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NCT Number: NCT06945380

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Cindy Tofthagen, PhD, RN

PRINCIPAL_INVESTIGATOR

Katharine Sheffield

CONTACT

[email protected]

904-953-3972

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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).

Treatment and study plan

Best Practice, Comparator Program

Other

Receive access to a comparator program

Other names: best practice, standard of care, standard therapy

Best Practice, Usual Care

Other

Receive usual care

Other names: best practice, standard of care, standard therapy

Internet-Based Intervention

Other

Receive access to the PNR program

Massage therapy

Procedure

Perform the relaxation massage techniques

Other names: Massage

Survey Administration

Other

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

Primary outcomes

  1. Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient)

    Time frame: 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.

  2. Change in caregiver esteem (Caregiver)

    Time frame: 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.

  3. Change in attitude toward caregiving with CIPN (Caregiver)

    Time frame: 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.

Secondary outcomes

  1. Change in global well-being (Patient and caregiver)

    Time frame: At baseline, 6 and 12 weeks

    Will be measured using the Short Form 12 version 2 (SF12v2). The SF12v2 consists of 12 questions and is used to assess health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health.

  2. Change in caregiving impact (Caregiver)

    Time frame: At baseline, 6 and 12 weeks

    Will be measured using the Caregiver Reaction Assessment (CRA), a 24-item scale covering five dimensions of caregiving and producing five subscale scores and a total score representing overall caregiver burden. Items are answered on a 5-point scale where 1=strongly disagree and 5=strongly agree. Higher scores generally indicate a more negative impact.

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

    Time frame: Weeks 1-12

    Will be measured using weekly reporting session symptom ratings. Within 15 minutes before and again within 15 minutes after the reporting session, patients enter Likert scaled ratings of (1) numbness in hands/fingers, (2) numbness in feet/toes, (3) tingling in hands/fingers, (4) tingling in feet/toes, (5) discomfort in hands/fingers, (6) discomfort in feet/toes. After a Reporting Session patients also rate (7) overall satisfaction with the session received. An open response question (8) invites any comments or observations about the session that they may wish to offer (to be treated as qualitative data).

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Katharine Sheffield

CONTACT

[email protected]

904-953-3972

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Collinge and Associates, Inc.
  • IRIS Media Inc
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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