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Completed

NCT Number: NCT05800483

Improving Decision-Making for Low Health Literate Prostate CA Patients

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northwell Health, Manhasset, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • none

Treatment and study plan

Healium

Behavioral

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Profile of Mood States- Short form

    Time frame: 6 weeks post-baseline

    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.

  2. Profile of Mood States-Short form

    Time frame: 3 months post-baseline

    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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2023
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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