RECRUITING

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

Talk to us

Conditions

Chemotherapy-Induced Peripheral NeuropathyMalignant Solid Neoplasm

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-27
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06945380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18+ years of age.
  2. * Must speak and read English.
  3. * Have internet access.
  4. * PATIENTS: Must have received platinum and/or taxane chemotherapy for adjuvant treatment of a solid tumor.
  5. * 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.
  6. * 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.
  7. * PATIENTS: Must have internet access.
  8. * 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.
  1. * PATIENTS: Other potential cause of neuropathy (e.g., diabetes).
  2. * PATIENTS: Ongoing treatment with a neuropathy-causing medication.
  3. * PATIENTS: History of oncology massage therapy for neuropathy in the last 3 months.
  4. * 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).
  5. * 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.

Contacts and Locations

Study Contact

Katharine Sheffield
CONTACT
904-953-3972
Sheffield.Katharine@mayo.edu
Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2025-05-27
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chemotherapy-Induced Peripheral Neuropathy
  • Malignant Solid Neoplasm