Interactive Decision Aid for Men Diagnosed With Prostate Cancer

April 15, 2024 updated by: Dr. Heiddis B Valdimarsdottir, Reykjavik University

Developing and Testing an Interactive Decision Aid for Newly Diagnosed Prostate Cancer Patients

Prostate cancer is the second leading cause of cancer related deaths in the western world (National Cancer Institute, 2011). Prostate cancer diagnosis relates to significant psychological distress (Roesch et al, 2005; Hervouet et al, 2005). The management options available for men with localized prostate cancer typically offer similar survival rate and one treatment has not been determined more effective than other. Variance in severity, duration and frequency of side effects between treatments is considerable (National Cancer Institute, 2011). This can make the choice between management options challenging and distressing. Researches show that patients that are actively involved and provided with sufficient information have better health outcomes (Stewart, 1995).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Valgerdur K Eiriksdottir, MSc
  • Phone Number: 003548690404
  • Email: valgerdure@ru.is

Study Locations

  • Iceland
      • Reykjavik, Iceland, 102
        • Reykjavik University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed with localized prostate cancer.

Exclusion Criteria:

  • Reads and understands Icelandic
  • Can give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
The control group will receive standard care for localized prostate cancer, i.e., information from their doctor and an information brochure.
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in decisional conflict over time
Time Frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
The Decisional Conflict Scale (DCS) is a measure that was designed to evaluate health-care-consumer decisions. It is a 16-item measure and the answers range from "strongly agree" to "strongly disagree" on a five point Likert scale. Scores on DCS range from 0 to 100, were higher score indicate greater decisional conflict. It has test-retest reliability of 0.81 and internal consistency ranges from α=.0.78 to 0.92.
Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in decisional regret over time
Time Frame: 2 weeks, 1 month, 3 months and 6 months.
The Decision Regret Scale (DRS) measures regret after health care decision. It is a 5-item measure and the answers range from "strongly agree" to "strongly disagree" on a five point Likert scale. Scores on DRS range from 0 to 100, were higher score indicate more regret after health care decision. It has good internal consistency that ranges from α=.0.81 to 0.92.
2 weeks, 1 month, 3 months and 6 months.
Change in satisfaction with decision over time
Time Frame: 2 weeks, 1 month, 3 months and 6 months.
The Satisfaction with Decision Scale (SWDS) measures satisfaction with health care decision. It is a 5-item measure and the answers range from "strongly agree" to "strongly disagree" on a five point Likert scale. Scores on SWDS range from 5 to 25, were higher score indicate more satisfaction with a decision.The scale has good internal consistency (α=.0.86).
2 weeks, 1 month, 3 months and 6 months.
Change in anxiety over time
Time Frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
The Generalized Anxiety Disorder - 7 (GAD-7) is a 7-item measure used to screen for general anxiety disorder and to measure its severity. It is also a good screening tool for social anxiety disorder, panic disorder and post traumatic stress disorder. Response options range from "not at all" to "several days" on a 4-point Likert scale. GAD-7 total score ranges from 0 to 21, were higher score indicates more severe anxiety. It has excellent internal consistency (α = 0.92).
Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in depression over time
Time Frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
The Patient Health Questionnaire (PHQ-9) is a widely used and well validated measure used to screen for depression and assess severity of it. It is a 9-item scale and answers are on 4-point Likert scale ranging from "not at all" to "nearly every day". PHQ-9 total score ranges from 0 to 27, were higher score indicates more severe depression. PHQ-9 has been shown to be a reliable and valid measure.
Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in Stress over time
Time Frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
The Perceived Stress Scale (PSS-10) is a 10-item scale used to measure stress. Each item on the list is rated on a five point Likert scale ranging from "never" to "very often". PSS-10 total score ranges from 0 to 40, were higher score indicates higher perceived stress. The PSS has adequate reliability and validity.
Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in Stress over time
Time Frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
The NCCN Distress Thermometer and checklist is a widely used screening measure for distress in cancer patients. It consists of a distress thermometer where participants assess their distress on a scale from 0 to 10, were 0 indicates no distress and 10 extreme distress. Additionally participants answer a problem checklist with several domains to identify what area of life distresses the participant.
Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in Cancer related Stress over time
Time Frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
The Impact of events scale-revised (IES-R) is a widely used questionnaire that measures trauma related stress, that is cancer specific distress. It is a 22-item measure that includes three factors; avoidance, hyper arousal and intrusion. Those factors together form a cancer-specific distress measure and the higher the score on the scale suggest more distress. Total score range from 0 to 88. The IES-R has high internal consistency and test-retest reliability ranges from 0.51-0.94.
Baseline, 2 weeks, 1 month, 3 months and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control preference
Time Frame: Baseline
The control preference scale (CPS) assesses the patient's preferred role in the decision-making process. It measures how people with life-threatening illnesses make treatment decisions. It measures the degree of control a person wants to have when making a medical treatment management decision.The scale is a single item and displays five possible roles of patient in decision making, that is fully passive, semi-passive, collaborative, semi-active and fully active.
Baseline
Localized Prostate cancer knowledge
Time Frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
The localized prostate cancer knowledge scale is a 9-item list that assesses participants knowledge of localized prostate cancer and prostate cancer management options. The scale was developed for this study based on method used by Berger, Grønberg, Loge, Kaasa and Sand (2018). Total score range from 0 to 9, were higher score indicates better knowledge of localized prostate cancer and prostate cancer management options.
Baseline, 2 weeks, 1 month, 3 months and 6 months.
Health Information Orientation
Time Frame: Baseline
The Health Information Orientation Scale (HIOS) measures underlying reasons for avoiding or seeking information in health context. The scale consists of 8 items and has two factors, that is information engagement and information apprehension. Both factors show adequate construct validity and reliability. Total score range from 0 to 32, were higher score indicates greater information apprehension and information engagement.
Baseline
Intolerance of uncertainty
Time Frame: Baseline
The Intolerance of uncertainty-12 (IUS-12) measures response to ambiguous situation and uncertainty. The scale consists of 12 items. Total score range from 12 to 60, where higher score indicates greater intolerance of uncertainty. The IUS shows good psychometric properties.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reykjavik University

Collaborators

The Icelandic Research Fund
The Icelandic Cancer Society

Investigators

  • Principal Investigator: Heiddis B Valdimarsdottir, PhD, Reykjavik University
  • Study Director: Birna Baldursdottir, PhD, Reykjavik University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2020

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSN-18-127
  • 141490-052 (Other Grant/Funding Number: The Icelandic Research Fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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