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NCT06945380 | NOT YET RECRUITING | Chemotherapy-Induced Peripheral Neuropathy

Evaluating a Mobile Health Application Intervention for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

Cindy Tofthagen

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.

Condition or disease

Chemotherapy-Induced Peripheral Neuropathy

Malignant Solid Neoplasm

Intervention/treatment

Best Practice, Comparator Program

Best Practice, Usual Care

Internet-Based Intervention

Massage Therapy

Survey Administration

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : mHealth App for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
Actual Study Start Date : 2025-05-15
Estimated Primary Completion Date : 2026-03-31
Estimated Study Completion Date : 2026-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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 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).
  • * 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.
Evaluating a Mobile Health Application Intervention for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy

Location Details

NCT06945380

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How to Participate

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Locations

Not yet recruiting

United States, Florida

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980