Mobile app training for caregivers to provide manual massage for chemotherapy-related nerve pain
mHealth App for Caregiver Instruction in Manual Therapy for Chemotherapy-Induced Peripheral Neuropathy
This test uses a mobile app to teach family caregivers how to give safe, oncology-informed massage to cancer survivors who continue to have nerve pain or numbness after neurotoxic chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06945380 on ClinicalTrials.gov |
What this trial studies
The intervention trains a patient's natural caregiver via a mobile health application to deliver modified manual massage aimed at reducing symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Eligible participants are adult cancer survivors who completed neurotoxic chemotherapy at least six months earlier, report moderate to severe CIPN (≥4/10), and have an English-speaking caregiver with internet access. Caregivers follow online instructional modules and perform a prescribed massage program while investigators collect symptom and caregiver-experience data using surveys and symptom scales compared to usual-care or best-practice education groups. The protocol is run through Mayo Clinic in Florida and leverages internet delivery to broaden access while monitoring adherence and safety.
Who should consider this trial
Good fit: Adult cancer survivors who finished neurotoxic chemotherapy at least six months ago, report moderate-to-severe CIPN (≥4/10), have a willing English-speaking lay caregiver, and have internet access are ideal candidates.
Not a fit: People without a willing caregiver, those with mild or very recent CIPN (less than six months since chemotherapy), non-English speakers, or those with severe neuropathy requiring medical interventions may not benefit from this program.
Why it matters
Potential benefit: If successful, this approach could reduce CIPN symptoms, improve daily function and quality of life for survivors, and give caregivers practical tools and increased confidence.
How similar studies have performed: Small trials and pilot projects have shown some benefit from oncology-informed massage or manual therapies for CIPN, but caregiver-delivered, app-based instruction is a relatively novel approach with limited large-scale evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Cindy Tofthagen, PhD, RN — Mayo Clinic
- Study coordinator: Katharine Sheffield
- Email: Sheffield.Katharine@mayo.edu
- Phone: 904-953-3972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.