Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Sponsor
Providence Health & Services (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05508984
Collaborator
Cooler Heads (Other)
15
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Amma Cooling Caps

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Observational Study of Clinical Outcomes and Patient Satisfaction With Use of the Amma System
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. AMMA Feasibility Within PH&S System [End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)]

    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.

Secondary Outcome Measures

  1. Patient Reported Outcome Utilizing Dean's Score [End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)]

    Patient satisfaction will be assessed via alopecia assessment utilizing Deans Scale collected at baseline and at end of treatment.

  2. Patient Reported Outcome Utilizing Body Image Scale [End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)]

    Patient satisfaction will be assessed utilizing the Body Image Scale (BIS) questionnaire.

  3. Patient Satisfaction Utilizing the Was It Worth It Questionnaire [End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)]

    Patient satisfaction will be assessed utilizing the Was It Worth It (WIWI) questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Providence Health & Services
  • Cooler Heads

Investigators

  • Principal Investigator: David Page, MD, Providence Health & Services

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT05508984
Other Study ID Numbers:
  • 2022000438
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Providence Health & Services

Study Results

No Results Posted as of Aug 19, 2022