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

Launched by M.D. ANDERSON CANCER CENTER · Dec 12, 2024

Keywords

ClinConnect Summary

The PIVOT Feasibility Pilot Trial is a research study designed to help patients with chemotherapy-related nerve damage, known as peripheral neuropathy, focus on what matters most to them in their care. This trial aims to shift the way healthcare is delivered, moving from just treating the disease to considering the whole person and their individual values. The study is not yet recruiting participants, but it will involve people aged 18 and older who live in the Houston area and have experienced significant pain or bothersome symptoms from their condition.

To participate, individuals must have access to a smartphone and the internet, be able to attend an in-person appointment at the Main Hospital Pain Management Clinic within a few weeks, and be comfortable communicating in English. Participants can expect to engage in a technology-based program that helps them identify their personal health goals and needs. This trial is an exciting opportunity for patients to take an active role in their care while receiving support tailored to their unique experiences.

Gender

ALL

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