Stage III Prostate Cancer, Stage II Prostate Cancer, Stage I Prostate Cancer
Conditions
Brief summary
This randomized clinical trial studies how well visually enhanced education works in improving prostate cancer and treatment knowledge in patients with prostate cancer that has not spread to other places in the body. Visually enhanced education includes pictures, drawings, and photos, may help doctors better convey information about radiation and prostate cancer to patients.
Detailed description
PRIMARY OBJECTIVES: I. Our goal is to conduct a randomized controlled trial to determine the impact of a visual presentation in the context of a radiation oncologist's discussion with patient during consultation on patient satisfaction at end of consultation visit and at end of treatment, on anxiety at start of treatment, on decision regret following treatment, and on perception of side effects following treatment. Of note, the attending radiation oncologist will be responsible for reviewing the Powerpoint presentation with the patient, taking time to answer any questions that the patient has OUTLINE: Patients are randomized into 1 of 2 arms. ARM A (STANDARD EDUCATION): Patients receive a standard prostate cancer radiation oncology consultation. ARM B (VISUAL ENHANCED EDUCATION): Patients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation.
Interventions
OTHERStandard prostate cancer education presentation
Receive standard prostate cancer education presentation
OTHERVisually enhanced prostate cancer educational presentation
Receive visually enhanced prostate cancer educational presentation
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have non-metastatic, biopsy proven prostate cancer * Must be referred to radiation oncology clinic
Exclusion criteria
* Prior surgery or radiation therapy for prostate cancer * Patients who are blind are excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision-Regret - based on Ottawa scale | Up to 12 weeks | Sample size was determined based on this primary outcome - with estimated mean of 16 in Arm A and mean of 8 in Arm B, with standard deviation of 15, with 80% power and alpha of 0.05. |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction - SCA | baseline, end of treatment, and long-term follow-up |
| Symptoms based on EPIC-26 short form | baseline, end of treatment, and long-term follow-up |
| Anxiety - Memorial MAX-PC scale | 1 week |
Countries
United States
Outcome results
None listed