Nurse AMIE: Addressing Metastatic Individuals Everyday

NCT03975621 | Completed

• 1 other identifier: STUDY00011444
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the acceptability and feasibility of a supportive care software platform to improve quality of life and function in metastatic breast cancer patients. Acceptability will be defined as the proportion of women offered the intervention who agree to participate. Feasibility will be defined as the proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.

Conditions

Metastatic Breast Cancer

Keywords

Exercise; Feasibility; Acceptability; Supportive Care Platform

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Application: The proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.

  Feasibility is defined as the proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.

  3 Months

Secondary Outcomes (1)

• Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.

  3 Months

Other Outcomes (6)

• Quality of Life: Short Form 36

  Through study completion, an average of 9 months

• Quality of Life: Functional Assessment of Cancer Therapy- Breast

  Through study completion, an average of 9 months

• Physical Function: Short Physical Performance Battery

  Through study completion, an average of 9 months

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

The immediate intervention group will receive the intervention at the time of consent (baseline) and will be enrolled in the intervention for a total of 6 months. Patients will receive the tablet, a pedometer and an exercise band. Patients will use Nurse AMIE while receiving weekly phone calls from a patient navigator. After 90 days of the intervention observation will take place for 90 days, the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.

Behavioral: Supportive Care

Delayed Intervention

EXPERIMENTAL

The delayed intervention group will receive the intervention 3 months after consent (6 months of intervention with 3 months delay total of 9 months); the patient will then follow the same pattern as listed above. The only difference is we will ask the delayed intervention group to wear a FitBit device for 1 week following consent in order to gain baseline data as to their activity/movement.

Behavioral: Supportive Care

Interventions

Supportive Care BEHAVIORAL

Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.

Delayed Intervention; Immediate Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with metastatic breast cancer
• ECOG performance score ≤3.
• English Speaking
• With sufficient vision/hearing or family support
• Willingness to be randomized

You may not qualify if:

• Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
• Patients who are receiving any other behavioral intervention

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kathryn H Schmitz, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Public Health Sciences

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 5, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)