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| ID | Type | Description | Link |
|---|---|---|---|
| R43CA268678 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Collinge and Associates, Inc. | OTHER |
| IRIS Media Inc | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice, Comparator Program | Other | Receive access to a comparator program |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | At baseline, 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, 6 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharine Sheffield | Contact | 904-953-3972 | Sheffield.Katharine@mayo.edu | |
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cindy Tofthagen, PhD, RN | Mayo Clinic | Principal Investigator |
| William Collinge, PhD, MPH | Collinge and Associates, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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IPD will be de-identified and shared with other researchers after the findings are published, and upon request.
June 1, 2026 -indefinitely
to be determined
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usual care, attention control, and intervention groups
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| Best Practice, Usual Care | Other | Receive usual care |
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| Internet-Based Intervention | Other | Receive access to the PNR program |
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| Massage Therapy | Procedure | Perform the relaxation massage techniques |
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| Survey Administration | Other | Complete surveys to assess CIPN symptoms, overall well-being and quality of life, and caregiver reaction and attitudes |
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| 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. |
| 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). | Weeks 1-12 |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D008405 | Massage |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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