Status:
RECRUITING
Evaluating a Mobile Health Application Intervention for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Collinge and Associates, Inc.
Conditions:
Chemotherapy-Induced Peripheral Neuropathy
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
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 tr...
Eligibility Criteria
Inclusion
- 18+ years of age.
- Must speak and read English.
- Have internet access.
- PATIENTS: Must have received platinum and/or taxane chemotherapy for adjuvant treatment of a solid tumor.
- 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
- 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).
- PATIENTS: Stage IV patients are excluded because many are on active medications that continue to cause or exacerbate neuropathy, and would confound results; active metastases introduce increased risks with massage; and general comfort massage for supportive care would be more indicated than targeting CIPN.
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06945380
Start Date
May 27 2025
End Date
March 31 2026
Last Update
June 25 2025
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980