Interactive Decision Aid for Men Diagnosed With Prostate Cancer
NCT ID: NCT04260737
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
163 participants
INTERVENTIONAL
2020-02-26
2023-07-31
Brief Summary
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The study involves implementing interactive, web-based decision-aid to assist men with localized prostate cancer with their decision regarding their prostate cancer management options. Participants will be randomized to standard-care (SC) and SC + interactive decision-aid (IDA). The SC group will meet with their urologist and receive and information brochure. In addition the IDA group will receive a website that includes a wealth of information (e.g., overview about prostate cancer, overview of different treatment options, pros and cons of different treatment options and a value clarification exercise that is designed to assist participants to weigh the risks and benefits of each prostate cancer management option).
The effectiveness of the intervention will be evaluated with questionnaires administered prior to randomization (baseline) and then again two weeks, one, three and six months after the randomization.
Aim 1. Evaluate the relative impact of SC versus SC + IDA on medical decision making. It is hypothesized that participants randomized to the SC + IDA arms will have improved decision making (e.g., reduced decisional conflict) and psychosocial outcomes (e.g., distress), compared to those randomized to SC only.
Aim 2. Identify mechanisms by which the interventions impact patient outcomes. It is hypothesized that: 1) improved decision making and psychosocial outcomes for the IDA arms will be mediated by increased knowledge; 2) participants who are undecided about the treatment decision and those that have information-seeking decision styles will benefit most from the decision-aid interventions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Care
The control group will receive standard care for localized prostate cancer, i.e., information from their doctor and an information brochure.
No interventions assigned to this group
Decision Aid + Standard Care
The intervention group will receive standard care and intervention that includes a website with the Decision Aid which covers the following:
1. An overview about prostate cancer;
2. An overview of different treatment options (e.g. surgery and active surveillance)
3. The pros and cons of different treatment options (e.g., physical, emotional, social).
4. A value clarification exercise that is designed to assist participants to weigh the pros and cons of each prostate cancer management option.
Decision Aid for Men with Localized Prostate Cancer
The intervention is an interactive decision aid aimed to assist newly diagnosed prostate cancer patients with their treatment management options.
Interventions
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Decision Aid for Men with Localized Prostate Cancer
The intervention is an interactive decision aid aimed to assist newly diagnosed prostate cancer patients with their treatment management options.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Can give informed consent
18 Years
MALE
No
Sponsors
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The Icelandic Research Fund
UNKNOWN
The Icelandic Cancer Society
UNKNOWN
Reykjavik University
OTHER
Responsible Party
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Dr. Heiddis B Valdimarsdottir
Professor
Principal Investigators
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Heiddis B Valdimarsdottir, PhD
Role: PRINCIPAL_INVESTIGATOR
Reykjavik University
Birna Baldursdottir, PhD
Role: STUDY_DIRECTOR
Reykjavik University
Locations
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Reykjavik University
Reykjavik, , Iceland
Countries
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References
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Roesch SC, Adams L, Hines A, Palmores A, Vyas P, Tran C, Pekin S, Vaughn AA. Coping with prostate cancer: a meta-analytic review. J Behav Med. 2005 Jun;28(3):281-93. doi: 10.1007/s10865-005-4664-z.
Hervouet S, Savard J, Simard S, Ivers H, Laverdiere J, Vigneault E, Fradet Y, Lacombe L. Psychological functioning associated with prostate cancer: cross-sectional comparison of patients treated with radiotherapy, brachytherapy, or surgery. J Pain Symptom Manage. 2005 Nov;30(5):474-84. doi: 10.1016/j.jpainsymman.2005.05.011.
Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
Berger O, Gronberg BH, Loge JH, Kaasa S, Sand K. Cancer patients' knowledge about their disease and treatment before, during and after treatment: a prospective, longitudinal study. BMC Cancer. 2018 Apr 3;18(1):381. doi: 10.1186/s12885-018-4164-5.
Other Identifiers
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141490-052
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
VSN-18-127
Identifier Type: -
Identifier Source: org_study_id
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