SCIPI Implementation and Evaluation: A Multi-site Proof-of-Concept Pilot Trial

The University of Texas System (UT)

Status

Begins enrollment in 7 months

Conditions

Prostate Cancer

Treatments

Behavioral: SCIPI

Study type

Interventional

Funder types

Other

Identifiers

NCT07280897

E06709.1a (Other Grant/Funding Number)

STUDY00001556

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.