Joanna J. Arch, Ph.D. - US grants

PROJECT ABSTRACT This project will develop and pilot a brief, novel personal values-based intervention for promoting adherence to endocrine therapy (daily anti-hormonal medication) among breast cancer survivors. Endocrine therapy (ET) represents the most powerful way to prevent recurrence of the most common form of breast cancer (estrogen receptor-positive)1,2, cutting recurrence rates by 40-50%3,4, and breast cancer survivors who adhere to it live longer5,6. Although ET is generally prescribed once daily for five to ten years7,8, only half or fewer breast cancer survivors adhere to it as recommended6,9,10. Yet a recent Cochrane review11 identified no effective medication adherence interventions that were sustainable for community settings and found that only 1 of 182 trials focused on a cancer population, revealing a lack of disseminable approaches to promote ET adherence. By developing a low-cost, disseminable intervention to improve ET adherence, this project addresses this vital need11,12. In addition to educating patients on ET benefits and encouraging them to discuss side effects with providers, the proposed intervention innovatively links the medical value of ET adherence with patients' personal values (who and what are most important to them). Using piloted prompts to elicit values linked to taking ET, we will create a sticker with an image that captures each patient's top value (e.g., photo of grandkids, family, travel) and have patients attach this sticker to their ET medication box, creating an affective visual cue for promoting ET adherence. The intervention thus aims to create more positive and meaningful associations with ET, addressing a core set of risk factors for ET non-adherence13. Values comprise a central component of a theory-driven model for promoting behavior change and reducing psychological distress14,15, which we adapted to reduce distress among cancer survivors16 and which has been applied to change multiple health behaviors17-21. We propose to conduct the first study that applies values to improving ET medication adherence. The pilot will be conducted in collaboration with a statewide community oncology pharmacy, readying it for dissemination. We aim to: (1) Develop and refine the brief values intervention in response to patient (n = 10) and medical team (n = 5) feedback; (2) Conduct a pilot randomized trial (n = 80) among breast cancer survivors recently prescribed ET to preliminarily evaluate whether the values intervention (plus ET education), improves ET adherence (with electronic pillbox monitoring as primary outcome), positive and negative emotional associations with ET, and intentions to adhere to ET in the next 1 and 5 years, compared to an education-only control, and to assess intervention acceptability and evaluate the feasibility of a large-scale trial; (3) Revise intervention content in response to participant feedback, analyze data, and use findings to inform next steps. Given the life-extending benefits of ET5,6 coupled with the lack of brief, sustainable interventions designed to promote ET adherence11 the development, refinement, and piloting of this intervention has the potential to benefit both breast cancer survivors and the healthcare system. !

PROJECT ABSTRACT This randomized clinical trial will evaluate a novel, piloted, primary palliative care intervention that addresses the lack of advance care planning and psychosocial needs commonly experienced by patients with metastatic cancer.1-8 Up to half of adults with metastatic cancer report elevated anxiety or depression (anx/dep),6,11,12 which can cause withdrawal from daily activities and future planning.13,14 The intervention focuses on patients with elevated anx/dep symptoms?those with highest psychosocial needs who may be at greatest risk for advance care planning non-completion. The intervention is founded on an evidence- based intervention approach known as Acceptance and Commitment Therapy (ACT)11,12 that reduces distress and promotes behavior change through theory-driven mechanisms. 13-17 In a single arm pilot study for adults with metastatic cancer and elevated anx/dep symptoms, we leveraged ACT to design and refine the multi- modal ACT intervention (M-ACT). M-ACT helps patients to live meaningfully and face the future no matter what their health status, including completing advance care planning. In our single-arm pilot study,18 M-ACT was highly rated by patients and was associated with significantly increased advance care planning completion and sense of meaning, and decreased anx/dep symptoms and fear of dying. To increase scalability, M-ACT uses a multi-modal delivery structure that integrates in-person group sessions with online sessions completed at home. Group sessions connect patients to learn in-person together whereas online sessions expand on the skills learned within groups, increasing intervention dose without increasing patient travel or healthcare resource demands. In the proposed randomized trial, we will rigorously compare M-ACT to a usual care control condition. We will also leverage the trial to assess the association between advance care planning and anx/dep symptoms, thereby informing the critical practice question of whether anx/dep symptoms should be addressed concurrently with advance care planning. The proposed study will enroll patients with Stage IV solid tumor cancer (N=240) within the same community-based cancer care network as the pilot study, randomized 1:1 to M-ACT or usual care. We aim to: 1) Evaluate the hypothesis that M-ACT will increase advance care planning completion (primary outcome) and sense of life meaning, and reduce anx/dep symptoms and fear of dying relative to usual care control. 2) Assess the association between anx/dep symptoms and advance care planning at baseline and over time, testing the hypothesis that decreases in anx/dep symptoms at post- intervention will be associated with increases in advance care planning at follow-up. 3) Assess M-ACT's hypothesized mechanisms to specify how the intervention works (exploratory aim). Given their advance care planning and psychosocial needs, and poor access to palliative care, rigorously investigating M-ACT has the potential to benefit community patients with metastatic cancer and to advance palliative care science by addressing gaps in novel approaches, foundational knowledge, and the scalable delivery of palliative care. !