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BackgroundAlthough patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to guide implementation of patient navigation in clinical practice. We characterize 8 patient navigation programs being implemented as part of multi-component interventions of the National Cancer Institute's Cancer Moonshot Accelerating Colorectal Cancer Screening and Follow-Up Through Implementation Science (ACCSIS) initiative.MethodsWe developed a data collection template organized by ACCSIS framework domains. The template was populated by a representative from each of the 8 ACCSIS research projects. We report standardized descriptions of 1) the socio-ecological context in which the navigation program was being conducted, 2) navigation program characteristics, 3) activities undertaken to facilitate program implementation (eg, training), and 4) outcomes used in program evaluation.ResultsACCSIS patient navigation programs varied broadly in their socio-ecological context and settings, the populations they served, and how they were implemented in practice. Six research projects adapted and implemented evidence-based patient navigation programs; the remaining projects developed new programs. Five projects began navigation when patients were due for initial colorectal cancer screening; 3 projects began navigation later in the screening process, when patients were due for follow-up colonoscopy after an abnormal stool-test result. Seven projects relied on existing clinical staff to deliver the navigation; 1 hired a centralized research navigator. All project researchers plan to evaluate the effectiveness and implementation of their programs.ConclusionsOur detailed program descriptions may facilitate cross-project comparisons and guide future implementation and evaluation of patient navigation programs in clinical practice.

There is a growing need for diversity, equity, and inclusion (DEI) in cancer care, particularly with respect to equal access and accrual to clinical trials. This commentary describe steps taken to address disparities in the authors' own clinical practice and proposes actions at the patient, provider, community, and institution levels to improve DEI in clinical trials. [ABSTRACT FROM AUTHOR]

Background: Lymphedema is an adverse effect of breast cancer treatment that causes swelling and pain in the arm and hand. We tested 2 lymphedema prevention interventions and their impact on health‐related quality of life (HRQOL) in a group‐randomized trial at 38 cooperative group sites within the United States. Methods: Patients were recruited before breast surgery. Sites were randomly assigned to education‐only (EO) lymphedema prevention or education plus exercise and physical therapy (LEAP). Lymphedema was defined as a ≥10% difference in arm volume at any time from baseline to 18 months postsurgery. HRQOL was assessed using the Functional Assessment of Cancer Therapy–Breast plus 4 lymphedema items (FACT‐B+4). Longitudinal mixed model regression analysis, adjusting for key demographic and clinical variables, examined participants' HRQOL by intervention group and lymphedema status. Results: A total of 547 patients (56% LEAP) were enrolled and completed HRQOL assessments. The results revealed no differences between the interventions in preventing lymphedema (P =.37) or HRQOL (FACT‐B+4 total score; P =.8777). At 18 months, the presence of lymphedema was associated with HRQOL at borderline significance (P =.0825). However, African American patients reported greater lymphedema symptoms (P =.0002) and better emotional functioning (P =.0335) than patients of other races or ethnicities. Lower HRQOL during the intervention was associated with younger age (P ≤.0001), Eastern Cooperative Oncology Group performance status >0 (P =.0002), ≥1 positive lymph nodes (P =.0009), having no education beyond high school (P <.0001), having undergone chemotherapy (P =.0242), and having had only axillary node dissection or sentinel node biopsy versus both (P =.0007). Conclusion: The tested interventions did not differ in preventing lymphedema or in HRQOL outcomes. African American women reported greater HRQOL impacts due to lymphedema symptoms than women of other races or ethnicities. Two tested lymphedema prevention interventions did not differ in prevention of lymphedema or in quality of life outcomes. African American women, however, reported more lymphedema symptoms than women of other races and ethnicities. [ABSTRACT FROM AUTHOR]

Background: Lymphedema affects many women who are treated for breast cancer. We examined the effectiveness of an education‐only (EO) versus education plus sleeve compression/exercise intervention (lymphedema education and prevention [LEAP]) on lymphedema incidence and range of motion (ROM) in a group‐randomized trial across 38 cooperative group sites. Methods: The treating institution was randomly assigned to either EO or LEAP by a study statistician. All patients at a treating institution participated in the same intervention (EO or LEAP) to minimize contamination bias. Participants completed surveys, arm volume measurements, and self‐reported ROM assessments before surgery and at 12 and 18 months after surgery. Lymphedema was defined as a ≥10% difference in limb volume at any time post‐surgery up to 18 months after surgery or diagnosis by a health provider. Cochran‐Mantel‐Haenszel tests were used to compare lymphedema‐free rates between groups, stratified by lymph node surgery type. Self‐reported ROM differences were compared between groups. Results: A total of 554 participants (56% LEAP) were included in the analyses. At 18 months, lymphedema‐free rates were 58% (EO) versus 55% (LEAP) (P =.37). ROM for both arms was greater in LEAP versus EO at 12 months; by 18 months, most women reported full ROM, regardless of group. In LEAP, only one‐third wore a sleeve ≥75% of the time; 50% performed lymphedema exercises at least weekly. Conclusion: Lymphedema incidence did not differ by intervention group at 18 months. Poor adherence in the LEAP group may have contributed. However, physical therapy may speed recovery of ROM. Further research is needed to effectively reduce the incidence and severity of lymphedema in patients who have breast cancer. Women in an exercise plus education group (lymphedema education and prevention [LEAP]) had faster return of full range of motion, but with no difference by intervention group in lymphedema incidence at 18 months. Poor adherence in the LEAP group may have contributed to similar lymphedema rates in the intervention groups; however, physical therapy may speed recovery of range of motion. [ABSTRACT FROM AUTHOR]

Cervical cancer incidence and mortality rates are disproportionally high among women living in Appalachia Ohio. This study used the Transtheoretical Model to examine screening barriers before and after a lay health advisor (LHA) intervention (2005–2009) to increase cervical cancer screening rates. Ohio Appalachian women (n = 90) who were in need of a Pap test, based on risk-appropriate guidelines, were randomized to a 10-month LHA intervention and received two in-person visits, two phone calls, and four mailed postcards targeted to the participant’s stage of change. Findings revealed that 63% had forward stage movement 10 months after the intervention. The most frequently reported screening barriers were time constraints, forgetting to make an appointment, and cost. Women who reported the following barriers—doctor not recommending the test; being unable to afford the test; and being embarrassed, nervous, or afraid of getting a Pap test—were less likely to be in the action stage. Understanding the stages of change related to Pap testing and reported barriers among this underserved population may help inform researchers and clinicians of this population’s readiness for change and how to set realistic intervention goals. [ABSTRACT FROM PUBLISHER]