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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

TX