Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Study Overview
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Brief Summary
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The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients within oncology suites within the PH&S system.

Detailed Description
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A novel cold capping device, named Amma™, is now commercially available for use and FDA approved. The Amma system has the potential to be as effective as the Penguin Cold Cap system, but with key innovations that make it more efficient and feasible in the clinic. Innovations include: Portable and battery powered unit, not requiring dry ice Form-fitting scalp cap that eliminates the need for frequent cap exchanges The Amma system has not been evaluated for efficacy, and no clinical trials are published. Because of the ease of use and the self-directed administration of the Amma scalp cooling device, we wish to explore this as an option for patients treated within the PH&S system. To do this, we propose an observational study that evaluates clinical outcomes and patient-reported satisfaction amongst a cohort of patients who undergo self-directed scalp cooling using the Amma system.

Official Title
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Observational Study of Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Amma Cooling Caps


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Women with stage I-III breast cancer are eligible to participate if: They consent to conduct baseline (week 0) and follow-up (week 4 post-chemo) surveys/interviews They consent to be photographed at baseline (week 0) and follow-up (week 4 post-chemo), to document hair retention outcomes Curative-intent chemotherapy is planned with a taxane-based, anthracycline-sparing chemotherapy regimen (which includes but may not be limited to: TC x 4, T x 12, TCHP x6)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Anywhere from 14 to 0 days prior to treatment, enrolled subjects will complete the following questionnaires, and their hair will be photographed by research staff. Once enrolled, subjects will be provided the Amma device by the clinic on days of chemotherapy treatment, and upon completion of treatment it will be returned to the clinic for safekeeping. Upon completion of chemotherapy, anywhere from 3-6 weeks following treatment, subjects will repeat the questionnaires and their hair will be photographed again. Subjects will then complete their enrollment in the study. | Device: Amma Cooling Caps<br>* Once enrolled, subjects will be provided the Amma device by the clinic on days of chemotherapy treatment, and upon completion of treatment it will be returned to the clinic for safekeeping. Upon completion of chemotherapy, anywhere from 3-6 weeks following treatment, subjects will repeat the questionnaires and their hair will be photographed again. The overall duration of the study for subjects will be anywhere from 4 months to 8 months, depending on the duration of their chemotherapy regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMMA Feasibility Within PH&S System | The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients with early-stage breast cancer within oncology suites within the PH&S system. Patient satisfaction will be assessed using pre and post treatment questionnaires related to the Amma system and an exit interview. | End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome Utilizing Dean's Score | Patient satisfaction will be assessed via alopecia assessment utilizing Deans Scale collected at baseline and at end of treatment. | End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen) | 
| Patient Reported Outcome Utilizing Body Image Scale | Patient satisfaction will be assessed utilizing the Body Image Scale (BIS) questionnaire. | End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen) | 
| Patient Satisfaction Utilizing the Was It Worth It Questionnaire | Patient satisfaction will be assessed utilizing the Was It Worth It (WIWI) questionnaire. | End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amma, Cooler Heads