SCIPI for Prostate Cancer

(SCIPI Trial)

Overseen By Lixin Song, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Metastatic cancer, Other malignancy, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program called SCIPI, designed to assist men with localized prostate cancer and their families. The program provides easy-to-understand information, tools for doctor communication, and social support. Researchers aim to determine if SCIPI can complement regular prostate cancer care and help patients feel more confident about their treatment choices while improving their quality of life. Men newly diagnosed with localized prostate cancer who can access the internet are encouraged to participate. Participants will either use the SCIPI program or continue with their usual care, and researchers will track their experiences over time. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance prostate cancer care for future patients.

What prior data suggests that SCIPI is safe for prostate cancer patients?

Past studies on SCIPI, a web-based support program for prostate cancer patients, have shown no safety concerns. This program is not a medical treatment like a drug or surgery. Instead, it provides information and support to help patients make informed decisions about their care. As a digital tool, SCIPI avoids the risks associated with physical treatments. Participants use it to access information and connect with others, which is generally safe and well-tolerated. Research on this type of support program has reported no negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SCIPI for prostate cancer because it introduces a new way to support patients through a web-based program, enhancing their care experience via Epic MyChart. Unlike traditional treatments that focus solely on medical interventions like surgery, radiation, or hormone therapy, SCIPI aims to improve overall patient well-being by integrating supportive care directly into their usual healthcare routine. This innovative approach may help patients manage symptoms and improve their quality of life, making treatment a more holistic experience.

What evidence suggests that SCIPI is effective for prostate cancer?

Research has shown that online programs like SCIPI, which participants in this trial may receive, can help men with localized prostate cancer. In similar programs, participants developed better coping skills and experienced an improved quality of life. One study found that men using a similar program felt more confident about their treatment choices. This suggests SCIPI might help patients feel more supported and informed. Although SCIPI is still under study in this trial, early results appear promising for enhancing patient care and decision-making. ^{1 6 7 8 9}

Who Is on the Research Team?

Lixin Song, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for men newly diagnosed with localized prostate cancer. It aims to see if a web-based program, SCIPI, can be integrated into clinical care and if it helps patients feel more confident in their treatment decisions and improves their quality of life.

Inclusion Criteria

Able to read and understand English or Spanish

Access to the internet and Epic MyChart patient portal at a participating study site (UTHSA, UNC, UCSD, KUMC)

Willing and able to provide informed consent

Exclusion Criteria

Severe cognitive impairment or psychiatric illness

Inability to access the internet or MyChart portal

Prior participation in other related digital health trials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants provide informed consent and complete the baseline assessment (T1)

1 week

Intervention

Participants are randomly assigned to either the SCIPI intervention or usual care

6 months

Web-based interaction via Epic MyChart

Follow-up

Participants are monitored for decision satisfaction, quality of life, and other outcomes

6 months

Data collection at 3 months (T2) and 6 months (T3)

What Are the Treatments Tested in This Trial?

Interventions

• SCIPI

Trial Overview The study is testing the Support, Communication, and Information Program for Prostate Cancer - Interactive (SCIPI), which provides information, decision-making tools, and social support. Participants will either use SCIPI or receive usual care to compare outcomes.

How Is the Trial Designed?

Group I: SCIPI Experimental Treatment 1 Intervention

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

Group II: Usual Care Active Control 1 Intervention

Participants will receive usual care provided at their study site.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07280897?cond=cancer

Study Details | NCT07280897 | SCIPI Implementation and ... SCIPI provides men with localized prostate cancer and their families with easy-to-understand information, tools to prepare for discussions with their doctors, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405631622000690

Lymphocyte-sparing pelvic radiotherapy for prostate cancer For prostate bed plans, the V40Gy for Ls-BM, Il-BM, and Lp-BM was decreased by 25 %, 59 %, 56 %, respectively. For Wp-BM, the V10Gy, V20Gy, and Dmean have been ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4670576/

Feasibility, acceptability, and preliminary efficacy of a ... Our overall findings are similar to a CBSM intervention for men with early-stage prostate cancer in which participants demonstrated significant ...

4. nature.com nature.com/articles/s41746-024-01167-9

Development of an effective predictive screening tool for ... When predicting high risk cancer in the validation cohort, ClarityDX Prostate showed 95% sensitivity, 35% specificity, 54% positive predictive ...

5. ar.iiarjournals.org ar.iiarjournals.org/content/35/7/4177

Image-guided Intensity-modulated Radiotherapy for ... Results: After a median observation time of 26 (range=15-48) months, the 3-year biochemical failure-free survival was 96.5% [95% confidence interval (CI)=89%-98 ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK599587/

Treatment Decision Support for Men with Prostate Cancer and ... We developed a tablet-based interactive knowledge model of PC to provide personalized and patient-centered information on treatment and outcomes for patients ...

7. nature.com nature.com/articles/s41591-021-01620-2

Artificial intelligence for diagnosis and Gleason grading of ... Gleason grading of biopsies yields important prognostic information for prostate cancer patients and is a key element for treatment planning.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025052806

Original Article Impact of target volume and dose concepts ... Data of prostate cancer patients receiving SBRT for spine BoM between 2010 and 2024 at 19 European cancer centers were retrospectively collected. Treatment ...

9. phiro.science phiro.science/article/S2405-6316(22)00069-0/fulltext

Lymphocyte-sparing pelvic radiotherapy for prostate cancer The aim of this study is to evaluate the feasibility of lymphocyte-rich organs at risk (LOAR) sparing in pelvic irradiation for localized prostate cancer.