Abstract Content:

Significance: Complementary Alternative Medicine (CAM) is used by 60-80% of individuals with cancer. Well-conducted CAM research is needed to inform nursing practice. To date many CAM research findings have been inconsistent due to design and methodological issues.

Purpose: The purpose of this paper is to outline key design and methodological issues related to securing National Institutes of Health (NIH) funding for complementary therapy research.  From the perspective of both a RO1 funded CAM investigator and reviewer, specific criteria will be shared.

Conceptual Framework: The Wyatt Quality of Life Framework will be utilized as an exemplar.

Design: The design prototype is a 3-group longitudinal randomized clinical trail (RCT). The design allows for efficacy testing and dose confirmation.

Sample: The sample will address a well-powered RCT. The sample size considerations are based on having adequate power to detect medium effect sizes in the comparison of the means of outcome measures across three groups.

Methods and Analysis: The specific areas that will be covered include: three group design to detect the effect of the protocol dose of the complementary therapy compared to standard care control and placebo control; randomization with computer minimization on key variables to assure equivalence of three groups at baseline with respect to these variables; sequencing of specific aims to perform pair-wise comparisons of the groups; adjusting for relevant covariates in the analyses; addressing the issue of multiple correlated outcomes; and ways to strengthen the intervention protocol for both the complementary therapy and placebo.

Findings/Implications: These design decisions will contribute to researcher's ability to conduct complementary therapy research that will inform and translate to oncology-nursing practice.

Discussion: The specific areas outlined in this abstract are intended to increase an investigator's likelihood of NIH funding.