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NCT07280897Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
1 Dec 2025
Start date
1 Oct 2026
Primary completion date
29 Sept 2029
Lead sponsor
The University of Texas Health Science Center at San Antonio
NCT number
NCT07280897

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 1 Oct 2026 to the primary completion date, 29 Sept 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior participation in other related digital health trials.

Other illness

  • 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.

Other

  • Patients:
  • Inability to access the internet or the MyChart portal.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The University of Texas Health Science Center at San Antonio School of Nursing
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.