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

NCT06945380 | Recruiting

• 2 other identifiers: 23-012668R43CA268678
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (3)

• Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient)

  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.

  At baseline, 6 and 12 weeks

• Change in caregiver esteem (Caregiver)

  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.

  At baseline, 6 and 12 weeks

• Change in attitude toward caregiving with CIPN (Caregiver)

  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.

  At baseline, 6 and 12 weeks

Secondary Outcomes (3)

• Change in global well-being (Patient and caregiver)

  At baseline, 6 and 12 weeks

• Change in caregiving impact (Caregiver)

  At baseline, 6 and 12 weeks

• Session effects (Patient, PNR and relaxation massage groups only)

  Weeks 1-12

Study Arms (3)

Arm I (PNR program)

EXPERIMENTAL

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. (COMPLETED 04/07/2025)

Other: Internet-Based Intervention; Procedure: Massage Therapy; Other: Survey Administration

Arm II (attention control)

ACTIVE COMPARATOR

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. (COMPLETED 04/07/2025)

Other: Best Practice, Comparator Program; Other: Survey Administration

Arm III (waitlist control)

ACTIVE COMPARATOR

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

Other: Best Practice, Usual Care; Other: Survey Administration

Interventions

Internet-Based Intervention OTHER

Receive access to the PNR program

Arm I (PNR program)

Massage Therapy PROCEDURE

Perform the relaxation massage techniques

Also known as: Massage

Arm I (PNR program)

Survey Administration OTHER

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

Arm I (PNR program); Arm II (attention control); Arm III (waitlist control)

Best Practice, Usual Care OTHER

Receive usual care

Also known as: best practice, standard of care, standard therapy

Arm III (waitlist control)

Best Practice, Comparator Program OTHER

Receive access to a comparator program

Also known as: best practice, standard of care, standard therapy

Arm II (attention control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator
• Collinge and Associates, Inc.: collaborator
• IRIS Media Inc: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Massage

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Cindy Tofthagen, PhD, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• William Collinge, PhD, MPH

  Collinge and Associates, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine Sheffield

CONTACT

904-953-3972; Sheffield.Katharine@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: usual care, attention control, and intervention groups

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: April 25, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: June 1, 2026 -indefinitely
• Access Criteria: to be determined

Locations

US (1)