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| ID | Type | Description | Link |
|---|---|---|---|
| E06709.1a | Other Grant/Funding Number | Department of Defense (DOD) |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| University of Kansas Medical Center | OTHER |
| University of California, San Diego | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCIPI | Experimental | Participants will receive SCIPI, a web-based supportive care program delivered through the Epic MyChart system, in addition to usual care. |
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| Usual Care | No Intervention | Participants will receive usual care provided at their study site. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCIPI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with Decision (SWD) | 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. | 3-month follow-up (T2) and 6-month follow-up (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (FACT-G) | Quality of life will be measured using Functional Assessment of Cancer Therapy - General (FACT-G). A 27-item validated questionnaire assessing physical, social/family, emotional, and functional well-being. Higher scores indicate better quality of life. | Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3) |
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Inclusion Criteria:
Patients with localized prostate cancer:
Exclusion Criteria:
Patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lixin Song, PhD | Contact | 210-450-8561 | songl2@uthscsa.edu | |
| Cheongin Im, PhD | Contact | 210-567-5102 | imc@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lixin Song, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio School of Nursing | San Antonio | Texas | 78229 | United States |
De-identified individual participant data (IPD) will be shared with colleagues at all participating sites and with other researchers as requested and approved by the Principal Investigator.
The IPD will be available for sharing after study completion and final data analysis. Summary results will be posted on ClinicalTrials.gov within one year after the study reaches its Primary Completion Date. Published data will be shared once the corresponding manuscript has been accepted and published in a peer-reviewed journal.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Participants will be randomized in a 1:1 ratio to either the SCIPI intervention or usual care. Randomization will be stratified by study site (KUMC, UCSD, UNC, UTHSA), and implemented in REDCap using permuted blocks with variable block sizes. Each participant remains in the assigned group for the duration of the study; there is no crossover.
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Data collection staff are masked to group assignment; participants and providers are not masked.
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |