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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614000668606 |
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Date of registration:
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25/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of patient decision aid for Localized Prostate cancer patients in Referral hospitals in peninsular Malaysia.
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Scientific title:
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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 |
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Date of first enrolment:
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31/07/2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12614000668606.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);
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Phase:
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Not Applicable
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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A/Prof Lee Ping Yein
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Address:
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Department of Family Medicine,
Faculty of Medicine and Health sciences,
University Putra Malaysia,
43400 UPM Serdang
Selangor Darul Ehsan
Malaysia |
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Telephone:
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+60 3 89472538 |
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Email:
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yein@upm.edu.my |
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Affiliation:
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Name:
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A/Prof Lee Ping Yein
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Address:
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Department of Family Medicine,
Faculty of Medicine and Health Sciences,
43400 Universiti Putra Malaysia, Serdang
Selangor Darul Ehsan
Malaysia |
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Telephone:
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+60389472545 |
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Email:
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yein@upm.edu.my |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
50 Years
Age maximum:
85 Years
Gender:
Males
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Health Condition(s) or Problem(s) studied
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Prostate Cancer (Stage 1 and stage 2);
Prostate Cancer (Stage 1 and stage 2)
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Cancer - Prostate
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Intervention(s)
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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.
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Primary Outcome(s)
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Decisional conflict assessed by validated Decisional conflict scale (DCS) questionnaire
[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]
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Knowledge assessed by validated Prostate cancer Knowledge questionnaire
[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
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Secondary Outcome(s)
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Assessment of preparation for decision making is done by using 10 items with likert scale questionnaire.
[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
]
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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University Putra Malaysia
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Ethics review
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Status: Approved
Approval date:
Contact:
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Status: Approved
Approval date:
Contact:
Malaysia Medical Research and Ethic Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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