SCIPI Implementation and Evaluation: A Multi-site Proof-of-Concept Pilot Trial

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.

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.