Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00589

2 Trial Registration Date

2018-03-08

i Registration Status

Prospective

3 Secondary IDs

2017.517

4 Source(s) of Funding

The Nethersole School of Nursing

5 Primary Sponsor

The Nethersole School of Nurisng

6 Secondary Sponsor

No

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Vivian Wu

ii Address

Room 808, 8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, New Territories

iii Phone

39431244

iv Email

vivianwu@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Fiona Tang

ii Address

Room 624, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, New Territories

iii Phone

39434235

iv Email

wktang@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Tailored Self-Management of Symptoms Supported by a Mobile App for Lung Cancer Patients: A Randomised Controlled Study

10 Public Title

Tailored Self-Management of Symptoms Supported by a Mobile App for Lung Cancer Patients: A Randomised Controlled Study

i Public Title in Chinese 研究名稱

應用程式輔助個人化自我症狀管理的隨機對照研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-02-14

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

217.517

14 Medical Condition Being Studied

Lung cancer

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

A mobile app for lung cancer patients to self-manage individual symptoms

iii Dosage form of the intervention

Tablet PC

iv Dosage of the intervention

Once per week

v Duration of the intervention

4 Weeks

vi Frequency of the intervention

Everyday

16 Comparative Treatments

i Description/ name of comparative treatments

Usual care

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Not applicable

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

aged 18 or above

have been diagnosed with lung cancer within the last year

are able to read Chinese and communicate in Cantonese

display no cognitive impairment (with an Abbreviated Mental Test score of 8 or above)

have good performance status (with a Karnofsky score of 60% or above)

consent to participate in the study

ii Exclusion Criteria

with a documented psychiatric condition

iii Age Minimum

18

iv Age Maximum

99

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

A sequence of grouping identifiers (I or C), based on computer-generated random codes

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-03-26

21 Target Sample Size

144

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

symptom distress

ii The metric or method of measurement used

Survey

iii The timepoint(s) of primary interest

Week 0 and Week 4

24 Secondary Outcome

i The Name of the outcome

levels of cytokines

ii The metric or method of measurement used

Blood specimen

iii The timepoint(s) of primary interest

Week 0 and Week 4

Secondary Outcome

i The Name of the outcome

Health-related quality of life

ii The metric or method of measurement used

Survey

iii The timepoint(s) of primary interest

Week 0 and Week 4

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-04-03

27 Primary Registry and Trial Identifying Number

ChiCTR1800015145

28 Date of Registration in Primary Registry

2018-03-10

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Trial History Detail on 2018-03-22