NCT05800483

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

March 8, 2023

Last Update Submit

March 23, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    3 months post-baseline

Secondary Outcomes (2)

  • Profile of Mood States- Short form

    6 weeks post-baseline

  • Profile of Mood States-Short form

    3 months post-baseline

Study Arms (2)

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.

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).

Interventions

HealiumBEHAVIORAL

web-based platform to elicit patients' preferences about prostate cancer treatment and designed for low health literature populations

Healium

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsrequired to have a prostate, as this research was on prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwell Health

Manhasset, New York, 11030, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

  • 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.

    PMID: 37862103DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 5, 2023

Study Start

March 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 5, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)