This Mentored Research Scientist Development Award (K01) will facilitate the candidate's long-term career goal to be an independent investigator who will advance the research on the health impact of complementary behavioral interventions that are integrated into standard medical care of cancer patients (i.e., behavioral integrative interventions). Behavioral integrative interventions provide patients with skills they can use to reduce cancer-related symptoms during their daily lives. The candidate proposes to conduct clinical trials to evaluate such interventions and learn new methodology that captures how these interventions affect patients on a daily basis in their home environments and enables optimization of these interventions. The planned research focuses on investigating the impact of a behavioral integrative intervention (i.e., Yoga Skills Training; YST) that is implemented individually during chemotherapy on fatigue and depressive symptoms in patients diagnosed with colorectal cancer (CRC). CRC is the third most prevalent cancer in both men and women, fatigue is one of the most common and severe symptoms reported in CRC patients, and there are increasing numbers of CRC survivors. Fatigue frequently co-occurs with depressive symptoms, which are also common in CRC patients and may share underlying biobehavioral mechanisms (i.e., psychological stress, circadian disruption and inflammation). Fatigue and depressive symptoms follow a pattern such that they peak 3-5 days after chemotherapy and then improve, although not to baseline levels in a substantial subset of patients. In addition, symptoms experienced during treatment are related to subsequent symptoms. Despite this high symptom burden, there are few behavioral interventions designed for CRC patients to proactively improve fatigue and depressive symptoms during chemotherapy. Yoga, an intervention that combines psychological components (i.e., breathing practices, meditation) and gentle physical activity may be an optimal approach to reducing fatigue and depressive symptoms. Yoga has shown promise for improving fatigue, depressive symptoms, and biobehavioral mediators (i.e., psychological stress, circadian disruption and inflammation). Although research supports the efficacy of yoga when investigated in the group-class format primarily with breast cancer survivors, participants with high symptom burden and other cancer types are less likely to participate. Yoga has not yet been studied when implemented individually during chemotherapy to be more inclusive of patients with higher symptom burden or exclusively in patients with CRC. The planned study will build upon the candidate's previous research by piloting an improved randomized study of 60 patients undergoing chemotherapy for CRC with more robust measurements (i.e., daily assessment of symptoms, objective measure of circadian disruption, qualitative follow-up evaluation) and enhancement of the YST (i.e., more targeted to fatigue, attention to treatment fidelity, focused on adherence to home practice). This study aims to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures (Aim 1); to measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments (Aim 2); and to qualitatively assess perceived efficacy of the YST and AC and acceptability of new daily assessment methodology through semi-structured interviews in a subset of 20-40 participants (Aim 3). Through the mentored implementation of this research and complementary training activities, the candidate also aims to achieve the following short-term training goals: (1 to utilize technology to evaluate ecologically valid daily assessments of fatigue, depressive symptoms, circadian disruption and adherence to home practice and (2) methods (i.e., qualitative, yoga therapy techniques) to enhance the efficacy of behavioral integrative interventions. The candidate's complementary training activities are detailed in a career development plan that integrates this mentored research experience with the structured completion of coursework, attendance at seminars and meetings, publication of research, and gaining further experience in grant writing. Further, the candidate is currently in an especially strong environment that she is optimally utilizing to develop a novel program of behavioral integrative research. In summary, the proposed research is novel because it shifts the traditional paradigm from yoga taught to a group outside of the clinical setting to the individual during clinical care, which may reach patients with higher symptom burden. Further this study will utilize daily assessments of symptoms and adherence to home practice to understand the efficacy of the interventions when symptoms are at their worst. In addition, the daily fluctuation of symptoms experienced during chemotherapy is an ideal model for evaluating how self-regulation skills taught by the YST may improve patients' daily quality of life. Accomplishment of the proposed short-term training objectives will augment the candidate's career as an independent investigator who is uniquely qualified to advance the rigor of the study of behavioral integrative interventions for cancer patients.

Public Health Relevance

Behavioral interventions that combine physical activity and psychological components, such as yoga, may be optimal for improving the most common symptoms of cancer and its treatment. The proposed research is novel because it shifts the traditional paradigm from implementing yoga taught to a group outside of the clinical setting to the individual during clinical care with the aim of teaching patients skills they can use at home when symptoms are most burdensome. The proposed research and training will prepare the principal investigator to contribute methodological rigor to further investigation of behavioral interventions that will ultimately improve the daily quality of life of cancer survivors.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Scientist Development Award - Research & Training (K01)
Project #
7K01AT008219-02
Application #
9254035
Study Section
Special Emphasis Panel (ZAT1)
Program Officer
Mudd, Lanay Marie
Project Start
2016-04-01
Project End
2019-03-31
Budget Start
2016-04-01
Budget End
2017-03-31
Support Year
2
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
Addington, Elizabeth L; Sohl, Stephanie J; Tooze, Janet A et al. (2018) Convenient and Live Movement (CALM) for women undergoing breast cancer treatment: Challenges and recommendations for internet-based yoga research. Complement Ther Med 37:77-79
Sohl, Stephanie J; Dietrich, Mary S; Wallston, Kenneth A et al. (2017) A randomized controlled trial of expressive writing in breast cancer survivors with lymphedema. Psychol Health 32:826-842
Danhauer, Suzanne C; Addington, Elizabeth L; Sohl, Stephanie J et al. (2017) Review of yoga therapy during cancer treatment. Support Care Cancer 25:1357-1372
Sohl, Stephanie J; Avis, Nancy E; Stanbery, Kimberly et al. (2016) Feasibility of a Brief Yoga Intervention for Improving Acute Pain and Distress Post Gynecologic Surgery. Int J Yoga Therap :
Sohl, Stephanie J; Danhauer, Suzanne C; Birdee, Gurjeet S et al. (2016) A brief yoga intervention implemented during chemotherapy: A randomized controlled pilot study. Complement Ther Med 25:139-42
Sohl, Stephanie J; Birdee, Gurjeet S; Ridner, Sheila H et al. (2016) Intervention Protocol for Investigating Yoga Implemented During Chemotherapy. Int J Yoga Therap 26:103-111
Sohl, Stephanie J; Wallston, Kenneth A; Watkins, Keiana et al. (2016) Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study. Evid Based Complement Alternat Med 2016:3094589
Sohl, Stephanie J; Birdee, Gurjeet S; Ridner, Sheila H et al. (2016) Intervention Protocol for Investigating Yoga Implemented During Chemotherapy. Int J Yoga Therap :
Sohl, Stephanie J; Avis, Nancy E; Stanbery, Kimberly et al. (2016) Feasibility of a Brief Yoga Intervention for Improving Acute Pain and Distress Post Gynecologic Surgery. Int J Yoga Therap 26:43-47
Birdee, Gurjeet S; Sohl, Stephanie J; Wallston, Ken (2016) Development and Psychometric Properties of the Yoga Self-Efficacy Scale (YSES). BMC Complement Altern Med 16:3