Prostate CancerNCT04260737
Interactive Decision Aid for Men Diagnosed With Prostate Cancer
A study testing Decision Aid for Men with Localized Prostate Cancer in people with Prostate Cancer, run by Reykjavik University at 1 site in Iceland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Decision Aid for Men with Localized Prostate Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteIceland
- Study dates
- 26 Feb 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with localized prostate cancer.
Who cannot join
- Reads and understands Icelandic
- Can give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
- Conditions
- Prostate Cancer
- Being tested
- Decision Aid for Men with Localized Prostate Cancer
- Keywords
- Localized Prostate Cancer, Decision Aid, Medical Decision Making
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid for Men with Localized Prostate CancerOther
The intervention is an interactive decision aid aimed to assist newly diagnosed prostate cancer patients with their treatment management options.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | The control group will receive standard care for localized prostate cancer, i.e., information from their doctor and an information brochure. |
| Decision Aid + Standard Care | Experimental | 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. Receives: Other: Decision Aid for Men with Localized Prostate Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decisional conflict over time
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.
Measured: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in decisional regret over time
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.
Measured: 2 weeks, 1 month, 3 months and 6 months.
Change in satisfaction with decision over time
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).
Measured: 2 weeks, 1 month, 3 months and 6 months.
Change in anxiety over time
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).
Measured: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in depression over time
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.
Measured: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in Stress over time
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.
Measured: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in Stress over time
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.
Measured: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Change in Cancer related Stress over time
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.
Measured: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Secondary outcomes (4)
Control preference
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.
Measured: Baseline
Localized Prostate cancer knowledge
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.
Measured: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Health Information Orientation
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.
Measured: Baseline
Intolerance of uncertainty
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start26 Feb 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reykjavik University
- Sponsor type
- University, hospital or other
- Collaborators
- Icelandic Research Center, The Icelandic Cancer Society
- Responsible party
- Principal investigator, Dr. Heiddis B Valdimarsdottir, Reykjavik University
- Investigators
- Heiddis B Valdimarsdottir, PhD, Principal investigator, Reykjavik UniversityBirna Baldursdottir, PhD, Study director, Reykjavik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260737
- Sponsor's protocol ID
- VSN-18-127
- Other IDs
- 141490-052
- Status last verified
- Apr 2024
- First submitted
- 8 Jan 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16015462Hervouet 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.
PubMed 16310621Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
PubMed 7728691Berger 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.
PubMed 29614997
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing an Interactive Decision Aid for Newly Diagnosed Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04260737
- Acronym / sponsor ID
- VSN-18-127
- Conditions
- Prostate Cancer
- Keywords
- Localized Prostate Cancer, Decision Aid, Medical Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Reykjavik UniversityUniversity, hospital or other
- Collaborators
- Icelandic Research Center, The Icelandic Cancer Society
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –The control group will receive standard care for localized prostate cancer, i.e., information from their doctor and an information brochure. |
| Decision Aid + Standard Care | Experimental | Other: Decision Aid for Men with Localized Prostate CancerThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed with localized prostate cancer.
Key exclusion criteria (2 listed)
- Reads and understands Icelandic
- Can give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Aid for Men with Localized Prostate CancerThe intervention is an interactive decision aid aimed to assist newly diagnosed prostate cancer patients with their treatment management options. | Other | Decision Aid + Standard Care |
Primary outcome
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.
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.
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).
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).
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.
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.
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.
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.
4 secondary outcomes
Control preference
Time frame: Baseline
Localized Prostate cancer knowledge
Time frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.
Health Information Orientation
Time frame: Baseline
Intolerance of uncertainty
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 16015462Roesch 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.
- Background: PubMed 16310621Hervouet 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.
- Background: PubMed 7728691Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
- Background: PubMed 29614997Berger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiddis B Valdimarsdottir, PhD principal investigator
Reykjavik University
Birna Baldursdottir, PhD study director
Reykjavik University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid for Men with Localized Prostate Cancer in people with Prostate Cancer, run by Reykjavik University at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in decisional conflict over time (time frame: Baseline, 2 weeks, 1 month, 3 months and 6 months.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04260737, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.