NCT06736600

Patient-identified Values as Outcome Targets (PIVOT) Feasibility Pilot Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Neuropathy Due to Chemotherapy

Interventions

Type	Name	Description
BEHAVIORAL	Goal Attainment Scaling (GAS)	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

Timeline

• Start date: 2025-04-18
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2024-12-17
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States