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

NCT ID: NCT07280897

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-10-01

Study Completion Date

2029-09-29

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Data collection staff are masked to group assignment; participants and providers are not masked.

Study Groups

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SCIPI

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

Group Type EXPERIMENTAL

SCIPI

Intervention Type 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.

Usual Care

Participants will receive usual care provided at their study site.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Lixin Song

Tenured Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lixin Song, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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

San Antonio, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Lixin Song, PhD

Role: CONTACT

Phone: 210-450-8561

Email: [email protected]

Cheongin Im, PhD

Role: CONTACT

Phone: 210-567-5102

Email: [email protected]

Facility Contacts

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Cheongin Im, Postdoctoral Research Fellow, PhD, MSN

Role: primary

Lixin Song, Vice Dean for Research and Scholarship Professor, PhD

Role: backup

Other Identifiers

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E06709.1a

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00001556

Identifier Type: -

Identifier Source: org_study_id