Apollo Device for Metastatic Breast Cancer (MBC)

NCT ID: NCT04983342

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-08-09

Brief Summary

This is a single-arm, open label pilot intervention study with outcomes measured by electronic survey and chart review evaluating a wearable device called Apollo, which is similar to a FitBit but emits vibrations. Our primary objective is to assess whether or not Apollo can help with symptoms of fatigue and pain in patients with Metastatic Breast Cancer (MBC).

Detailed Description

This study aims to provide preliminary data on the efficacy and tolerability of the Apollo device in the management of fatigue and pain in patients with Metastatic Breast Cancer (MBC).

Apollo is about the size of an Apple Watchand can be worn on the ankle, wrist, or armwith two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears. The scientific principles guiding the use of Apollo and mechanistic understanding of its effects on the body are consistent with the understanding of how music and therapeutic touch effect the body to convey feelings of energy, focus, or relaxation by sending safety signals to the emotional cortex (limbic system) in the brain. Similar to music and touch used to facilitate a healing response in the body, there are no known side effects to this type of therapy.

The PROMIS-Fatigue scale and the Functional Assessment of Cancer Therapy Fatigue (FACT-F) are instruments that have been previously validated in multiple diseases and will be used in this study. Preliminary data on indices of pain, use of PRN pain medications, health-related quality of life, sleep, anxiety and depression and tolerability/frequency of use with the Apollo device in MBC will also be evaluated using:

• PROMIS pain scale
• Use of pain medications
• Health-related quality of life (HRQOL) using PROMIS-29
• PROMIS Sleep
• Hospital Anxiety and Depression Scale (HADS)
• Usage data from Apollo app

This study aims to identify improvement of fatigue symptoms from baseline after 4 and 8 weeks of Apollo use. Improvements in pain, quality of life, use of PRN pain medication, anxiety and sleep.

Conditions

Fatigue; Metastatic Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Apollo Armband

Armband that can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain.

Group Type: EXPERIMENTAL

Apollo Armband

Intervention Type: DEVICE

The Apollo armband is approximately the size of an Apple Watch and can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears.

Interventions

Apollo Armband

The Apollo armband is approximately the size of an Apple Watch and can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Metastatic breast cancer diagnosis
• Fatigue score of 4 or greater at last clinic visit

Exclusion Criteria

• Not able to read and understand English
• Use of Beta Blockers,
• Use of medications for serious mental illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Apollo Neuroscience, Inc.

INDUSTRY

Sponsor Role: collaborator

Margaret Quinn Rosenzweig

OTHER

Sponsor Role: lead

Responsible Party

Margaret Quinn Rosenzweig

Distinguished Service Professor of Nursing, Professor of Medicine Director of Catchment Area Research - Hillman Cancer Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Margaret Q Rosenzweig

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh School of Nursing

Locations

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

HCC 20-243

Identifier Type: -

Identifier Source: org_study_id