Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00477

2 Trial Registration Date

2015-09-16

i Registration Status

Prospective

3 Secondary IDs

2014.153

KC/KE-14-0048/FR-1

4 Source(s) of Funding

Department of Paediatrics, CUHK, Association of Hong Kong Nursing Staff,

5 Primary Sponsor

nil

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Winnie Tang

ii Address

Room 806, 8/F, Esther Lee Building,
The Chinese University of Hong Kong,
Shatin, N. T.

iii Phone

3943 9904/9136 9486

iv Email

winnie.tang@cuhik.edu.hk

v Affiliation

PhD student

vi Country

Hong Kong

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

i Name

Yin Ping Doris Leung

ii Address

Room 830, 8/F, Esther Lee Building,
The Chinese University of Hong Kong,
Shatin, N. T.

iii Phone

3943 8172

iv Email

dorisleung@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

The impact of an-e-health intervention on stress, quality of life, and coping skills of parents of children with cancer: A multi-centered non-equivalent control group design

10 Public Title

The impact of an-e-health intervention on stress, quality of life, and coping skills of parents of children with cancer: A multi-centered non-equivalent control group design

i Public Title in Chinese 研究名稱

「香港兒童癌症病人的照顧者的網上心理教育」計劃對香港癌症兒科病人及家人的壓力及適應之效用

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?

2014-05-26

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

NTEC CREC: 2014.153, KEC CREC: KC/KE-14-0048/FR-1

14 Medical Condition Being Studied

pediatric cancer

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

E-health intervention, which include an informational website, online support group and a whatsapp group

iii Dosage form of the intervention

internet based

iv Dosage of the intervention

8 weeks

v Duration of the intervention

8 weeks

vi Frequency of the intervention

daily

16 Comparative Treatments

i Description/ name of comparative treatments

usual care and the link to the Children's Cancer Foundation website

ii Dosage form of the comparative treatments

depends on ward practice

iii Dosage of the comparative treatments

depends on ward practice

iv Duration of the comparative treatments

8 weeks

v Frequency of the comparative treatments

depends on ward practice

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Parents are eligible if they (1) age 18 years or above;

(2) weill be able or willing to access the internet or Whatsapp;

(3) able to understand Traditional Chinese

Patients are eligible for the study if they

(1) have been diagnosed with cancer regardless of the time being diagnosed;

(2) age under 19 yrears; and

(3) live with the parent in the same household

ii Exclusion Criteria

parents will be excluded if they are diagnosed with major psychiatric diseases

or patient is terminally ill

iii Age Minimum

18

iv Age Maximum

no limit

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

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

2015-09-23

21 Target Sample Size

100

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Stress

ii The metric or method of measurement used

perceived stress

iii The timepoint(s) of primary interest

baseline, 8 weeks, 12 weeks

24 Secondary Outcome

i The Name of the outcome

Coping

ii The metric or method of measurement used

Brief COPE and Kidscope

iii The timepoint(s) of primary interest

baseline, 8 weeks, 12 weeks

Secondary Outcome

i The Name of the outcome

Quality of Life

ii The metric or method of measurement used

Caregiver Quality of life index-Cancer (mandarin version), and The Generic Core Scales of the Paediatric quality of Life Inventory (PedsQLTM) 4.0 for child version or adolescent version

iii The timepoint(s) of primary interest

baseline, 8 weeks, 12 weeks

Secondary Outcome

i The Name of the outcome

Stress

ii The metric or method of measurement used

Saliva cortisol

iii The timepoint(s) of primary interest

baseline, 8 weeks, 12 weeks

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2015-09-16