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

Mayo Clinic

Status: Begins enrollment this month

Conditions: Chemotherapy-Induced Peripheral Neuropathy; Malignant Solid Neoplasm

Treatments: Procedure: Massage Therapy; Other: Best Practice, Comparator Program; Other: Survey Administration; Other: Internet-Based Intervention; Other: Best Practice, Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06945380

R43CA268678 (U.S. NIH Grant/Contract)

NCI-2024-04430 (Registry Identifier)

23-012668 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Arm I (PNR program)

Experimental group

Description:

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.

Treatment:

Other: Internet-Based Intervention

Other: Survey Administration

Procedure: Massage Therapy

Arm II (attention control)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Best Practice, Comparator Program

Arm III (waitlist control)

Active Comparator group

Description:

Dyads receive usual care for 12 weeks. Dyads may optionally receive access to the PNR program following the initial 12-week study period.

Treatment:

Other: Best Practice, Usual Care

Other: Survey Administration