There are currently over 3.1 million breast cancer survivors, and these numbers are projected to increase over the next decade. Although the growing number of breast cancer survivors may reflect advances in detection and treatment, the transition to post-treatment survivorship remains challenging. Patients are left with sequelae due to their cancer diagnosis and treatment resulting in impairments in quality of life (QOL) and an ongoing burden from cancer. Few safe and effective approaches currently exist to address this gap in care. We have developed and piloted a personalized and patient centered Integrative Medicine (IM) intervention based on Ayurvedic Medicine, which includes diet, lifestyle, yoga, and pressure point treatment, for breast cancer survivors. In a single arm prospective clinical study of this four month IM intervention, in a sample of breast cancer patients who were within the first year after completing treatment for localized breast cancer, we were able to demonstrate feasibility in this patient population and found large effect sizes for improvements in QOL and associated symptoms. The effects of the intervention had not plateaued at the end of the four month intervention period and qualitative data indicated that patients would have preferred a longer and more intensive intervention. We propose to conduct key next steps in intervention development in anticipation of testing this intervention in a large-scale randomized controlled trial (RCT) to follow: 1) To develop, iteratively refine, and test the feasibility of a ix month Ayurvedic IM intervention for breast cancer survivorship; 2) To develop, iteratively refine, and test the feasibility of a six month attention control (AC) condition for future use in an RCT; and 3) To test the feasibility of randomization, adherence, and retention of the final Ayurvedic IM intervention and the AC. We propose an iterative and adaptive approach for the optimization of an Ayurvedic IM intervention for breast cancer survivorship and the development of an AC followed by pilot testing of the randomized study design in anticipation of conducting a large-scale RCT to follow.
In Aim 1 and 2 we will test two iterations of the six month Ayurvedic IM intervention (N=10+10) and AC (N=10+10) with intervention development in between iterations. The final Ayurvedic IM intervention and AC will then be tested in a pilot RCT (N=30) (Aim 3). The initial results from our prior study are promising and taking these incremental next steps in this work will be essential to definitively evaluating whether this approach can improve the QOL of survivors. In the long-term, if this approach is shown to be effective, it has the potential to shift the paradigm in favor of emphasizing the importance of addressing symptoms and quality of life, the development of non-toxic and natural approaches for health, and a more patient-centered focus in healthcare.
Despite improved survival, the short and long-term complications of breast cancer and its treatment result in significant impairments in quality of lie leading to an ongoing burden of cancer in these patients. We developed and piloted a personalized patient-centered Integrative Medicine intervention based on Ayurvedic Medicine that includes advice on diet, lifestyle, and yoga for breast cancer patients who had recently completed cancer treatment and found that this intervention helped patients by addressing the residual symptoms caused by cancer treatment and improved their quality of life. We now propose to expand on this work by evaluating ways to make the Ayurvedic Integrative Medicine intervention easier to incorporate into patients' lives and to continue to improve its favorable impact on symptoms and quality of life.