Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey
研究概览
简要总结
The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners.
Participation of this study lasts for about for 16 weeks. Depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer.
Eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer education program, PERC) groups. They complete baseline (T1, prior to randomization) and 4-month post-T1 follow-up measures (T2).
详细描述
Methods: A two-group randomized controlled pretest-posttest design will be used and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, the investigators will assess the feasibility of ESCP by recruitment, enrollment, and retention rates, program satisfaction with the ESCP, and perceived ease of use of the ESCP. To achieve the secondary aim, the ESCP users will be compared with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL), secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms), and number of visits to post-treatment care services at T1 and T2. The primary and secondary outcomes are assessed using measurements with sound psychometrical properties. The investigators will use a qualitative and quantitative mixed methods approach to achieve the research aims.
Conclusions: The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility included men who:
- •were diagnosed with localized PC;
- •were within 16 weeks of completing their initial curative intent treatment [26] at genitourinary and radiation oncology clinics at two comprehensive cancer centers in the U.S southeast;
- •were not treated for another cancer in last year; and
- •had a partner > 18 years of age not receiving cancer treatment.
排除标准
- •Either member of couple unable to speak English
- •Unwilling/unable to provide Informed Consent
结局指标
主要结局
Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey
时间窗: during 4-month study period
Will evaluate the percentage of participants successfully following protocol, defined as completing the Follow-Up survey at the end of the study period among those who have been enrolled into the study (who completed the baseline).
Participant Satisfaction Scores
时间窗: at the 4 month followup
Program satisfaction determined by the 11-item Participant Satisfaction Scale measured the level of program satisfaction. The first to tenth items ranged from 1=not satisfied to 5=extremely satisfied. The eleventh item ranged from 1=extremely not to 4=definitely yes. Higher total score indicates greater program satisfaction
Percentage of Potentially Eligible Participants Actually Enrolled Into the Study
时间窗: after participants completed baseline survey
Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study
Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms
时间窗: during 4-month study period
The usage of Web-Based Intervention Sessions is determined by the percentage of participants who logged into the study website among those who have been randomly assigned to the intervention group. Patient-Reported Symptoms are determined by patient's responses on their appraisal of prostate cancer symptoms and general symptoms. 1=patient reported the symptom and the symptom webpage reviewed; 0=patient reported the symptom and no related webpage reviewed OR patient did not report the symptom but the webpage reviewed
Perceived Ease of Use Score
时间窗: at the 4 month followup
The 16-item Program Usability measures participants' assessment of their agreement with the ease of use of the program in terms of its general features, content, and navigation. The ranges of the total scores are (3,15), (4,20), (9,45) for general features, content, and navigation, respectively. The score of individual item ranges from1=strongly disagree to 5=strongly agree. Higher score indicates greater perceived ease of use.
次要结局
- Change in Dietary Risk Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II(Baseline upon enrollment, Month 4)
- Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline(Baseline upon enrollment, Month 4)
- Change in PROMIS Social Support-Emotional Support From Baseline to 4-months Post-Baseline(Baseline upon enrollment, Month 4)
- Change in Appraisal of Prostate Cancer-Specific Symptoms(Baseline upon enrollment, Month 4)
- Change in Appraisal of General Symptoms(Baseline upon enrollment, Month 4)
- Change in Physical Activity Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II(Baseline upon enrollment, Month 4)
- Change in FACT-G Scores(Baseline upon enrollment, Month 4)
- Healthcare Utilization Extracted From Electronic Medical Record(during the first 10 months after participants completed baseline survey)
- Change in PROMIS Social Support-Informational Support From Baseline to 4-Months Post-Baseline(Baseline upon enrollment, Month 4)
- Change in PROMIS Social Support-Instrumental Support From Baseline to 4-months Post-Baseline(Baseline upon enrollment, Month 4)