A behavioral trial aimed at helping patients identify what matters most to them and is part of a larger effort to pivot from disease-oriented care to whole-person care.
Primary Objectives: The primary objective of the pilot clinical trial is to evaluate feasibility, operationalized as attrition, acceptability, and adherence rates of the GAS measure. Secondary Objectives: To evaluate initial efficacy across both arms (pre-post comparison) and between arms (A-B comparison) of goal encouragement. Due to the pilot nature of this work and a lack of published effect size estimates, this trial is unlikely to be adequately powered to estimate true efficacy. However, this trial will provide a rich source of preliminary data and effect size estimates that can be utilized to conduct formal power analysis for a larger efficacy trial. The tertiary objective will be to identify themes within the GAS measures created by participants, utilizing grounded theory inductive coding of themes into broader categories, and comparing against the common categories pre-identified within the Patient Priorities Care framework. The quaternary objective will be to assess a novel measure of CIPN outcomes called the Individual Neuropathy Report Card against current common CIPN measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
45
Goal-setting tele-coaching and the well-studied Patient Priorities Care framework will assist participants with bothersome CIPN identify their most important health goals and scale them into specific, measurable, achievable, relevant, and time-bound (SMART) goals
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSafety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year
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