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

NCT07280897 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00001556E06709.1a
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life (FACT-G)

  Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3)

Study Arms (2)

SCIPI

EXPERIMENTAL

Participants will receive SCIPI, a web-based supportive care program delivered through the Epic MyChart system, in addition to usual care.

Behavioral: SCIPI

Usual Care

NO INTERVENTION

Participants will receive usual care provided at their study site.

Interventions

SCIPI BEHAVIORAL

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.

SCIPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• University of North Carolina, Chapel Hill: collaborator
• University of Kansas Medical Center: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio School of Nursing

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lixin Song, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lixin Song, PhD

CONTACT

210-450-8561; songl2@uthscsa.edu

Cheongin Im, PhD

CONTACT

210-567-5102; imc@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collection staff are masked to group assignment; participants and providers are not masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Full Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 29, 2029
• Study Completion (Estimated): September 29, 2029
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)