Prostate Carcinoma
Conditions
Brief summary
This clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT) for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in combination with learning preferences and individual disease characteristics to provide focused and guided knowledge on PC tailored to the individual patient. Using an AVCT to enhance patient education may improve patient understanding and result in higher patient satisfaction with treatment decisions amongst men with PC.
Detailed description
PRIMARY OBJECTIVES: I. To develop an adaptive virtual consultation tool for PC (AVCT): Ia. To incorporate and integrate the inputs from a diverse group of patients (including minorities), patient advocates, nursing, physicians and education experts in the design process for the adaptive consultation tool; Ib. Employ user centered iterative design approach to develop an adaptive learning tool on mobile devices that is tailored to individuals based on symptoms, health literacy, learning style, and disease specific characteristics. II. To assess the feasibility, acceptability and usability of AVCT: IIa. To validate the design approach and customization rules at the completion of the participatory design process using a convenience sample of subjects through assessment of system interaction logs and qualitative feedback from users on cognition, ease-of-use, usability and customization efficacy; IIb. To utilize the feasibility study results in (2a) to refine the interface, information presentation, and adaptive customization approach. III. To determine the efficacy of AVCT using a small-scale comparative study: IIIa. To design and execute a three arm comparative study consisting of adaptive virtual consultation, non-adaptive virtual consultation and standard-practice information-only control intervention and assess the comparative efficacy of the tool on the main outcome variable, satisfaction with health care episode; IIIb. To measure changes in other outcome variables at baseline, post-intervention, 3-month and 12-month duration; IIIc. To analyze the mediating influence of decision self-efficacy and a number of moderating factors including preference for decision-making participation and health literacy on outcome variables. OUTLINE: Patients are randomized to 1 of 3 arms. ARM 1: Patients participate in an adaptive virtual consultation on trial. ARM 2: Patients participate in a non-adaptive virtual consultation on trial. ARM 3: Patients receive information-only on trial. After completion of study intervention, patients are followed up at 3- and 12-months post treatment decision.
Interventions
BEHAVIORALHealth Education
Participate in an adaptive virtual consultation
OTHERInformational Intervention
Given information-only
OTHERSurvey Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* The participants in this study will be community dwelling, males with prostate cancer (PC) and their healthcare advocate, if applicable * Proficiency in English is required
Exclusion criteria
* Mental incompetency to participate in the study and/or no treatment option due to other health reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction measured by post utilization surveys | 3-month post treatment decision | Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools. Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern. |
| Health outcomes for cancer recurrence using PSA | Baseline | Measured by Prostate specific antigen ( PSA ) |
| Health outcomes for urinary function using IPSS | Baseline | Measured using International Prostate symptom score (IPSS) |
| Health outcomes for sexual function using SHIM score | Baseline | Measured using Sexual Health inventory for men (SHIM) score |
| Health outcomes for urinary function | 3-month post treatment decision | Measured using International Prostate symptom score (IPSS) |
| Health outcomes for sexual function | 3-month post treatment decision | Measured using Sexual Health inventory for men (SHIM) score |
Countries
United States
Outcome results
None listed