Prostate Cancer
Conditions
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.
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.
Interventions
BEHAVIORALHealium
web-based platform to elicit patients' preferences about prostate cancer treatment and designed for low health literature populations
Sponsors
American Cancer Society, Inc.
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Mood States- Short form | 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. |
| Profile of Mood States-Short form | 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. |
Countries
United States
Outcome results
None listed