By 2030, cancer will surpass heart disease as the leading cause of death in the United States. These patients are likely to experience the burden of unmanaged symptoms resulting from cancer and its treatment,1-3 leading to diminished health related quality of life (HRQOL).4-8 Solid tumors carry their own set of symptoms. In order to optimize symptom management, there must be a shift from fixed interventions one size fits all to adaptive interventions tailored to individual patients. This shift requires research on how to best arrange previously tested single fixed interventions into sequences and how to best operationalize the decision rules for switching from one intervention to another for individual patients. Our team's work to date with breast and lung cancer patients has shown efficacy for two home-based symptom management interventions, reflexology and meditative practices, delivered by or with friend or family caregivers. The proposed multi-staged interventions will be developed using the sequential multiple assignment randomized trial (SMART) design. The sustainability of use of these two evidence-based therapies and improvements in symptom outcomes will be tested during weeks 5-8 and at the week 12 follow-up of 331 patients based on power analysis, against a control group.
The specific aims are:
Aim 1. To compare the reflexology and meditative practices groups weeks 1-4 (1st intervention stage) on the primary outcome of fatigue severity and 3 secondary symptom outcomes: a single summed score from the MD Anderson symptom inventory, depressive symptoms, & anxiety, so as to determine: a) the relative effectiveness of these therapies; and b) the characteristics of responders and non-responders to each therapy.
Aim 2. Among patients who do not respond to reflexology on fatigue during the first intervention stage, to determine the value added by meditative practices during weeks 5-8 (2nd intervention stage) vs continuing with reflexology alone for severity of fatigue and the 3 secondary symptom outcomes.
Aim 3. Among patients who do not respond to meditative practices on fatigue during the first intervention stage, to determine the value added by reflexology during weeks 5-8 (2nd intervention stage) vs continuing with meditative practices alone for severity of fatigue and the 3 secondary symptom outcomes.
Aim 4. To compare improvements in fatigue severity and the 3 secondary symptom outcomes among two groups that received intervention sequences and the control group.
Aim 5. To explore which dyadic characteristics observed during the first intervention stage are associated with optimal patient symptom outcomes during the 2nd intervention stage and week 12 follow-up, so as to determine tailoring variables for the decision rules of sequencing future intervention stages. By sequencing two evidence-based interventions, the proposed research will impact research and practice by determining how to maximize the benefit of symptom management during cancer treatment.

Public Health Relevance

Cancer-related symptoms represent a major public health concern and burden, and many cancer patients experience unmanaged symptoms. The proposed study will test the sustainability of two evidenced-based complementary therapies using the sequential management assignment randomized trial (SMART) design. This research has the potential to impact research and practice by determining how to maximize the benefit of symptom management during cancer treatment.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA193706-04
Application #
9600659
Study Section
Nursing and Related Clinical Sciences Study Section (NRCS)
Program Officer
O'Mara, Ann M
Project Start
2015-12-08
Project End
2019-11-30
Budget Start
2018-12-01
Budget End
2019-11-30
Support Year
4
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Michigan State University
Department
Type
Schools of Nursing
DUNS #
193247145
City
East Lansing
State
MI
Country
United States
Zip Code
48824
Sikorskii, Alla; Wyatt, Gwen; Lehto, Rebecca et al. (2017) Using SMART design to improve symptom management among cancer patients: A study protocol. Res Nurs Health 40:501-511
Leonenko, N N; Papi?, I; Sikorskii, A et al. (2017) Heavy-tailed fractional Pearson diffusions. Stoch Process Their Appl 127:3512-3535