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

NCT ID: NCT06945380

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-27
• Study Completion Date: 2026-03-31

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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy; Malignant Solid Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Internet-Based Intervention

Intervention Type: OTHER

Receive access to the PNR program

Massage Therapy

Intervention Type: PROCEDURE

Perform the relaxation massage techniques

Survey Administration

Intervention Type: OTHER

Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes

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.

Group Type: ACTIVE_COMPARATOR

Best Practice, Comparator Program

Intervention Type: OTHER

Receive access to a comparator program

Survey Administration

Intervention Type: OTHER

Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes

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.

Group Type: ACTIVE_COMPARATOR

Best Practice, Usual Care

Intervention Type: OTHER

Receive usual care

Survey Administration

Intervention Type: OTHER

Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes

Interventions

Best Practice, Comparator Program

Receive access to a comparator program

Intervention Type: OTHER

Best Practice, Usual Care

Receive usual care

Intervention Type: OTHER

Internet-Based Intervention

Receive access to the PNR program

Intervention Type: OTHER

Massage Therapy

Perform the relaxation massage techniques

Intervention Type: PROCEDURE

Survey Administration

Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes

Intervention Type: OTHER

Other Intervention Names

best practice; standard of care; standard therapy; best practice; standard of care; standard therapy; Massage

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Collinge and Associates, Inc.

OTHER

Sponsor Role: collaborator

IRIS Media Inc

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Cindy Tofthagen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cindy Tofthagen, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

William Collinge, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Collinge and Associates, Inc.

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katharine Sheffield

Role: CONTACT

Sheffield.Katharine@mayo.edu

904-953-3972

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Katharine Sheffield

Role: primary

Sheffield.Katharine@mayo.edu

904-953-3972

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2024-04430

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-012668

Identifier Type: OTHER

Identifier Source: secondary_id

R43CA268678

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-012668

Identifier Type: -

Identifier Source: org_study_id