NCT06945380 Evaluating a Mobile Health Application Intervention for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
| NCT ID | NCT06945380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Chemotherapy-Induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-05-27 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial assesses the impact of a family caregiver-delivered massage technique for use in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a common cancer treatment side effect that impairs quality of life and daily functioning. Aside from the relatively transient effects of chemotherapy treatment (e.g., nausea, diarrhea, vomiting, infections, fatigue, hair loss), chemotherapy can damage nervous system structures leading to long-term CIPN effects including numbness in hands or feet, "pins and needles" or sudden stabbing pains, difficulty buttoning clothing or picking up objects, loss of balance and risk of falling, difficulty driving (steering wheel, foot pedals), and increased sensitivity to heat or cold. Caregivers who lack effective strategies of supportive care are at risk of feeling helpless, overwhelmed or frustrated watching their loved one suffer. Oncology massage (OM) teaches oncology-informed modifications, adaptations and safety precautions for a cancer survivor's specific condition, treatment history and side effects. An mobile health application (app) for caregivers can teach care for CIPN using safe oncology-informed massage techniques at home. Using the Peripheral Neuropathy Relief (PNR) program in the form of relaxation may help for stress reduction, reduced CIPN symptoms, and/or an increased sense of connection with patients and their family caregiver.
Eligibility Criteria
Inclusion Criteria: * 18+ years of age. * Must speak and read English. * Have internet access. * PATIENTS: Must have received neurotoxic chemotherapy for adjuvant treatment of cancer. * PATIENTS: Screens positive for moderate to severe CIPN with a 4+ on a 0-10 scale, with 0 being no numbness/tingling or pain in hands or feet and 10 being most severe imaginable. * PATIENTS: Last chemo dose must be 6+ months in the past (symptoms persist in 30% of recipients \> 6 months, this assures those with established chronicity are included, reducing likelihood of spontaneous improvement). Also, no new chemotherapy should be anticipated during the study course. * PATIENTS: Must have internet access. * CAREGIVERS: Members of the patient's natural social support system including spouse, intimate partner, other family member (adult child, parent, other relative), friend or other lay person designated by the patient who agrees to serve as caregiver for the activities of the project. Exclusion Criteria: * PATIENTS: Other potential cause of neuropathy (e.g., diabetes). * PATIENTS: Ongoing treatment with a neuropathy-causing medication. * PATIENTS: History of oncology massage therapy for neuropathy in the last 3 months. * PATIENTS: Unstable lymphedema-if the patient is considered at risk of lymphedema, they can participate because level 2 pressure is deemed safe; however, if patient has had lymphedema, their condition must be declared stable by a certified lymphedema therapist (if stable, level 2 pressure is safe for this study's interventions).
Contact & Investigator
Cindy Tofthagen, PhD, RN
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06945380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-Induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06945380 currently recruiting?
Yes, NCT06945380 is actively recruiting participants. Contact the research team at Sheffield.Katharine@mayo.edu for enrollment information.
Where is the NCT06945380 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT06945380 clinical trial?
NCT06945380 is sponsored by Mayo Clinic. The principal investigator is Cindy Tofthagen, PhD, RN at Mayo Clinic. The trial plans to enroll 300 participants.