Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCIPI | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SCIPI
- description
- Participants will receive SCIPI, a web-based supportive care program delivered through the Epic MyChart system, in addition to usual care.
- interventionNames
- Behavioral: SCIPI
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Participants will receive usual care provided at their study site.
Primary outcomes (1)
- measure
- Satisfaction with Decision (SWD)
- timeFrame
- 3-month follow-up (T2) and 6-month follow-up (T3)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available