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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Satisfaction with Decision (SWD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data collection staff are masked to group assignment; participants and providers are not masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Satisfaction with Decision (SWD)
时间窗: 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.
Satisfaction with Decision (SWD)
时间窗: 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.
次要结局
- Quality of Life (FACT-G)(Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3))
- Quality of Life (FACT-G)(Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3))
研究者
Lixin Song
Tenured Full Professor
The University of Texas Health Science Center at San Antonio