Clinical trial NCT05508984: Clinical Outcomes and Patient Satisfaction With Use of the Amma System
Official title: Observational Study of Clinical Outcomes and Patient Satisfaction With Use of the Amma System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Amma, Cooler Heads
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Cooler Heads
First posted: 2022-08-19
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with stage I-III breast cancer are eligible to participate if they have a curative-intent chemotherapy regimen.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: AMMA Feasibility Within PH&S System
timeFrame: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Secondary outcomes:
measure: Patient Reported Outcome Utilizing Dean's Score
timeFrame: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
measure: Patient Reported Outcome Utilizing Body Image Scale
timeFrame: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
measure: Patient Satisfaction Utilizing the Was It Worth It Questionnaire
timeFrame: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Other outcomes:
Locations:
city: Newberg
country: United States
facility: Providence Cancer Institute - Newberg Clinic
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Oncology and Hematology Care - Westside
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: David Page, MD
role: PRINCIPAL_INVESTIGATOR
References: