PIVOT — helping people with chemotherapy-related neuropathy set personal outcome goals
Patient-identified Values as Outcome Targets (PIVOT) Feasibility Pilot Trial
This pilot tests a Goal Attainment Scaling program delivered by smartphone to help adults with chemotherapy-induced peripheral neuropathy identify and work toward personal health goals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06736600 on ClinicalTrials.gov |
What this trial studies
This is a feasibility pilot using Goal Attainment Scaling (GAS) to help adults with chemotherapy-induced peripheral neuropathy define and pursue personally meaningful outcomes. Participants must have smartphone/internet access, be English-speaking, and live in the Houston Metroplex with an upcoming pain clinic visit; the trial measures attrition, acceptability, and adherence to the GAS measure. The design includes pre-post and between-arm comparisons of goal encouragement to gather preliminary effect-size data and inform a larger trial. The study will also code themes from participant-created GAS goals and compare a new Individual Neuropathy Report Card against common CIPN measures.
Who should consider this trial
Good fit: Adults (≥18) with chemotherapy-induced peripheral neuropathy who report bothersome symptoms most days (average ≥4/10 for 3 months), are English-speaking, have smartphone and internet access, score ≤7 on the 6CIT, are not actively receiving cancer therapy (or on stable maintenance ≥3 months), and reside in the Houston Metroplex with an upcoming pain clinic visit.
Not a fit: People actively receiving neurotoxic cancer treatment, without smartphone/internet access, with significant cognitive impairment, living outside the Houston area, or with low symptom burden (<4/10) are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the approach could help patients focus on and achieve personally meaningful goals, potentially improving symptom management and quality of life.
How similar studies have performed: Goal Attainment Scaling has shown utility in other chronic conditions, but applying GAS specifically to chemotherapy-induced peripheral neuropathy is novel and has not been tested in large trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Alice Ye, MD — M.D. Anderson Cancer Center
- Study coordinator: Alice Ye, MD
- Email: alye@mdanderson.org
- Phone: 713-745-2933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.