Background:Mindfulness-Based Interventions (MBIs) have been shown to improve mental and physical health as well as biological processes of patients living with cancer. More research is needed to inform on the determinants that might facilitate or hinder their implementation in hospitals. The primary objective of this study was to explore the feasibility and implementation of an online Mindfulness-Based Cancer Recovery program (e-MBCR) for women with breast and gynecological cancer treated at two academic oncology centers in Switzerland. The secondary objective was to explore the psychological and biological effects of the program.Methods:The SERENITY study is a pilot hybrid effectiveness-implementation trial using a randomized waitlist-controlled design, including a mixed methods approach. The intervention groups receive treatment as usual and the e-MBCR program, whereas the control groups are on a wait-list to receive an online Mindfulness-Based Stress Reduction program at the end of the study. Four e-MBCR programs are delivered consecutively, with 12 patients in each group. Participants' attendance to the sessions is the primary outcome. Implementation outcomes of interest are feasibility, acceptability, appropriateness, fidelity, costs, and early sustainability. Implementation determinants will be described, and an exploratory analysis of psychological outcomes and cancer-related biomarkers will be performed at three time points (baseline, postintervention, and 3 months of follow-up).Discussion:The results of this study will inform a future large trial and adjustments needed for a real-world implementation of the program. The translational part of this study will contribute to the collective effort to better understand how MBIs affect important cancer-related biomarkers.
<div>Abstract<p>Developing strategies to inflame tumors is critical for increasing response to immunotherapy. Here, we report that low-dose radiotherapy (LDRT) of murine tumors promotes T-cell infiltration and enables responsiveness to combinatorial immunotherapy in an IFN-dependent manner. Treatment efficacy relied upon mobilizing both adaptive and innate immunity and depended on both cytotoxic CD4<sup>+</sup> and CD8<sup>+</sup> T cells. LDRT elicited predominantly CD4<sup>+</sup> cells with features of exhausted effector cytotoxic cells, with a subset expressing NKG2D and exhibiting proliferative capacity, as well as a unique subset of activated dendritic cells expressing the NKG2D ligand RAE1. We translated these findings to a phase I clinical trial administering LDRT, low-dose cyclophosphamide, and immune checkpoint blockade to patients with immune-desert tumors. In responsive patients, the combinatorial treatment triggered T-cell infiltration, predominantly of CD4<sup>+</sup> cells with Th1 signatures. Our data support the rational combination of LDRT with immunotherapy for effectively treating low T cell–infiltrated tumors.</p>Significance:<p>Low-dose radiation reprogrammed the tumor microenvironment of tumors with scarce immune infiltration and together with immunotherapy induced simultaneous mobilization of innate and adaptive immunity, predominantly CD4<sup>+</sup> effector T cells, to achieve tumor control dependent on NKG2D. The combination induced important responses in patients with metastatic immune-cold tumors.</p><p><i>This article is highlighted in the In This Issue feature, p. 1</i></p></div>
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