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

NCT06736600 | Recruiting DMC

• 2 other identifiers: 2024-1305NCI-2024-10309
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Goal Encouragement

EXPERIMENTAL

Eligible participants will be identified using electronic health record

Behavioral: Goal Attainment Scaling (GAS)

No Goal Encouragement

EXPERIMENTAL

Eligible participants will be identified using electronic health record

Behavioral: Goal Attainment Scaling (GAS)

Interventions

Goal Attainment Scaling (GAS) BEHAVIORAL

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

Goal Encouragement; No Goal Encouragement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

Study Officials

• Alice Ye, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Ye, MD

CONTACT

713-745-2933; alye@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: April 18, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)