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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; Chemotherapy-Induced Peripheral Neuropathy; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Internet-Based Intervention; Procedure: Massage Therapy; Other: Survey Administration; Other: Best Practice, Comparator Program; Other: Best Practice, Usual Care

• Study Type: Interventional
• Enrollment (Actual): 348
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18+ years of age.
• Must speak and read English.
• Have internet access.
• PATIENTS: Must have received neurotoxic chemotherapy for adjuvant treatment of cancer.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Survey Administration; Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes; Other: Best Practice, Usual Care; Receive usual care; Other Names: standard of care; standard therapy; best practice
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)	Other: Internet-Based Intervention; Receive access to the PNR program; Procedure: Massage Therapy; Perform the relaxation massage techniques; Other Names: Massage; Other: Survey Administration; Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes
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)	Other: Survey Administration; Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes; Other: Best Practice, Comparator Program; Receive access to a comparator program; Other Names: standard of care; standard therapy; best practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in caregiver esteem (Caregiver)	Will be measured using the 7-item esteem subscale of the Caregiver Reaction Assessment (CRA). The 7-item caregiver esteem subscale assesses the extent to which the caregiver experiences a sense of value and satisfaction in caregiving. Items are answered on a 5-point scale where 1=strongly disagree and 5=strongly agree. Higher scores indicate more positive self-esteem.	At baseline, 6 and 12 weeks
Change in attitude toward caregiving with CIPN (Caregiver)	Will be measured using an Attitudes toward Caregiving with CIPN questionnaire developed by the investigators. Six questions are answered on a 5-point scale where 1=not at all and 5=extremely.	At baseline, 6 and 12 weeks
Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient)	Will be measured using the Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT), a 69-item questionnaire used to assess CIPN symptoms and their impact on daily activities. Scores range from 0 to 140. Higher scores indicate greater severity of neuropathy.	At baseline, 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in global well-being (Patient and caregiver)	Will be measured using the Short Form 12 version 2 (SF12v2). The SF12v2 consists of 12 questions and is used to assess health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health.	At baseline, 6 and 12 weeks
Change in caregiving impact (Caregiver)	Will be measured using the Caregiver Reaction Assessment (CRA), a 24-item scale covering five dimensions of caregiving and producing five subscale scores and a total score representing overall caregiver burden. Items are answered on a 5-point scale where 1=strongly disagree and 5=strongly agree. Higher scores generally indicate a more negative impact.	At baseline, 6 and 12 weeks
Session effects (Patient, PNR and relaxation massage groups only)	Will be measured using weekly reporting session symptom ratings. Within 15 minutes before and again within 15 minutes after the reporting session, patients enter Likert scaled ratings of (1) numbness in hands/fingers, (2) numbness in feet/toes, (3) tingling in hands/fingers, (4) tingling in feet/toes, (5) discomfort in hands/fingers, (6) discomfort in feet/toes. After a Reporting Session patients also rate (7) overall satisfaction with the session received. An open response question (8) invites any comments or observations about the session that they may wish to offer (to be treated as qualitative data).	Weeks 1-12

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI); Collinge and Associates, Inc.; IRIS Media Inc
• Investigators: Principal Investigator: William Collinge, PhD, MPH, Collinge and Associates, Inc.; Principal Investigator: Cindy Tofthagen, PhD, RN, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2025
• Primary Completion (Actual): June 8, 2026
• Study Completion (Actual): June 8, 2026

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Quality of Health Care; Complementary Therapies; Physical Therapy Modalities; Quality Indicators, Health Care; Rehabilitation; Guidelines as Topic; Quality Assurance, Health Care; Therapy, Soft Tissue; Musculoskeletal Manipulations; Standard of Care; Practice Guidelines as Topic; Massage
• Other Study ID Numbers: 23-012668 (Mayo Clinic Institutional Review Board); R43CA268678 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be de-identified and shared with other researchers after the findings are published, and upon request.
• IPD Sharing Time Frame: June 1, 2026 -indefinitely
• IPD Sharing Access Criteria: to be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No