Apollo Device for Metastatic Breast Cancer (MBC)

NCT04983342 | Completed DMC

• 1 other identifier: HCC 20-243
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Fatigue; Metastatic Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Change in Fatigue (PROMIS-Fatigue)

  Change from baseline to 4 and then 8 weeks as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue scale, which measures the presence of fatigue and its interference with life. PROMIS-Fatigue includes 6 items with scores 1-5 for each item, total scores 6-30. Lower scores indicate less fatigue and interference from fatigue.

  Up to 8 weeks

• Change in Fatigue (FACT-F)

  Change from baseline to 4 and then 8 weeks as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item, 5 choice/item measure ranging from 0 (Not at all) to 4 (Very much) that assesses self-reported fatigue and its impact upon daily activities and function, 0-160 is the total score with higher scores indicating better QOL, the lower the fatigue symptoms. The recall period refers to the "past 7 days".

  Up to 8 weeks

Secondary Outcomes (5)

• Degree of Pain

  Up to 8 weeks

• Use of pain medications

  Up to 8 weeks

• Health Related quality of life (HRQOL)

  Up to 8 weeks

• Promis Sleep Measurement

  Up to 8 weeks

• Hospital Anxiety and Depression Scale (HADS)

  Up to 8 weeks

Study Arms (1)

Apollo Armband

EXPERIMENTAL

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.

Device: Apollo Armband

Interventions

Apollo Armband 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.

Apollo Armband

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Most MBC is among females - males are excluded due to lack of generalizability
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Margaret Quinn Rosenzweig: lead
• Apollo Neuroscience, Inc.: collaborator

Study Sites (1)

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Fatigue; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Margaret Q Rosenzweig

  University of Pittsburgh School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Distinguished Service Professor of Nursing, Professor of Medicine Director of Catchment Area Research - Hillman Cancer Center

Model Details: Single-arm pilot design -pre and post

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 30, 2021
• Study Start: February 1, 2021
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months following last patient accrual.

Locations

US (1)