Clinical trial NCT06945380: Evaluating a Mobile Health Application Intervention for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
Official title: mHealth App for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Collinge and Associates, Inc.
name: IRIS Media Inc
First posted: 2025-04-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: usual care, attention control, and intervention groups
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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.

Primary outcomes:
measure: Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient)
timeFrame: At baseline, 6 and 12 weeks
measure: Change in caregiver esteem (Caregiver)
timeFrame: At baseline, 6 and 12 weeks
measure: Change in attitude toward caregiving with CIPN (Caregiver)
timeFrame: At baseline, 6 and 12 weeks
Secondary outcomes:
measure: Change in global well-being (Patient and caregiver)
timeFrame: At baseline, 6 and 12 weeks
measure: Change in caregiving impact (Caregiver)
timeFrame: At baseline, 6 and 12 weeks
measure: Session effects (Patient, PNR and relaxation massage groups only)
timeFrame: Weeks 1-12
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Cindy Tofthagen, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Collinge and Associates, Inc.
name: William Collinge, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: