Prostate CancerSCIPINCT07280897
SCIPI Implementation and Evaluation: A Multi-site Proof-of-Concept Pilot Trial
A study testing SCIPI in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SCIPI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 29 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at San Antonio School of Nursing
San Antonio, Texas, 78229
Cheongin Im, Postdoctoral Research Fellow, PhD, MSN, 210-567-5120, imc@uthscsa.edu
Lixin Song, Vice Dean for Research and Scholarship Professor, PhD, 210-450-8917, songl2@uthscsa.edu
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- SCIPI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCIPIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SCIPI | Experimental | Participants will receive SCIPI, a web-based supportive care program delivered through the Epic MyChart system, in addition to usual care. Receives: Behavioral: SCIPI |
| Usual Care | No intervention | Participants will receive usual care provided at their study site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month follow-up (T2) and 6-month follow-up (T3)
Secondary outcomes (1)
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.
Measured: Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion29 Sep 2029 (estimated)
- Study completion29 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Kansas Medical Center, University of California, San Diego
- Responsible party
- Principal investigator, Lixin Song, The University of Texas Health Science Center at San Antonio
- Investigators
- Lixin Song, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280897
- Sponsor's protocol ID
- STUDY00001556
- Other IDs
- E06709.1a
- Acronym
- SCIPI
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07280897
- Acronym / sponsor ID
- SCIPI / STUDY00001556
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Kansas Medical Center, University of California, San Diego
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 29 Sep 2029 (estimated)
- Study completion
- 29 Sep 2029 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SCIPI | Experimental | Behavioral: SCIPIParticipants will receive SCIPI, a web-based supportive care program delivered through the Epic MyChart system, in addition to usual care. |
| Usual Care | No intervention | –Participants will receive usual care provided at their study site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCIPISCIPI (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. | Behavioural | SCIPI |
Primary outcome
Satisfaction with Decision (SWD)
Time frame: 3-month follow-up (T2) and 6-month follow-up (T3)
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.
1 secondary outcome
Quality of Life (FACT-G)
Time frame: Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lixin Song, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCIPI in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lixin Song, PhD (210-450-8561, songl2@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with Decision (SWD) (time frame: 3-month follow-up (T2) and 6-month follow-up (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.