Chemotherapy-Induced Peripheral NeuropathyNCT06945380
Evaluating a Mobile Health Application Intervention for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
A study testing Best Practice, Comparator Program, Internet-Based Intervention and Massage Therapy in people with Chemotherapy-Induced Peripheral Neuropathy and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Best Practice, Comparator Program, Internet-Based Intervention and Massage Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: mHealth App 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.
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- Being tested
- Best Practice, Comparator Program, Best Practice, Usual Care, Internet-Based Intervention, Massage Therapy, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice, Comparator ProgramOther
Also called best practice, standard of care, standard therapy
Receive access to a comparator program
Best Practice, Usual CareOther
Also called best practice, standard of care, standard therapy
Receive usual care
Internet-Based InterventionOther
Receive access to the PNR program
Massage TherapyProcedure or surgery
Also called Massage
Perform the relaxation massage techniques
Survey AdministrationOther
Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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. Receives: Other: Best Practice, Usual Care; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline, 6 and 12 weeks
Secondary outcomes (3)
Change in global well-being (Patient and caregiver)
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.
Measured: At baseline, 6 and 12 weeks
Change in caregiving impact (Caregiver)
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.
Measured: At baseline, 6 and 12 weeks
Session effects (Patient, PNR and relaxation massage groups only)
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).
Measured: Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start5 Jun 2025
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- usual care, attention control, and intervention groups
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Collinge and Associates, Inc., IRIS Media Inc
- Responsible party
- Principal investigator, Cindy Tofthagen, Mayo Clinic
- Investigators
- Cindy Tofthagen, PhD, RN, Principal investigator, Mayo ClinicWilliam Collinge, PhD, MPH, Principal investigator, Collinge and Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945380
- Sponsor's protocol ID
- 23-012668
- Other IDs
- R43CA268678
- Status last verified
- Aug 2026
- First submitted
- 22 May 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be de-identified and shared with other researchers after the findings are published, and upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth App for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06945380
- Acronym / sponsor ID
- 23-012668
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Collinge and Associates, Inc., IRIS Media Inc
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- usual care, attention control, and intervention groups
| Arm | Type | Receives |
|---|---|---|
| Arm I (PNR program) | Experimental | Other: Internet-Based Intervention, Procedure: Massage Therapy, Other: Survey AdministrationDyads 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) |
| Arm II (attention control) | Active comparator | Other: Best Practice, Comparator Program, Other: Survey AdministrationDyads 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) |
| Arm III (waitlist control) | Active comparator | Other: Best Practice, Usual Care, Other: Survey AdministrationDyads receive usual care for 12 weeks. Dyads may optionally receive access to the PNR program following the initial 12-week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Practice, Comparator ProgramAlso: best practice, standard of care, standard therapyReceive access to a comparator program | Other | Arm II (attention control) |
| Best Practice, Usual CareAlso: best practice, standard of care, standard therapyReceive usual care | Other | Arm III (waitlist control) |
| Internet-Based InterventionReceive access to the PNR program | Other | Arm I (PNR program) |
| Massage TherapyAlso: MassagePerform the relaxation massage techniques | Procedure or surgery | Arm I (PNR program) |
| Survey AdministrationComplete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes | Other | Arm I (PNR program), Arm II (attention control), Arm III (waitlist control) |
Primary outcome
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.
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.
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.
3 secondary outcomes
Change in global well-being (Patient and caregiver)
Time frame: At baseline, 6 and 12 weeks
Change in caregiving impact (Caregiver)
Time frame: At baseline, 6 and 12 weeks
Session effects (Patient, PNR and relaxation massage groups only)
Time frame: Weeks 1-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be de-identified and shared with other researchers after the findings are published, and upon request.
Related trials for Chemotherapy-Induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Tofthagen, PhD, RN principal investigator
Mayo Clinic
William Collinge, PhD, MPH principal investigator
Collinge and Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Comparator Program, Internet-Based Intervention and Massage Therapy in people with Chemotherapy-Induced Peripheral Neuropathy and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in chemotherapy-induced peripheral neuropathy (CIPN) (Patient) (time frame: At baseline, 6 and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.