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Randomized controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (i.e., all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated. Here, we describe CONSORT Harms 2022, which replaces the CONSORT Harms 2004 checklist, and shows how CONSORT Harms 2022 items could be incorporated into the main CONSORT checklist. Thirteen items from the main CONSORT were modified to improve harms reporting. Three new items were added. In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist and elaborate on each item relevant to complete reporting of harms in randomized controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomized controlled trials should use the integrated checklist presented in this paper.

Breast cancer remained a hidden disease among women in the United States until the 20th century. It was initially brought into the open with public revelations from individual women, which was followed by the development of support groups and ultimately the formation of political activist groups with various priorities. Those concerned with toxic environmental exposures as a potential cause of breast cancer organized, demonstrated, and lobbied for research funding and eventually became partners in the research that arose from their efforts. One representative example was the Breast Cancer and Environment Research Centers (BCERC) Project (2003–2010), supported by the National Institute of Environmental Health Sciences (NIEHS) and the National Cancer Institute (NCI). The BCERC embedded a Community Outreach and Translational Core into its formal organizational infrastructure to ensure advocate involvement in the standing scientific subcommittees of BCERC, the first project funded by NIEHS and NCI to do so. The formal integration of advocates as partners in scientific studies focused on breast cancer is embedded in a rich history of action on the part of many courageous women. This article describes the historical evolution of breast cancer activism in the United States, which provided a critical foundation for the formation of BCERC. This description is followed by a discussion of BCERC as an example of the transdisciplinary research model, a paradigm that strives for inclusion of multiple stakeholders and increased interaction between scientists from a wide spectrum of disciplines, advocates, and lay audiences in order to more effectively conduct critical research and to translate and disseminate its findings.

e273 Background: As patient advocates we have spent years gathering and sharing information about simple, natural strategies to reduce risk of treatment-related toxicities and strengthen the immune system in survivorship. Sadly it is well known that many suffer long-term toxicities and are at higher risk for secondary cancers. Survivorship plans are created to help people move forward with their lives; we suggest the “3 Steps 4 Health” program as an addition. Methods: We created a simple 3-step program that absolutely anyone with cancer can incorporate into their own healthful protocol as they move into complete recovery. Since it involves no tools and can be used at the level that an individual is at the time they start, we consider it appropriate for all. Further, we cannot see any objection from the oncologist or staff members. Step 1: Eat one more fruit and one more vegetable every day. This is helpful since studies show few Americans are getting enough fruits or vegetables. The National Cancer Institute considers “Five a Day” a minimum. We want to get people started on the correct path simply and easily. Step 2: Take a walk around the room or neighborhood depending on ability and health status. This has been shown by many studies to help anyone with cancer, undergoing treatment, or in recovery. We are not asking people to become athletes; we are involving them in a plan to improve their health. Step 3:Seven deep breaths in a stressful situation or at bedtime. This step is important to reduce stress and encourage relaxation. Results: As patient advocates, we conduct no research; we scour journals for studies supporting our evidence-based concept. There are now many studies showing the value of one or more of the three steps. Rarely does research examine the concept as a whole. We believe this will occur soon. Conclusions: Every step moves people forward into better health. We believe taking these first steps will lead to more healthful behaviors, better ability to handle conventional cancer treatments, and an easier recovery. In this era of interest in immune response, it makes perfect sense for each individual to strive to be their personal best. Clearly, the “3 Steps 4 Health” program is a beginning at an important time for those who have survived cancer. We will share some of the studies that led us to this position.

95 Background: As Patient advocates we have spent years gathering/ sharing information about simple, natural strategies to reduce risk of cancer treatment-related toxicities and strengthen the immune system. Methods: We created a simple 3 step program that absolutely anyone with cancer, at any stage, can incorporate into their own healthful protocol. Since it involves no tools and can be used at the level that an individual is at the time they start, we consider it appropriate for all. Further we cannot see any objection from the Oncologist or staff members. Step 1 is eating one more fruit and one more vegetable every day. This is helpful since studies show few Americans are getting enough fruits or vegetables. The National Cancer Institute considers ‘Five a Day’, a minimum. We want to get people started on the correct path simply and easily. Step 2 is taking a walk around the room, facility or neighborhood depending on ability and health status. This has been shown by many studies to help anyone with cancer, undergoing treatment or in recovery. We are not asking folks to become athletes; we are involving them in a plan to improve their health. Step 3: 7 deep breaths before treatment, in a stressful situation or at bedtime. This step is important to reduce stress and encourage relaxation. Results: Every step moves people forward into better health. We believe taking these first steps will lead to more healthful behaviors, better ability to handle conventional cancer treatments, and an easier recovery. Conclusions: Immune system health depends on the individual as much as any treatments. In this era of Immunology, we see a real opportunity for our Patient/Advocate-driven concept.

133 Background: As a 20+ year breast cancer survivor I sought to find and offer information on natural cancer strategies. At first I needed them for my own cancer protocol, then to help others Integrative Oncology refers to the simple, natural and non-toxic approaches that can reduce toxicity, possibly enhance the efficacy of conventional treatment, and create feelings of well-being and control in people dealing with cancer. Many studies, some from long ago, have pointed to the strong patient interest in Integrative Oncology (formerly known as CAM). Yet the professional oncology community’s knowledge has failed to keep up. Trained to seek level 1 studies, they have failed to note the preponderance of all the other evidence available supporting natural approaches. Due to cost, most natural products/substances are not reviewed at level 1 and probably will never be. Methods: We’ve created a simple program we call 3 Steps 4 Health, which offers anyone in cancer treatment a guide to improved health. We will present the research that backs up these simple ideas that can be incorporated into anyone’s protocol. We also have a handout to reduce toxicities that is evidence-based to help with those adverse effects that plague modern cancer patients. So many suffer from neuropathy – there are quite a few methods to protect or treat this with complementary therapies that can be integrated into conventional treatment. Results: ASCO has pointed to the value of Yoga, of ginger, and other natural approaches but oncology professionals have been slow to adopt or recommend. Conclusions: We will provide evidence-based information on integrative oncology and the 3 Steps 4 Health program.