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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Best Practice, Comparator Program
  Receive access to a comparator program
• Другое Best Practice, Usual Care
  Receive usual care
• Другое Internet-Based Intervention
  Receive access to the PNR program
• Процедура Massage Therapy
  Perform the relaxation massage techniques
• Другое Survey Administration
  Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes

Первичные конечные точки

• Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient) [Срок оценки: At baseline, 6 and 12 weeks]
• Change in caregiver esteem (Caregiver) [Срок оценки: At baseline, 6 and 12 weeks]
• Change in attitude toward caregiving with CIPN (Caregiver) [Срок оценки: At baseline, 6 and 12 weeks]

Вторичные конечные точки (3)

• Change in global well-being (Patient and caregiver) [Срок оценки: At baseline, 6 and 12 weeks]
• Change in caregiving impact (Caregiver) [Срок оценки: At baseline, 6 and 12 weeks]
• Session effects (Patient, PNR and relaxation massage groups only) [Срок оценки: Weeks 1-12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT06945380 · 23-012668 · R43CA268678

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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