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Mobile Health App for Chemotherapy-Induced Peripheral Neuropathy

This study is testing a mobile health app called PNR that teaches caregivers how to perform a special massage technique for loved ones experiencing chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a common side effect of cancer treatment, causing numbness, tingling, or pain in hands and feet. The study wants to see if this caregiver-delivered massage can improve CIPN symptoms for patients and also improve caregivers' feelings about their role. You might be able to join if you are 18 or older, speak English, have internet access, and are a cancer survivor who received neurotoxic chemotherapy and has moderate to severe CIPN. The study is currently unclear about its recruitment status and plans to enroll 300 participants.

Study design
This interventional study plans to enroll 300 participants. Participants will be assigned to either receive access to the PNR program, a comparator program, or usual care.
What's involved
Participants will complete surveys at the start of the study, and again at 6 and 12 weeks to assess CIPN symptoms, well-being, and caregiver attitudes.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06945380

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

Completed
NAAges 18+InterventionalSupportive care
Mayo Clinic
~348 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Best Practice, Comparator ProgramBest Practice, Usual CareInternet-Based InterventionMassage TherapySurvey Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient)
Measured over At baseline, 6 and 12 weeks
+2 more outcomes measured

Conditions

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

Explore related trials

Chemotherapy-Induced Peripheral NeuropathyHematologic NeoplasmSolid Neoplasm

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Cindy Tofthagen, PhD, RN · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • William Collinge, PhD, MPH · PRINCIPAL_INVESTIGATOR · Collinge and Associates, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient)At baseline, 6 and 12 weeks

    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.

  • Change in caregiver esteem (Caregiver)At baseline, 6 and 12 weeks

    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.

  • Change in attitude toward caregiving with CIPN (Caregiver)At baseline, 6 and 12 weeks

    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.