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

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.

Conditions

• Chemotherapy-Induced Peripheral Neuropathy
• Malignant Solid Neoplasm
• Hematopoietic and Lymphatic System Neoplasm

Interventions

OTHER

Best Practice, Comparator Program

Receive access to a comparator program

OTHER

Best Practice, Usual Care

Receive usual care

OTHER

Internet-Based Intervention

Receive access to the PNR program

PROCEDURE

Massage Therapy

Perform the relaxation massage techniques

OTHER

Survey Administration

Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Collinge and Associates, Inc.

  collaborator OTHER

• IRIS Media Inc

  collaborator OTHER

• Mayo Clinic

  lead OTHER

Principal Investigators

• Cindy Tofthagen, PhD, RN · Mayo Clinic

• William Collinge, PhD, MPH · Collinge and Associates, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-27

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• United States

Study Locations