Clinical Outcomes and Patient Satisfaction With Use of the Amma System

NCT05508984 | Active Not Recruiting FDA Device

• 1 other identifier: 2022000438
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

Amma, Cooler Heads

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Reported Outcome Utilizing Dean's Score

  End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)

• Patient Reported Outcome Utilizing Body Image Scale

  End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)

• Patient Satisfaction Utilizing the Was It Worth It Questionnaire

  End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)

Study Arms (1)

Single Arm

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

Interventions

Amma Cooling Caps DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with stage I-III breast cancer are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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)

Sponsors & Collaborators

• Providence Health & Services: lead
• Cooler Heads: collaborator

Study Sites (3)

Providence Cancer Institute - Newberg Clinic

Newberg, Oregon, 97132, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Oncology and Hematology Care - Westside

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Page, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 19, 2022
• Study Start: August 22, 2022
• Primary Completion: January 24, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)