Care Planning for Prostate Cancer Patients on Active Surveillance
Abstract
To date, most newly diagnosed prostate cancers (PC) are low-grade and low-risk tumors that are confined to the prostate. Active surveillance is a safe, evidence-based strategy to manage men with low-risk PC to prevent "overtreatment" and a decrease in quality of life associated with active treatment. It involves close monitoring of the tumor with the intent to intervene with curative treatment (e.g., surgery) if disease progression is evident. In spite of the benefits of active surveillance, 90% of eligible patients opt for curative treatment. Furthermore, 25% of patients discontinue the active surveillance protocol within the first 2 years, and 50% do so within 5 years without evidence of cancer progression. Emotional distress related to the feeling of "doing nothing" while the cancer may be worsening, and changes in a patient s treatment-related preferences and values are reported as the leading factors behind discontinuing active surveillance. Therefore, an intervention is urgently needed to address these issues. We propose to adopt for men on active surveillance an efficacious, symptom management intervention [Prostate Cancer Patient Education Program; PCPEP], and assess its feasibility and acceptability. The PCPEP was originally developed and tested for low health literacy patients treated for early-stage PC. It involves the provision of tailored modules and coaching using telehealth methods to reduce distress levels, enhance symptom management (e.g., urinary incontinence and impotence), and address unmet informational and supportive care needs during follow-up care. Prior studies found that the PCPEP improved symptom management and self-efficacy beliefs among PC patients with low health literacy. As part of this adoption process (Phase 1), we will refine the CPI-Prostate modules and develop an Electronic Health Record (EHR)-based care plan for the patient and care provider. The CPI-Prostate program will consist of four modules: (1) enhanced education on active surveillance and follow-up care; (2) a tailored care plan for the patient and the provider delivered in a paper- and EHR-format; (3) a one-on-one, navigator-led session with the patient to discuss the care plan and to assess and address psychological distress and unmet needs; and (4) four navigator-led calls to continue the assessment of distress and needs and to discuss updates to the care plan. We will conduct eight focus groups with 30 PC patients and 10 stakeholders to: (a) examine the barriers and facilitators of adherence to active surveillance, (b) explore patients unmet needs, and (c) inform the adoption process of the intervention modules, and the content and function of the EHR-based care plan. We will conduct usability testing to examine the utility of the penultimate version of the EHR-based care plan among 10 patients and stakeholders (50% PC patients) following National Institutes of Health guidelines. During the pilot feasibility and acceptability study (Phase 2), patients (N = 80) who are currently on active surveillance protocol will attend a 1-hour session with the navigator, followed by four navigator-led follow-up calls. Outcome measures will be assessed at baseline (before the session), and at 1, 3, 6, and 12 months thereafter. The primary outcome will be the feasibility and acceptability of the intervention and adherence to active surveillance. Secondary outcomes are psychological distress, unmet needs, decisional regret, uncertainty, fear of cancer progression, quality of life, and satisfaction with care and communication. We hypothesize that the CPI-Prostate will be highly acceptable and feasible. Although the study is not designed to test for efficacy, we also hypothesize that patients who participate in the CPI-Prostate will report adherence to active surveillance, a significant decline in distress, unmet needs, and regret, and a significant improvement in quality of life and satisfaction with care and with communi
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Apr 04, 2016
- Source ID
- W81XWH1510532
Entities
People
- Nihal Mohamed
Organizations
- Icahn School of Medicine at Mount Sinai
- United States Army