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Trial registered on ANZCTR

Registration number

ACTRN12614000668606

Ethics application status

Approved

Date submitted

13/06/2014

Date registered

25/06/2014

Date last updated

25/07/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluation of patient decision aid for Localized Prostate cancer patients in Referral hospitals in peninsular Malaysia.

Scientific title

Effect of a patient decision aid booklet on knowledge, decisional conflict, and satisfaction with preparation for decision making ,with localised prostate cancer patients in referral hospitals in Peninsular Malaysia

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1157-9380

Trial acronym

PDA LPC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate Cancer (Stage 1 and stage 2)

Condition category

Condition code

Cancer

Prostate

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patient Decision Aid Booklet provide guide for treatment option for localized prostate cancer patient,the treatment option stated in the booklet are watchful waiting,active surveillance,radiotherapy and surgery,
radiation therapy and surgery option that available in Malaysia.
Each of treatment option,describe on the procedures will be implement by doctor,the advantages and disadvantages and other issues that should patient concern about.
Patient will be given the booklet after consultation with the doctor who will discuss about the treatment options, after the patient consultation with doctor, researcher will briefly explain to the patient about the booklet after the consultation session. Then patient will bring the booklet home for further reading and discuss with their family.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Following standard usual care means that the patient will only received consultation with the doctor who will discuss about the treatment options verbally. Patient will not be given the decision aid booklet after consultation.

Control group

Active

Outcomes

Primary outcome [1]

Knowledge assessed by validated Prostate cancer Knowledge questionnaire

Timepoint [1]

Randomization is done by random block by week. Patients will be randomized to either intervention or control according to the weeks they come for follow up.
For each control and intervention group,assessment of knowledge and decisional conflict will be done at 4 points after randomization.
1) Before consultation for second follow up with the doctor
2) After consultation during second follow up with the doctor
3) Before consultation for third follow up with the doctor
4) After consultation for third follow up with the doctor

Primary outcome [2]

Decisional conflict assessed by validated Decisional conflict scale (DCS) questionnaire

Timepoint [2]

Secondary outcome [1]

Assessment of preparation for decision making is done by using 10 items with likert scale questionnaire.

Timepoint [1]

Randomization is done by random block by week. Patients will be randomized to either intervention or control according to the weeks they come for follow up.
For each control and intervention group, assessment of satisfaction with preparation for decision making will be done at 3 points after randomization.

1) After consultation during second follow up with the doctor
2) Before consultation for third follow up with the doctor
3) After consultation for third follow up with the doctor

Eligibility

Key inclusion criteria

1) Patient who are diagnosed with localized prostate cancer (stage 1 and stage 2) in (0-16 weeks of diagnosing)
who has not make any decision about treatment option.

2) Being candidates with at least two treatment option.

Minimum age

50 Years

Maximum age

85 Years

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

1) Patients who are ill (patient who might have a symptoms of e.g urinary retention and not feeling comfortable during the assessment session)

2) Patients refuse to involve in the research project.
3) Patient with cognitive impairment.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomization were done by permuted block by week. Allocation of control or intervention group by week involved contacting the holder of the allocation schedule who is “off-site” or at central administration site.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Statistical Package For Social Science Programmed(SPSS)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2014

Actual

31/07/2014

Date of last participant enrolment

Anticipated

30/06/2015

Actual

28/02/2015

Date of last data collection

Anticipated

Actual

31/05/2015

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Kuala Lumpur

Country [2]

Malaysia

State/province [2]

Selangor

Country [3]

Malaysia

State/province [3]

Pulau Pinang

Country [4]

Malaysia

State/province [4]

Johor

Funding & Sponsors

Funding source category [1]

University

Name [1]

University Putra Malaysia

Address [1]

The Office of The Deputy Vice Chancellor
(Research & Innovation)
Universiti Putra Malaysia
43400 UPM Serdang, Selangor

Country [1]

Malaysia

Primary sponsor type

University

Name

University Putra Malaysia

Address

The Office of The Deputy Vice Chancellor
(Research & Innovation)
Universiti Putra Malaysia
43400 UPM Serdang, Selangor

Country

Malaysia

Secondary sponsor category [1]

University

Name [1]

Department of surgery,
Faculty of Medicine,
University of Malaya

Address [1]

Department of surgery,
Faculty of Medicine,
University of Malaya
50603 Kuala Lumpur

Country [1]

Malaysia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Office of the Deputy Vice Chancellor
(Research and Innovation)
Universiti Putra Malaysia
43400 Serdang, Selangor, Malaysia

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

Approval date [1]

16/04/2014

Ethics approval number [1]

Ethics committee name [2]

Malaysia Medical Research and Ethic Committee

Ethics committee address [2]

Secretariat of National Institutes of Health (NIHSEC)
c/o Institute for Health Management
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur

Ethics committee country [2]

Malaysia

Date submitted for ethics approval [2]

01/05/2014

Approval date [2]

31/07/2014

Ethics approval number [2]

NMRR-14-494-20143

Summary

Brief summary

To evaluate the effectiveness of patient decision aid on knowledge, decisional conflict and satisfaction with preparation for decision making in treatment option for localized prostate cancer patients in Referral Hospitals in Peninsular Malaysia.

Trial website

Trial related presentations / publications

NB JALIL, PY LEE, TA ONG, et al. Multi-center randomized controlledtrial on a decision aid for localizedprostate cancer in referral hospitalsin West-Coast Peninsular Malaysia. BJUI 2015. 116:S4;17.

Public notes

Contacts

Principal investigator

Name

A/Prof Dr.Lee Ping Yein

Address

Department of Family Medicine,
Faculty of Medicine and Health sciences,
University Putra Malaysia,
43400 UPM Serdang
Selangor Darul Ehsan

Country

Malaysia

Phone

+60 3 89472538

Fax

+60 3 89472328

[email protected]

Contact person for public queries

Name

Lee Ping Yein

Address

Department of Family Medicine,
Faculty of Medicine and Health Sciences,
43400 Universiti Putra Malaysia, Serdang
Selangor Darul Ehsan

Country

Malaysia

Phone

+60389472545

Fax

+60 3 89472328

[email protected]

Contact person for scientific queries

Name

Lee Ping Yein

Address

Department of Family Medicine,
Faculty of Medicine and Health sciences,
University Putra Malaysia,
43400 UPM Serdang
Selangor Darul Ehsan

Country

Malaysia

Phone

+60 3 89472538

Fax

+60 3 89472328

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effectiveness of Decision Aid in Men with Localized Prostate Cancer: a Multicenter Randomized Controlled Trial at Tertiary Referral Hospitals in an Asia Pacific Country.	2022	https://dx.doi.org/10.1007/s13187-020-01801-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically