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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Neuropathy Due to Chemotherapy
• Intervention / Treatment: Behavioral: Goal Attainment Scaling (GAS)

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas M. D. Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated electronic informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Age 18 or older.
• Documented diagnosis of chemotherapy-induced peripheral neuropathy meeting the following criteria: 1) onset associated with timing of neurotoxic chemotherapy and 2) symptomatic reports of peripheral neuropathy.
• Access to smartphone and internet for participating in a technology-based intervention
• Upcoming in-person appointment in the Main Hospital Pain Management Clinic 4-6 weeks from the consent date.
• English-speaking
• Pain or bothersome symptoms present most days of the week at an average of ≥4/10 on the Numeric Rating Scale for the past 3 months
• No longer receiving cancer treatment or has been on stable maintenance treatment for the past 3 months.
• Resides in the Houston Metroplex
• A score ≤7 on the validated Six Item Cognitive Impairment Test (6CIT) for unimpaired cognition

Exclusion Criteria:

• Provision of signed and dated electronic informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Age 18 or older.
• Documented diagnosis of chemotherapy-induced peripheral neuropathy meeting the following criteria: 1) onset associated with timing of neurotoxic chemotherapy and 2) symptomatic reports of peripheral neuropathy.
• Access to smartphone and internet for participating in a technology-based intervention
• Upcoming in-person appointment in the Main Hospital Pain Management Clinic 4-6 weeks from the consent date.
• English-speaking
• Pain or bothersome symptoms present most days of the week at an average of ≥4/10 on the Numeric Rating Scale for the past 3 months
• No longer receiving cancer treatment or has been on stable maintenance treatment for the past 3 months.
• Resides in the Houston Metroplex
• A score ≤7 on the validated Six Item Cognitive Impairment Test (6CIT) for unimpaired cognition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goal Encouragement; Eligible participants will be identified using electronic health record	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
Experimental: No Goal Encouragement; Eligible participants will be identified using electronic health record	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety 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	Through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Alice Ye, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 2024-1305; NCI-2024-10309 (Other Identifier: Clinical Trials Reporting Program (CTRP))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No