RECRUITING

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

Conditions

Peripheral Neuropathy Due to Chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-18

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06736600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	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	* 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

Inclusion Criteria

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

* 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

Contacts and Locations

Study Contact

Alice Ye, MD

CONTACT

713-745-2933

alye@mdanderson.org

Principal Investigator

Alice Ye, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Alice Ye, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-18

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2025-04-18

Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

Peripheral Neuropathy Due to Chemotherapy