Prostate CancerNCT05800483
Improving Decision-Making for Low Health Literate Prostate CA Patients
A study testing Healium in people with Prostate Cancer, run by Northwell Health at 2 sites in United States.
Trial summary
This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life. 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?
- Healium
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2020to 31 Dec 2022
- 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
- a diagnosis of localized prostate cancer and eligible for all treatment options (ie., surgery, radiation, active surveillance);
- had not yet made a treatment decision or begun treatment; and
- have basic proficiency (grade school level) in reading English.
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwell Health
Manhasset, New York, 11030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.
Read the detailed description
Background: Elicitation of patients' preferences is an integral part of shared decision making, the recommended approach for prostate cancer decision making. However, existing decision aids for this population do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patient's treatment preferences and is designed for a low health literate population. This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.
Method: Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, an extensive decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6-weeks and 3-months post-baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.
- Conditions
- Prostate Cancer
- Being tested
- Healium
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealiumBehavioural
web-based platform to elicit patients' preferences about prostate cancer treatment and designed for low health literature populations
| Study group | Role | What they receive |
|---|---|---|
| Healium | Experimental | Healium is a web-based platform that employs a user-centric design and aims to appeal to a low health literate population. It features a simple language and layout, a large font size, contrasting text and background colors, bright color palette, and use of short labels and headings to describe content. Receives: Behavioral: Healium |
| Comparison (Healing Choices) | No intervention | The Healing Choices program represents a virtual health center that patients visit to obtain disease and treatment-related information. The software was designed to be open to exploration with an intuitive layout, without restrictions in terms of order of access. Information is stored in virtual rooms, such as a library, a conference room showing videos by survivors who discuss their approach to treatment, and physician offices containing videos of physicians representing different treatment specialties. All information was extensively vetted by health education experts of the National Cancer Institute's Cancer Information Services (CIS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale
Decisional Conflict was measured with the Decisional Conflict Scale (DCS), a well-validated scale consisting of 16 items that assess four dimensions: informed, clarity, uncertainty, and support. The response ranges are on a 5-point Likert scale ranging from strongly agree to strongly disagree. To come up with a total score, the 16 items are summed, divided by 16 and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Measured: 6 weeks post-baseline
Decisional Conflict Scale
Decisional Conflict was measured with the Decisional Conflict Scale (DCS), a well-validated scale consisting of 16 items that assess four dimensions: informed, clarity, uncertainty, and support. The response ranges are on a 5-point Likert scale ranging from strongly agree to strongly disagree. To come up with a total score, the 16 items are summed, divided by 16 and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Measured: 3 months post-baseline
Secondary outcomes (2)
Profile of Mood States- Short form
The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. It is made of subscales for depression, tension, fatigue, confusion, anger, vigor and esteem-related affect. It consists of 30 items, each measured on a 5-point scale ranging from "not at all" to "extremely". A total score is calculated by summing the totals for the negative scales and subtracting the totals for the positive scales.
Measured: 6 weeks post-baseline
Profile of Mood States-Short form
The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. It is made of subscales for depression, tension, fatigue, confusion, anger, vigor and esteem-related affect. It consists of 30 items, each measured on a 5-point scale ranging from "not at all" to "extremely". A total score is calculated by summing the totals for the negative scales and subtracting the totals for the positive scales.
Measured: 3 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Mar 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800483
- Sponsor's protocol ID
- 15-192
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diefenbach MA, Marziliano A, Tagai EK, Pfister H, Lapitan E, Hall SJ, Vira M, Ibrahim S, Aibel K, Kutikov A, Horwitz EM, Miyamoto C, Reese AC, Miller SM. Preference Elicitation and Treatment Decision-Making Among Men Diagnosed With Prostate Cancer: Randomized Controlled Trial Results of Healium. J Med Internet Res. 2023 Oct 20;25:e46552. doi: 10.2196/46552.
PubMed 37862103
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Decision-Making for Low Health Literate Prostate CA Patients
- ClinicalTrials.gov ID
- NCT05800483
- Acronym / sponsor ID
- 15-192
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Apr 2023 (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.
This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.
Detailed description
Background: Elicitation of patients' preferences is an integral part of shared decision making, the recommended approach for prostate cancer decision making. However, existing decision aids for this population do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patient's treatment preferences and is designed for a low health literate population. This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.
Method: Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, an extensive decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6-weeks and 3-months post-baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healium | Experimental | Behavioral: HealiumHealium is a web-based platform that employs a user-centric design and aims to appeal to a low health literate population. It features a simple language and layout, a large font size, contrasting text and background colors, bright color palette, and use of short labels and headings to describe content. |
| Comparison (Healing Choices) | No intervention | –The Healing Choices program represents a virtual health center that patients visit to obtain disease and treatment-related information. The software was designed to be open to exploration with an intuitive layout, without restrictions in terms of order of access. Information is stored in virtual rooms, such as a library, a conference room showing videos by survivors who discuss their approach to treatment, and physician offices containing videos of physicians representing different treatment specialties. All information was extensively vetted by health education experts of the National Cancer Institute's Cancer Information Services (CIS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a diagnosis of localized prostate cancer and eligible for all treatment options (ie., surgery, radiation, active surveillance);
- had not yet made a treatment decision or begun treatment; and
- have basic proficiency (grade school level) in reading English.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Healiumweb-based platform to elicit patients' preferences about prostate cancer treatment and designed for low health literature populations | Behavioural | Healium |
Primary outcome
Decisional Conflict Scale
Time frame: 6 weeks post-baseline
Decisional Conflict was measured with the Decisional Conflict Scale (DCS), a well-validated scale consisting of 16 items that assess four dimensions: informed, clarity, uncertainty, and support. The response ranges are on a 5-point Likert scale ranging from strongly agree to strongly disagree. To come up with a total score, the 16 items are summed, divided by 16 and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Decisional Conflict Scale
Time frame: 3 months post-baseline
Decisional Conflict was measured with the Decisional Conflict Scale (DCS), a well-validated scale consisting of 16 items that assess four dimensions: informed, clarity, uncertainty, and support. The response ranges are on a 5-point Likert scale ranging from strongly agree to strongly disagree. To come up with a total score, the 16 items are summed, divided by 16 and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
2 secondary outcomes
Profile of Mood States- Short form
Time frame: 6 weeks post-baseline
Profile of Mood States-Short form
Time frame: 3 months post-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 5 Apr 2023.
- Derived from this study: PubMed 37862103Diefenbach MA, Marziliano A, Tagai EK, Pfister H, Lapitan E, Hall SJ, Vira M, Ibrahim S, Aibel K, Kutikov A, Horwitz EM, Miyamoto C, Reese AC, Miller SM. Preference Elicitation and Treatment Decision-Making Among Men Diagnosed With Prostate Cancer: Randomized Controlled Trial Results of Healium. J Med Internet Res. 2023 Oct 20;25:e46552. doi: 10.2196/46552.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healium in people with Prostate Cancer, run by Northwell Health at 2 sites in United States.
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 3 inclusion and 1 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Decisional Conflict Scale (time frame: 6 weeks post-baseline). The study lists 2 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 NCT05800483, which also lists 1 linked publication.
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 5 Apr 2023.