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

Implementation and Evaluation of SCIPI: A Multi-Site Pilot Randomized Controlled Trial to Improve Decision-Making and Quality of Life Among Patients With Localized Prostate Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: SCIPI

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lixin Song, PhD; Phone Number: 210-450-8561; Email: songl2@uthscsa.edu
• Study Contact Backup: Name: Cheongin Im, PhD; Phone Number: 210-567-5102; Email: imc@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio School of Nursing
      • Contact: Cheongin Im, Postdoctoral Research Fellow, PhD, MSN; Phone Number: 210-567-5120; Email: imc@uthscsa.edu
      • Contact: Lixin Song, Vice Dean for Research and Scholarship Professor, PhD; Phone Number: 210-450-8917; Email: songl2@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants will receive usual care provided at their study site.
Experimental: SCIPI; Participants will receive SCIPI, a web-based supportive care program delivered through the Epic MyChart system, in addition to usual care.	Behavioral: SCIPI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Decision (SWD)	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.	3-month follow-up (T2) and 6-month follow-up (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (FACT-G)	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.	Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: University of California, San Diego; University of Kansas Medical Center; University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Lixin Song, PhD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 29, 2029
• Study Completion (Estimated): September 29, 2029

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Estimated): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STUDY00001556; E06709.1a (Other Grant/Funding Number: Department of Defense (DOD))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) will be shared with colleagues at all participating sites and with other researchers as requested and approved by the Principal Investigator.
• IPD Sharing Time Frame: The IPD will be available for sharing after study completion and final data analysis. Summary results will be posted on ClinicalTrials.gov within one year after the study reaches its Primary Completion Date. Published data will be shared once the corresponding manuscript has been accepted and published in a peer-reviewed journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No