Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00633

2 Trial Registration Date

2018-11-09

i Registration Status

Prospective

3 Secondary IDs

2018.456

4 Source(s) of Funding

Departmental Seeding grant, CUHK

5 Primary Sponsor

The Nethersole School of Nursing, CUHK

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Vivian Wu

ii Address

Room 808, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

iii Phone

852 3943 1244

iv Email

vivianwu@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

China

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

i Name

Winnie KW So

ii Address

Room 731, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

iii Phone

39431072

iv Email

winnieso@cuhk.edu.hk

v Affiliation

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

vi Country

China

9 Official Scientific Title of the Study

The translation and psychometric testing of COmprehensive Score for financial Toxicity, Chinese version (COST-C)

10 Public Title

The translation and psychometric testing of COmprehensive Score for financial Toxicity, Chinese version (COST-C)

i Public Title in Chinese 研究名稱

翻譯財務毒性綜合評分量表為中文版及對癌症病人的信效度測試

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-10-02

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.456

14 Medical Condition Being Studied

Cancer

15 Intervention

i Types of intervention

Other

Please specify

It is not a clinical trial study

ii Description/ name of Intervention/article

Not applicable

iii Dosage form of the intervention

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

Not applicable

vi Frequency of the intervention

Not applicable

16 Comparative Treatments

i Description/ name of comparative treatments

Not applicable

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

(1) aged 18 years old or above, (2) being diagnosed with stage I - IV cancer, (3) receiving therapy for at least 2 months at the time for interview (4) being able to read Chinese or communicate in Cantonese.

ii Exclusion Criteria

Patients with cognitive impairment or language difficulties will be excluded.

iii Age Minimum

aged 18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-11-15

21 Target Sample Size

220

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

1. Socio-demographic characteristics, 2. Disease-related characteristics, 3. Financial Toxicity (COST)

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

1. Psychological distress (Distress Thermometer), and 2. Health related quality of life (FACT-G)

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-01-29

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-11-09