Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00508

2 Trial Registration Date

2016-04-18

i Registration Status

Prospective

3 Secondary IDs

2015.404-T

4 Source(s) of Funding

N/A

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Wenli Xiao

ii Address

Rm 806, ELB, CUHK, Shatin, N.T. Hong Kong

iii Phone

39439909

iv Email

allisonxiao@link.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

Wenli Xiao

ii Address

Rm 806, ELB, CUHK, Shatin, N.T. Hong Kong

iii Phone

39439909

iv Email

allisonxiao@link.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 feasibility and effectiveness of an educational intervention program on managing the nutrition impact symptom cluster in patients with nasopharyngeal carcinoma during radiotherapy

10 Public Title

The feasibility and effectiveness of an educational intervention program on managing the nutrition impact symptom cluster in patients with nasopharyngeal carcinoma during radiotherapy

i Public Title in Chinese 研究名稱

鼻咽癌放疗患者营养相关症状群健康教育干预项目的可行性及有效性研究

11 Short Title (Optional)

12 Countries of Recruitment

China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-09-16

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.404-T

14 Medical Condition Being Studied

nasopharyngeal carcinoma

15 Intervention

i Types of intervention

Other

Please specify

education

ii Description/ name of Intervention/article

an educational intervention program

iii Dosage form of the intervention

didactic education with demonstration and return demonstration

iv Dosage of the intervention

30 minutes

v Duration of the intervention

three weeks

vi Frequency of the intervention

two times

16 Comparative Treatments

i Description/ name of comparative treatments

usual care

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

first-treated Chinese patients with nasopharyngeal carcinoma

scheduled to receive RT

18 years old or above

able to communicate in Mandarin

ii Exclusion Criteria

Patients who have other serious diseases including diagnosed psychiatric morbidity and other types of cancer were excluded.

iii Age Minimum

18

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Block randomization with a block size of four was adopted.

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

nursing intervention

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-04-28

21 Target Sample Size

282

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

nutrition impact symptom cluster

ii The metric or method of measurement used

questionnaire

iii The timepoint(s) of primary interest

baseline; week 3 of RT; end of RT

24 Secondary Outcome

i The Name of the outcome

body weight

ii The metric or method of measurement used

kg

iii The timepoint(s) of primary interest

baseline; week 3 of RT; end of RT

Secondary Outcome

i The Name of the outcome

functional performance

ii The metric or method of measurement used

questionnaire

iii The timepoint(s) of primary interest

baseline; week 3 of RT; end of RT

Secondary Outcome

i The Name of the outcome

quality of life

ii The metric or method of measurement used

questionnaire

iii The timepoint(s) of primary interest

baseline; week 3 of RT; end of RT

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-09-02

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-04-18