The Patient-Centered Outcomes Research Institute approved $44.4 million in funding for 21 new patient-centered comparative clinical effectiveness research studies.
Several studies will focus on cancer, including comparing ways to improve colorectal cancer screening, develop a more patient-centered approach to assessing the quality of care for people with cancer, and assessing the effectiveness of different treatment strategies for ductal carcinoma in situ among older women.
The funds will also support projects focusing on a range of conditions and problems that impose high burdens on patients, caregivers, and the healthcare system, including post-partum depression, misuse of antibiotics, post-traumatic stress disorder among veterans, and joint replacement among others.
The board also approved several studies that aim to reduce disparities in care, including a project testing the effectiveness of several strategies for improving outcomes for children with Down Syndrome who do not have access to specialty clinics.
The cancer-related studies include:
• Comparative Effectiveness Analyses Among Conservative Treatment Strategies for Ductal Carcinoma in Situ, at Yale University, is a two-year project with a budget of $439,730. The principal investigator is Shiyi Wang.
The goals of this study are to compare benefits, treatment burdens, and side effects between less-intensive treatment strategies among older DCIS patients.
Among women older than 67 years with DCIS, the study plans to compare the outcomes of “biopsy only plus observation/active surveillance” versus “immediate BCS without radiation therapy,” in terms of breast cancer-specific mortality, invasive breast cancer diagnosis, subsequent mastectomy, receipt of RT, and treatment burdens (including follow-up biopsy, imaging tests, and outpatient clinic visits).
Among older women with DCIS who have received BCS without radiation therapy, the study will compare the outcomes of receiving sentinel lymph node biopsy versus not receiving it, in terms of breast cancer-specific mortality, invasive breast cancer diagnosis, subsequent mastectomy, receipt of RT, and side effects (including lymphedema, pain, and limitation of movement of upper extremity).
• Ostomy Telehealth for Cancer Survivors, at the University of Arizona, is a three-year project with a budget of $2,080,650. The principal investigator is Robert Krouse.
A proposed ostomy self-management telehealth program, led by ostomy nurses with ostomy “peer-buddies” and patient/caregiver education and support, will use telehealth delivery to improve patients’ ability to participate, especially for elderly, rural, inner-city, or poor-health cancer survivors with ostomies. The study will compare patients participating in the telehealth program with patients receiving usual care, according to PCORI.
The first goal of the study is to determine if the program improves patient ostomy self-management knowledge and skills and health-related quality of life, and if this improvement continues six months after completing the program. The second goal is to determine the differences in patients’ use of family resources, use of medical care, and ostomy-related family financial burden between the program participants and patients receiving usual care.
• Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients, at Indiana University, is a four-and-a-half-year project with a budget of $2,880,644. The principal investigator is Susan Rawl.
The study will evaluate two interventions—a tailored DVD, and the DVD plus a patient navigator; compared with each other and with usual care—to increase CRC screening rates among a diverse sample of patients.
The study plans to enroll an ethnically diverse group of 750 men and women ages 50-75 who were referred and scheduled for colonoscopy at one endoscopy department but canceled or did not attend their scheduled appointment.
• In a previous set of approvals, in March, PCORI approved Comparison of Operative versus Medical Endocrine Therapy for Low Risk DCIS: The COMET Trial, a study being performed by the Alliance for Clinical Trials in Oncology. The five-year project has a budget of $13,399,702. The principal investigator is Shelley Hwang.
The primary objective of the study is to assess whether the invasive cancer rate in the affected breast is the same for women undergoing standard care compared to surveillance. Secondary objectives will be to compare mastectomy rate, survival endpoints, and quality-of-life endpoints between standard care and surveillance groups.
The large randomized trial will compare operative to medical endocrine therapy for low-risk DCIS. The study plans to compare patients with low-risk DCIS who are randomized to receive either standard care or surveillance. Patients randomized to the standard care group will choose between currently recommended treatment options including surgery and radiation; those in the surveillance group will be monitored closely, with surgery or radiation only upon progression of disease. Patients in both the GCC and AS groups will be free to decide whether to choose endocrine therapy. Study participants will be recruited at 100 participating study sites during the 48-month recruitment period, with 446 patients to each study arm.
PCORI’s Board of Governors has approved more than $1.3 billion since 2012 in funding for 504 patient-centered comparative effectiveness studies and other projects to enhance the methods and infrastructure to support them.