Prostate Cancer
Conditions
Brief summary
This study will test a web-based supportive care program called the Support, Communication, and Information Program for Prostate Cancer - Interactive (SCIPI). SCIPI provides men with localized prostate cancer and their families with easy-to-understand information, tools to prepare for discussions with their doctors, and opportunities for social support. The purpose of this pilot study is to determine whether it is feasible to integrate SCIPI in prostate cancer clinical care via the electronic medical record and whether SCIPI may improve patients' confidence in making treatment decisions and their overall quality of life compared with usual care. The study will include patients who are newly diagnosed with prostate cancer. Participants will be randomly assigned to use SCIPI or to receive usual care, and information will be collected over time about their experiences, decision-making, and quality of life.
Detailed description
This proof-of-concept pilot randomized clinical trial aims to test the feasibility and preliminary efficacy of SCIPI, a web-based supportive care intervention for patients with localized prostate cancer. The study will enroll 200 newly diagnosed patients across four NCI-designated cancer centers, with the option for family members to participate. After providing informed consent and completing the baseline assessment (T1), participants will be randomly assigned to either the SCIPI intervention or usual care. Data will be collected at 3 months (T2) and 6 months (T3) to evaluate decision satisfaction, quality of life, symptom burden, self-efficacy, and program usability.
Interventions
BEHAVIORALSCIPI
SCIPI (Support, Communication, and Information Program for Prostate Cancer - Interactive) is a web-based supportive care program delivered through the Epic MyChart system. The program provides tailored educational materials, skills training, and interactive tools to support informed treatment decision-making for patients with localized prostate cancer.
Sponsors
University of North Carolina, Chapel Hill
University of Kansas Medical Center
University of California, San Diego
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Data collection staff are masked to group assignment; participants and providers are not masked.
Intervention model description
Participants will be randomized in a 1:1 ratio to either the SCIPI intervention or usual care. Randomization will be stratified by study site (KUMC, UCSD, UNC, UTHSA), and implemented in REDCap using permuted blocks with variable block sizes. Each participant remains in the assigned group for the duration of the study; there is no crossover.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with localized prostate cancer: * Age ≥ 18 years. * Biopsy-confirmed diagnosis of localized prostate cancer (Gleason score ≤8, PSA \< 30 ng/mL). * Eligible for curative-intent treatment (e.g., surgery, radiation, or active surveillance). * Able to read and understand English or Spanish. * Access to the internet and the Epic MyChart patient portal at a participating study site (UTHSA, UNC, UCSD, or KUMC). * Willing and able to provide informed consent.
Exclusion criteria
Patients: * History of metastatic or recurrent prostate cancer. * Diagnosis of another active malignancy (excluding non-melanoma skin cancer). * Severe cognitive impairment or psychiatric illness that would interfere with participation. * Inability to access the internet or the MyChart portal. * Prior participation in other related digital health trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with Decision (SWD) | 3-month follow-up (T2) and 6-month follow-up (T3) | SWD will be assessed using the 6-item Satisfaction with Decision (SWD) scale, which measures the extent to which participants feel informed, confident, and satisfied with their prostate cancer treatment decision. Scores range from 6 to 30, with higher scores indicating greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (FACT-G) | Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3) | Quality of life will be measured using Functional Assessment of Cancer Therapy - General (FACT-G). A 27-item validated questionnaire assessing physical, social/family, emotional, and functional well-being. Higher scores indicate better quality of life. |
Countries
United States
Contacts
Primary ContactLixin Song, PhD
Backup ContactCheongin Im, PhD
Outcome results
None listed