mHealth App for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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.

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Katharine Sheffield
Sheffield.Katharine@mayo.edu
904-953-3972
Backup
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 300
Treatments
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.
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.
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.
Sponsors
Leads: Mayo Clinic
Collaborators: IRIS Media Inc, Collinge and Associates, Inc., National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov