Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00629

2 Trial Registration Date

2018-10-19

i Registration Status

Prospective

3 Secondary IDs

NA

4 Source(s) of Funding

Health and Medical Research Fund (HMRF) Research Fellowship

5 Primary Sponsor

Food and Health Bureau

6 Secondary Sponsor

Not applicable

Function

Not Applicable

Please specify

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

i Name

Cheung Yin Ting

ii Address

Rm 801, 8/F., Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

39436833

iv Email

yinting.cheung@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Yin Ting Cheung

ii Address

Rm 801, 8/F., Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

39436833

iv Email

yinting.cheung@cuhk.edu.hk

v Affiliation

School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Personalized Risk-based Care and Education for Early Survivors of Childhood Cancer in Hong Kong

10 Public Title

Risk-based Care and Education for Survivors of Childhood Cancer in Hong Kong

i Public Title in Chinese 研究名稱

為香港兒童癌症康復者提供風險護理教育和相關知識

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?

2018-09-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.338

14 Medical Condition Being Studied

Childhood cancer

15 Intervention

i Types of intervention

Other

Please specify

Not applicable

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

Diagnosed with cancer before the age of 18

At early phase of cancer survivorship, defined as 2 to 10 years post-therapy

Previously treated at a local medical institution in Hong Kong

Able to understand Cantonese and read Chinese

Currently residing in Hong Kong

*Patients under 18 years of age must be accompanied by a parent/guardian who (a) understands Cantonese and reads Chinese, and currently residing with and actively providing care for the patient

ii Exclusion Criteria

Cognitively incapable of providing informed consent

iii Age Minimum

999

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

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-11-05

21 Target Sample Size

250

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Health literacy and awareness of health risk

ii The metric or method of measurement used

Structured questionniares

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

Health behaviours and psychological distress

ii The metric or method of measurement used

Structured questionniares

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

2022-07-25

27 Primary Registry and Trial Identifying Number

ChiCTR1800019015

28 Date of Registration in Primary Registry

2018-10-19

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Trial History Detail on 2019-07-23