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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06945380
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Best Practice, Comparator Program — OTHER
    Receive access to a comparator program
  • Best Practice, Usual Care — OTHER
    Receive usual care
  • Internet-Based Intervention — OTHER
    Receive access to the PNR program
  • Massage Therapy — PROCEDURE
    Perform the relaxation massage techniques
  • Survey Administration — OTHER
    Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
May 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (PNR program)
    Dyads receive access to the PNR program to perform the relaxation massage techniques consisting of site restrictions, pressure restrictions, stroke direction and stroke length at least three times in a week (TIW) over 15-20 minutes for 12 weeks. (COMPLETED 04/07/2025)
  • Active Comparator: Arm II (attention control)
    Dyads receive access to a comparator program to perform the relaxation massage techniques at least TIW over 15-20 minutes for 12 weeks. Dyads may optionally receive access to the PNR program following the initial 12-week study period. (COMPLETED 04/07/2025)
  • Active Comparator: Arm III (waitlist control)
    Dyads receive usual care for 12 weeks. Dyads may optionally receive access to the PNR program following the initial 12-week study period.

Primary Outcome Measure

Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient) [ Time Frame: At baseline, 6 and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Katharine Sheffield
[email protected]
904-953-3972
Cindy Tofthagen, PhD, RN (PRINCIPAL_INVESTIGATOR)

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