Siobhan M. Phillips, Ph.D. - US grants

DESCRIPTION (provided by applicant): There are over 2.4 million breast cancer survivors (BCS) in the U.S. accounting for 22% of all cancer survivors [1]. The 5-year survival rate of 88.6% [1] coupled with a 1 in 8 lifetime chance of a breast cancer diagnosis [2] has resulted in an increasingly growing population with distinct public health needs resulting from side effects associated with current available treatments [3]. In addition, BCS are at an increased risk of cancer recurrence, comborbidites, premature death and decreased quality of life (QOL) [4-6]. Physical activity (PA) has been identified as a lifestyle factor with excellent potential for ameliorating the aversive side effects of treatment and positively influencing disease-related outcomes [7, 8]. However, only 1/3 of BCS meet the current public health guidelines for PA [9, 10]. Identifying factors influencing PA participation and how PA is related to QOL in BCS is important for developing effective interventions which can be translated into practice. This project will adopt a prospective design to test the full Social Cognitive Theory (SCT) model for explaining PA in BCS over the course of a 6-month period. Previous research has used individual elements of SCT to understand and predict PA behavior in the general population [11-13], but the full model has yet to be tested, particularly in BCS. The proposed study will include measures to test the full SCT: self-efficacy, goals, outcome expectations, sociocultural factors (facilitators and impediments), and PA behavior [14]. PA has also been shown to positively influence QOL in BCS [7, 8]. However, very little research has been conducted to explain this relationship. Thus, the proposed study will also include measures to test the PA and QOL model proposed by McAuley and colleagues [15] in BCS. This model proposes PA influences global QOL indirectly through its effects on self-efficacy and health related QOL (physical and mental health) whereby self-efficacy is both directly and indirectly related to global QOL through its effect on health related QOL. The public health significance of this study lies in its potential to develop an improved, theoretically sound understanding of PA behavior in BCS as well as a better understanding of the relationship between PA and QOL. These findings could potentially result in better designed, more effective PA programs for BCS which ultimately has the potential to reduce healthcare costs associated with cancer recurrence, comorbidities, and premature death in BCS.

PROJECT SUMMARY/ABSTRACT Increased moderate-to-vigorous intensity physical activity (MVPA) is associated with reductions in treatment- related side effects, cancer recurrence and mortality, and increased QOL in breast and endometrial cancer survivors. However, the majority (~70%) of survivors do not meet cancer-specific MVPA recommendations (i.e., 150 mins/week). MVPA support is not part of standard care, resulting in few survivors having access to efficacious MVPA programs. Failure to translate MVPA programs into care is a result of most interventions being intense, on-site programs that deliver multiple components simultaneously to all participants. This ?one- size-fits-all? approach does not account for individual needs, nor can it realistically be implemented into survivorship care. mHealth tools (i.e. smartphone applications, Fitbits, text messages), are inexpensive and have demonstrated efficacy for increasing MVPA in other populations. Thus, they may be a more scalable, less resource-intensive strategy to increase MVPA in more survivors. The ability to integrate wearable MVPA monitor data into the electronic health record (EHR) further enhances the potential for a technology-supported MVPA intervention to be integrated into cancer care. However, responses to these tools are heterogeneous and may vary as part of a gradually progressing (in terms of weekly goal mins) MVPA program and their effects on morbidity indicators is unknown. While a minimal intervention including the Fitbit integrated into the EHR (Fitbit+EHR) may be sufficient for some cancer survivors to increase their MVPA, others will need more support. Further, some survivors may need this additional support early on, while others may succeed early, but fail later when the MVPA goal increases. Evidence is lacking to determine: a) whether the best augmentation tactic for increasing MVPA in non-responders is to offer another mHealth component (i.e. online exercise videos) alone or with a more traditional component (i.e., telephone coaching) and b) what the best adaptive intervention is to improve morbidity indicators. Thus, we propose to utilize a novel adaptive intervention design to determine the optimal: 1) augmentation component(s) to address non-response and 2) adaptive intervention for improving morbidity indicators (i.e., symptom burden and functional performance). Inactive breast and endometrial cancer survivors (n=320) will receive a Fitbit integrated into the EHR (Fitbit+EHR). Those who do not respond to the Fitbit+EHR intervention as evidenced by failure to sufficiently increase their MVPA will be re-randomized to one of two subsequent augmentation tactics, either: (1) online gym or (2) online gym and coaching calls. Responders will continue with the Fitbit+EHR for 6 months. The project is significant because it aims to develop an effective and scalable MVPA intervention for cancer survivors that will move from a one-size-fits-all approach to a dynamic, tailored approach for MVPA promotion by identifying non-responders at the right time and providing them with the additional intervention components necessary to increase MVPA and improve health and disease outcomes.

PROJECT SUMMARY/ABSTRACT There are approximately 680,000 adolescent and young adult cancer survivors (AYACS) in the U.S., and the survival rate in this group is increasing. AYACS experience a myriad of deleterious treatment-related side effects, higher rates of physical and emotional problems and are at a heighted risk of early morbidity and mortality compared to non-cancer age-matched controls. Increased moderate to vigorous intensity physical activity (MVPA) is consistently associated with enhanced quality of life (QOL), reduced cancer treatment- related side effects and chronic disease risk, and improved cancer prognosis in cancer survivors. Yet, the majority of AYACS (~60%) do not meet cancer-specific MVPA recommendations (i.e., 150 mins/week), and very little research on MVPA in cancers survivors has focused specifically on AYACS. Existing studies of MVPA in survivors are largely resource-intensive, costly, and deliver multiple components (i.e., coaching calls, supervised exercise) simultaneously limiting scalability. Three evidence-based strategies have been identified that may be particularly useful for overcoming these barriers and increasing MVPA in AYACS: 1) electronic delivery of a MVPA program, 2) social support, and 3) mindfulness training. However, little is known on the unique roles of social support and mindfulness in MVPA promotion. More granular information about the discrete effects of these components is needed to optimize intervention configuration in order to maximize an effective and scalable MVPA program for AYACS. The purpose of this study is to apply the Multiphase Optimization Strategy (MOST), to determine which types of social support and mindfulness training intervention components optimally increase MVPA in a 12-week mHealth MVPA intervention with a 12 week follow-up. MOST is a framework adapted from engineering that uses highly efficient factorial experiments to evaluate individual, and combined, effects of intervention components to determine which ones can be reduced, eliminated or replaced to improve efficiency. Inactive AYACS (n=304) will receive a core intervention consisting of the OPTIMAL AYAO app and Fitbit and be randomly assigned to 4 components under consideration for inclusion in the optimized intervention: 1) general mindfulness training; 2) MVPA specific mindfulness training; 3) e-coach and 4) engagement of a buddy. We will also examine the effects of increasing MVPA on symptom burden, intensities of other activities (i.e. light and sedentary), and sleep quality and duration and potential mediators and moderators of component effects. The proposed study represents the first systematic effort to use MOST to design an optimized, scalable mHealth MVPA intervention for AYACS. This study will lead to an improved understanding of how to effectively change AYACS' MVPA and ultimately, improve health and disease outcomes in this population.