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Not yet recruiting NCT07280897

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCIPI.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Satisfaction with Decision (SWD) [Time frame: 3-month follow-up (T2) and 6-month follow-up (T3)]
Secondary outcome measures (1)
  • Quality of Life (FACT-G) [Time frame: Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The University of Texas Health Science Center at San Antonio School of Nursing — San Antonio

Identifiers

NCT: NCT07280897 · STUDY00001556 · E06709.1a

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗