residential care homes, and community partnership. 
 
Moreover, in the “Government policy measures to promote smart elderly care services” published in 
2017, development of gerontechnology, combination of elderly services and innovate technology, is 
noted to be of utmost importance in order to improve quality of life of elderlies and enhance their 
social function. The use of communication technologies can facilitate contact between elderlies and 
families/ carers and health care professionals, thereby strengthening the social connection of the 
elderlies. 
 
 
 
 
 
Appendix 1

 
 
Introduction to SUPPORT+  
SUPPORT+ mobile application is a mobile application initiative developed by the University of Hong 
Kong’s LKS Faculty of Medicine Department of Clinical Oncology. It is developed in collaboration with 
oncologists, palliative care specialists, nurses and community leaders to provide support for patients 
with advanced cancer and their caregivers or families to bring their care home. It was developed to 
support patients with advanced cancer to have an active role to self-manage their symptoms and 
improve their well-being. SUPPORT+ mobile app acts an additional support for cancer patients and 
their carers to help them equip their knowledge on cancer and palliative care, symptom monitoring 
and a step-care principle to deal with their symptoms by themselves with additional support from 
palliative care nurses. (This is to supplement Appendix 1: SUPPORT+ Information sheet) 
The website of SUPPORT+: https://support-plus.med.hku.hk/index.php?lang=TC 
SUPPORT+ App download link: https://onelink.to/be45gq 
 
SUPPORT+ has three main modules: 
1. Equip Yourself: Education Materials 
All users (both control group and intervention group) can access educational materials related to 
cancer information, palliative care and end-of-life care to elevate their knowledge on palliative care. 
This information can be accessed both via the mobile app or the web platform.  
Importantly, there are educational materials on end-of-life care and advance care planning. 
Information on end-of-life planning including will setting, burial, bereavement care, legal procedures 
and regulations related to "dying-in-place" will also be provided. If patients or families have wishes to 
"dying-in-place", they can also contact palliative care nurses through the apps for nurse consultation. 
Information about advance care planning (ACP), advance directive (AD), "Do not attempt 
cardiopulmonary resuscitation” (DNACPR), will setting, public and private hospices are available for 
patients or caregivers to follow step-by-step. 
2. Symptom Diary 
The symptom diary is a monitoring tool of the patient’s symptoms to ensure that any changes to the 
patient’s physical or mental wellbeing are being monitored closely and can be addressed promptly. It 
also allows for tracking of the symptoms over periods of time to monitor any potential deterioration 
to the patient’s condition.  
Every week, an in-app notification will be sent to remind the patients in the intervention group to 
record their symptoms on the mobile app. They need to answer a series of questions in relation to 
their physical health, pain score and mental wellbeing. The questions were developed based on the 
Integrated Palliative care Outcome Scale (IPOS). IPOS includes both physical symptoms and 
psychological concerns commonly experienced by cancer patients. Questions on physical symptoms 
and mental wellbeing are scored from 0 to 4 and pain score is scored from 1-10.  
After the patients answer the weekly symptom diary, the system will respond and give self-
management advice and words of encouragement to the patients according to their reported 
symptoms. For example, if patient reports “nausea and vomiting”, the system will give advice to 
patient on how to manage this discomfort. Moreover, when the patients report symptoms scored 3 

 
or above, palliative care nurses will contact the patients within one office day during working hours 
and advise on what actions the patients need to take.  
3. Contact Nurse 
The “Contact Nurse” function is an instant messaging function that enables for text messages, voice 
messages and photos to be sent between patients/caregivers and their designated nurses during 
office hours to seek assistance. This function works in conjunction with the symptom diary to provide 
a way for patients to promptly notify their healthcare team of any changes to their condition so that 
it can be addressed rapidly. 
In our study, the control group can access the first function (Educational materials) while the 
intervention group can use all three functions. 
 
 
 
 
 
 
 
 

 
Below are illustrations of the mobile application to demonstrate the overall workflow and features:  
Homepage 
 
 
1. Equip yourself: educational materials 
 

 
 
2. Symptom Diary 
 
 
 

 
 
3. Contact Nurse 
 
 
 
 
1 Hong Kong Cancer Registry Overview of HK Cancer Stat 2019.pdf (ha.org.hk) 
2 Hong Kong Cancer Strategy 2019, available at https://www.chp.gov.hk/files/pdf/aw_report_web.pdf 
 
3 Strategic Service Framework for Palliative Care" available at 
https://www.ha.org.hk/haho/ho/ap/PCSSF_1.pdf 
 
 

 
 
 
 
    
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
Slightly 
Moderately 
Severely 
 
 
Over-
whelmingly 
 
Pain 
0 
1 
2 
3 
4 
Shortness of breath 
0 
1 
2 
3 
4 
Weakness or lack of energy 
0 
1 
2 
3 
4 
Nausea (feeling like you are 
going to be sick) 
0 
1 
2 
3 
4 
Vomiting (being sick) 
0 
1 
2 
3 
4 
Poor appetite 
0 
1 
2 
3 
4 
Constipation 
0 
1 
2 
3 
4 
Sore or dry mouth 
0 
1 
2 
3 
4 
Drowsiness 
0 
1 
2 
3 
4 
Poor mobility 
0 
1 
2 
3 
4 
Please list any other symptoms not mentioned above, and tick one box to show how they have 
affected you over the past week. 
1. 
0 
1 
2 
3 
4 
2. 
0 
1 
2 
3 
4 
3. 
0 
1 
2 
3 
4 
 
 
Use of mobile app “SUPPORT+” to enhance community palliative care in advanced cancer patients: a 
randomized controlled trial
IPOS Questionnaire
Department of Clinical Oncology, The University of Hong Kong
IPOS Patient Version
 
(Week 0, 9, 18)
 
–
 
in app questionnaire
Q1. What have been your main problems or concerns
 
over the past week?
1. ............................................................................................................................................
2. ............................................................................................................................................
3. ............................................................................................................................................
Q2. Below is a list of symptoms, which you may or may not have experienced.
 
For each symptom,
please tick
 
one box
 
that best describes how it has
 
affected
 
you
 
over the past week.
Appendix 2

 
 
 
 
    
11 
 
Over the past week: 
 
Not at all 
Occasionally Sometimes 
Most of the 
time 
Always 
Q3. Have you been feeling 
anxious or worried about your 
illness or treatment? 
0 
1 
2 
3 
4 
Q4. Have any of your family or 
friends been anxious or 
worried about you? 
0 
1 
2 
3 
4 
Q5. Have you been feeling 
depressed? 
0 
1 
2 
3 
4 
 
 
Always 
Most of the 
time 
Sometimes 
Occasionally 
Not at all 
Q6. Have you felt at peace? 
0 
1 
2 
3 
4 
Q7. Have you been able to 
share how you are feeling with 
your family or friends as much 
as you wanted? 
0 
1 
2 
3 
4 
Q8. Have you had as much 
information as you wanted? 
0 
1 
2 
3 
4 
 
Problems 
addressed
/ No 
problems 
Problems 
mostly 
addressed 
Problems 
partly 
addressed 
Problems 
hardly 
addressed 
Problems 
not 
addressed 
Q9. Have any practical 
problems resulting from your 
illness been addressed? (such 
as financial or personal) 
0 
1 
2 
3 
4 
 
On my own 
With help from a 
friend or relative 
With help from a 
member of staff 
Q10. How did you complete 
this questionnaire? 
 
 
 
 
If you are worried about any of the issues raised on this questionnaire, then please speak to your 
doctor or nurse.                                                   --- END --- 
Use of mobile app “SUPPORT+” to enhance community palliative care in advanced cancer patients: a
randomized controlled trial
IPOS Questionnaire
Department of Clinical Oncology, The University of Hong Kong