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

NCT ID: NCT06736600

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-18
• Study Completion Date: 2027-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Goal Encouragement

Eligible participants will be identified using electronic health record

Group Type: EXPERIMENTAL

Goal Attainment Scaling (GAS)

Intervention Type: 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

No Goal Encouragement

Eligible participants will be identified using electronic health record

Group Type: EXPERIMENTAL

Goal Attainment Scaling (GAS)

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice Ye, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alice Ye, MD

Role: CONTACT

Phone: 713-745-2933

Email: alye@mdanderson.org

Facility Contacts

Alice Ye, MD

Role: primary

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2024-10309

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1305

Identifier Type: -

Identifier Source: org_study_id