Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Interventions
OTHERBest Practice, Comparator Program
Receive access to a comparator program
OTHERBest Practice, Usual Care
Receive usual care
OTHERInternet-Based Intervention
Receive access to the PNR program
PROCEDUREMassage Therapy
Perform the relaxation massage techniques
OTHERSurvey Administration
Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Collinge and Associates, Inc.
IRIS Media Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
usual care, attention control, and intervention groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient) | 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. |
| Change in caregiver esteem (Caregiver) | 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. |
| Change in attitude toward caregiving with CIPN (Caregiver) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in global well-being (Patient and caregiver) | 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. |
| Change in caregiving impact (Caregiver) | 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. |
| Session effects (Patient, PNR and relaxation massage groups only) | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCindy Tofthagen, PhD, RN
Mayo Clinic
PRINCIPAL_INVESTIGATORWilliam Collinge, PhD, MPH
Collinge and Associates, Inc.
Outcome results
None listed