Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05508984
• Other study ID #: 2022000438
• Status: Active, not recruiting
• Start date: August 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Amma Cooling Caps
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.

Locations

Country	Name	City	State
United States	Providence Cancer Institute - Newberg Clinic	Newberg	Oregon
United States	Providence Oncology and Hematology Care - Westside	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Providence Health & Services	Cooler Heads

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)