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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] 284790 0
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) 292164 0
Condition category
Condition code
Cancer 292502 292502 0 0
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] 289580 0
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] 292362 0
Knowledge assessed by validated Prostate cancer Knowledge questionnaire
Timepoint [1] 292362 0
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] 292470 0
Decisional conflict assessed by validated Decisional conflict scale (DCS) questionnaire
Timepoint [2] 292470 0
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
Secondary outcome [1] 308774 0
Assessment of preparation for decision making is done by using 10 items with likert scale questionnaire.
Timepoint [1] 308774 0
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?
No
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
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6136 0
Malaysia
State/province [1] 6136 0
Kuala Lumpur
Country [2] 6159 0
Malaysia
State/province [2] 6159 0
Selangor
Country [3] 6160 0
Malaysia
State/province [3] 6160 0
Pulau Pinang
Country [4] 6161 0
Malaysia
State/province [4] 6161 0
Johor

Funding & Sponsors
Funding source category [1] 289406 0
University
Name [1] 289406 0
University Putra Malaysia
Country [1] 289406 0
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] 288089 0
University
Name [1] 288089 0
Department of surgery,
Faculty of Medicine,
University of Malaya
Address [1] 288089 0
Department of surgery,
Faculty of Medicine,
University of Malaya
50603 Kuala Lumpur
Country [1] 288089 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291169 0
Ethics committee address [1] 291169 0
Ethics committee country [1] 291169 0
Malaysia
Date submitted for ethics approval [1] 291169 0
Approval date [1] 291169 0
16/04/2014
Ethics approval number [1] 291169 0
Ethics committee name [2] 301058 0
Malaysia Medical Research and Ethic Committee
Ethics committee address [2] 301058 0
Ethics committee country [2] 301058 0
Malaysia
Date submitted for ethics approval [2] 301058 0
01/05/2014
Approval date [2] 301058 0
31/07/2014
Ethics approval number [2] 301058 0
NMRR-14-494-20143

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49150 0
A/Prof Dr.Lee Ping Yein
Address 49150 0
Department of Family Medicine,
Faculty of Medicine and Health sciences,
University Putra Malaysia,
43400 UPM Serdang
Selangor Darul Ehsan
Country 49150 0
Malaysia
Phone 49150 0
+60 3 89472538
Fax 49150 0
+60 3 89472328
Email 49150 0
yein@upm.edu.my
Contact person for public queries
Name 49151 0
Lee Ping Yein
Address 49151 0
Department of Family Medicine,
Faculty of Medicine and Health Sciences,
43400 Universiti Putra Malaysia, Serdang
Selangor Darul Ehsan
Country 49151 0
Malaysia
Phone 49151 0
+60389472545
Fax 49151 0
+60 3 89472328
Email 49151 0
yein@upm.edu.my
Contact person for scientific queries
Name 49152 0
Lee Ping Yein
Address 49152 0
Department of Family Medicine,
Faculty of Medicine and Health sciences,
University Putra Malaysia,
43400 UPM Serdang
Selangor Darul Ehsan
Country 49152 0
Malaysia
Phone 49152 0
+60 3 89472538
Fax 49152 0
+60 3 89472328
Email 49152 0
yein@upm.edu.my

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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of Decision Aid in Men with Localized Prostate Cancer: a Multicenter Randomized Controlled Trial at Tertiary Referral Hospitals in an Asia Pacific Country.2022https://dx.doi.org/10.1007/s13187-020-01801-6
N.B. These documents automatically identified may not have been verified by the study sponsor.