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Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)

Primary Purpose

Breast Cancer, Cancer of the Breast

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Intervention
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring prehabilitation, physical activity, cancer-related cognitive decline, telehealth, physical therapy, survivorship, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Eligibility Criteria: Diagnosis of breast cancer (stage I-III). Female. At least 18 years old. Scheduled to receive curative-intent chemotherapy. English speaking. Deemed fit to participate in a PA intervention by their oncologist. Not currently participating in another physical activity research study. Low active, defined by self-report as no more than 2 times per week of regular physical activity in the last six months Able to understand and willing to sign an IRB-approved written informed consent document.

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Activity Intervention

Usual care, wait-list control condition

Arm Description

Participants will complete a primarily home-based PA intervention, with the goal of safely increasing their steps/day by incorporating moderate-to-vigorous physical activity (MVPA) Participants will receive Fitbits with heart rate capabilities to support maintenance of the prescribed intensity during home exercise sessions and participants' self-monitoring of daily steps. Participants will strategize aerobic MVPA behaviors with the intervention PT to identify preferable and enjoyable PA modalities (e.g., walking, cycling), while also identifying alternative options to allow for flexibility if life- or cancer-specific barriers arise During the first Zoom coaching session, the intervention PT will train participants on using the Fitbit and completing home exercise logs. The PT will continue to meet with participants to support exercise maintenance, review home exercise sessions, strategize new exercises, and troubleshoot emerging chemotherapy-related health declines.

-Participants in the control group will proceed with their treatment regimen as prescribed by their oncologist(s). To prevent drop out and high attrition rates as well as promote healthy behavior, control group participants will receive a Fitbit at the initial set-up meeting to wear during chemotherapy, as well as an individualized home exercise program and up to two Zoom coaching sessions with a PT after chemotherapy completion.

Outcomes

Primary Outcome Measures

Changes in self-reported cognition function as measured by FACT-Cog
The FACT-Cog examines a range of self-reported cognitive domains, including perceived cognitive impairment (PCI, range 0-71), perceived cognitive abilities (PCA, range 0-28), impact of cognitive impairment on quality of life (CogQOL, range 0-16), cognitive impairment perceived by others (CogOth, range 0-16), and a total cognitive functioning score (the sum of the other 4 subscales). Higher scores indicate fewer cognitive difficulties.
Feasibility of the intervention as measured by Feasibility of Intervention Measure (FIM)
The FIM measures the degree to which a participant feels an intervention is feasible to them. It ranges from 4-20, and higher scores indicate more feasibility. We will use a cutoff of 16 to indicate "feasible"

Secondary Outcome Measures

Changes in objective measures of cognition function as measured by BrainBaseline Spatial Working Memory
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to hold information about an object's location in short term memory. Overall accuracy is the primary measure of performance. Accuracy ranges from 0-100%. Higher accuracy scores represent better accuracy.
Changes in objective measures of cognition function as measured by BrainBaseline N-back
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to retain sequentially presented information in short-term memory. Overall accuracy is considered the primary measure of performance. Accuracy ranges from 0-100%. Higher accuracy scores represent better accuracy.
Changes in objective measures of cognition function as measured by BrainBaseline Flanker
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to focus attention and block irrelevant information. Task performance is assessed by observing reaction time cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction times represent slower reaction time.
Changes in objective measures of cognition function as measured by BrainBaseline Trails A&B
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to connect-the-dots, drawing a line between targets in a specified ascending order. Task performance is assessed by observing time to completion. A higher time to completion represents a slower ability to connect-the-dots.
Changes in objective measures of cognition function as measured by BrainBaseline Stroop
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to focus attention on a particular stimulus dimension while ignoring another. Task performance is assessed by observing the reaction time cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction time scores represent slower reaction time.
Changes in objective measures of cognition function as measured by BrainBaseline Task switching
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to switch between two separate tasks. The primary outcome measure is switch cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction time scores represent slower reaction time.
Changes in objective measures of cognition function as measured by BrainBaseline Digit Symbol Substitution
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to quickly and precisely shift attention from location to another, as well as measuring motor skill. The primary outcome measure is the number of correct substitutions made within the 90-second limit.
Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
The AIM measures the degree to which a participant feels an intervention is acceptable to them. It ranges from 4-20, and higher scores indicate more acceptability. The investigators will use a cutoff of 16 to indicate "acceptable"
Appropriateness of the intervention as measured by the Intervention Appropriateness Measure (IAM)
The IAM measures the degree to which a participant feels an intervention is appropriate for them. It ranges from 4-20, and higher scores indicate more appropriateness. The investigators will use a cutoff of 16 to indicate "appropriate"
Adherence of the intervention as measured by percentage of home exercise sessions and PT telehealth appointments completed

Full Information

First Posted
January 17, 2023
Last Updated
May 15, 2023
Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05716542
Brief Title
Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)
Official Title
Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators propose to deliver a pilot randomized controlled trial to 40 women newly diagnosed with breast cancer and scheduled to undergo chemotherapy. The current objectives are: 1) to evaluate the preliminary efficacy of the prehabilitation physical activity (PA) intervention delivered by a physical therapist and 2) assess the intervention's feasibility, acceptability, and appropriateness. The long-term goal is to scale this intervention for implementation into the standard of cancer care to prevent, mitigate, and treat cancer-related cognitive decline (CRCD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer of the Breast
Keywords
prehabilitation, physical activity, cancer-related cognitive decline, telehealth, physical therapy, survivorship, breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Intervention
Arm Type
Experimental
Arm Description
Participants will complete a primarily home-based PA intervention, with the goal of safely increasing their steps/day by incorporating moderate-to-vigorous physical activity (MVPA) Participants will receive Fitbits with heart rate capabilities to support maintenance of the prescribed intensity during home exercise sessions and participants' self-monitoring of daily steps. Participants will strategize aerobic MVPA behaviors with the intervention PT to identify preferable and enjoyable PA modalities (e.g., walking, cycling), while also identifying alternative options to allow for flexibility if life- or cancer-specific barriers arise During the first Zoom coaching session, the intervention PT will train participants on using the Fitbit and completing home exercise logs. The PT will continue to meet with participants to support exercise maintenance, review home exercise sessions, strategize new exercises, and troubleshoot emerging chemotherapy-related health declines.
Arm Title
Usual care, wait-list control condition
Arm Type
No Intervention
Arm Description
-Participants in the control group will proceed with their treatment regimen as prescribed by their oncologist(s). To prevent drop out and high attrition rates as well as promote healthy behavior, control group participants will receive a Fitbit at the initial set-up meeting to wear during chemotherapy, as well as an individualized home exercise program and up to two Zoom coaching sessions with a PT after chemotherapy completion.
Intervention Type
Other
Intervention Name(s)
Physical Activity Intervention
Intervention Description
Fitbit wearable device, home exercise sessions, and telehealth appointments with physical therapist.
Primary Outcome Measure Information:
Title
Changes in self-reported cognition function as measured by FACT-Cog
Description
The FACT-Cog examines a range of self-reported cognitive domains, including perceived cognitive impairment (PCI, range 0-71), perceived cognitive abilities (PCA, range 0-28), impact of cognitive impairment on quality of life (CogQOL, range 0-16), cognitive impairment perceived by others (CogOth, range 0-16), and a total cognitive functioning score (the sum of the other 4 subscales). Higher scores indicate fewer cognitive difficulties.
Time Frame
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Title
Feasibility of the intervention as measured by Feasibility of Intervention Measure (FIM)
Description
The FIM measures the degree to which a participant feels an intervention is feasible to them. It ranges from 4-20, and higher scores indicate more feasibility. We will use a cutoff of 16 to indicate "feasible"
Time Frame
After completion of intervention (estimated to be 12 weeks)
Secondary Outcome Measure Information:
Title
Changes in objective measures of cognition function as measured by BrainBaseline Spatial Working Memory
Description
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to hold information about an object's location in short term memory. Overall accuracy is the primary measure of performance. Accuracy ranges from 0-100%. Higher accuracy scores represent better accuracy.
Time Frame
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Title
Changes in objective measures of cognition function as measured by BrainBaseline N-back
Description
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to retain sequentially presented information in short-term memory. Overall accuracy is considered the primary measure of performance. Accuracy ranges from 0-100%. Higher accuracy scores represent better accuracy.
Time Frame
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Title
Changes in objective measures of cognition function as measured by BrainBaseline Flanker
Description
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to focus attention and block irrelevant information. Task performance is assessed by observing reaction time cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction times represent slower reaction time.
Time Frame
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Title
Changes in objective measures of cognition function as measured by BrainBaseline Trails A&B
Description
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to connect-the-dots, drawing a line between targets in a specified ascending order. Task performance is assessed by observing time to completion. A higher time to completion represents a slower ability to connect-the-dots.
Time Frame
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Title
Changes in objective measures of cognition function as measured by BrainBaseline Stroop
Description
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to focus attention on a particular stimulus dimension while ignoring another. Task performance is assessed by observing the reaction time cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction time scores represent slower reaction time.
Time Frame
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Title
Changes in objective measures of cognition function as measured by BrainBaseline Task switching
Description
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to switch between two separate tasks. The primary outcome measure is switch cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction time scores represent slower reaction time.
Time Frame
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Title
Changes in objective measures of cognition function as measured by BrainBaseline Digit Symbol Substitution
Description
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to quickly and precisely shift attention from location to another, as well as measuring motor skill. The primary outcome measure is the number of correct substitutions made within the 90-second limit.
Time Frame
Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Title
Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
Description
The AIM measures the degree to which a participant feels an intervention is acceptable to them. It ranges from 4-20, and higher scores indicate more acceptability. The investigators will use a cutoff of 16 to indicate "acceptable"
Time Frame
After completion of intervention (estimated to be 12 weeks)
Title
Appropriateness of the intervention as measured by the Intervention Appropriateness Measure (IAM)
Description
The IAM measures the degree to which a participant feels an intervention is appropriate for them. It ranges from 4-20, and higher scores indicate more appropriateness. The investigators will use a cutoff of 16 to indicate "appropriate"
Time Frame
After completion of intervention (estimated to be 12 weeks)
Title
Adherence of the intervention as measured by percentage of home exercise sessions and PT telehealth appointments completed
Time Frame
After completion of intervention (estimated to be 12 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria: Diagnosis of breast cancer (stage I-III). Female. At least 18 years old. Scheduled to receive curative-intent chemotherapy. English speaking. Deemed fit to participate in a PA intervention by their oncologist. Not currently participating in another physical activity research study. Low active, defined by self-report as no more than 2 times per week of regular physical activity in the last six months Able to understand and willing to sign an IRB-approved written informed consent document.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth A Salerno, Ph.D., MPH
Phone
314-362-4654
Email
e.salerno@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Salerno, Ph.D., MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Salerno, Ph.D., MPH
Phone
314-362-4654
Email
e.salerno@wustl.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth A Salerno, Ph.D., MPH
First Name & Middle Initial & Last Name & Degree
Lindsay Peterson, M.D., MSCR
First Name & Middle Initial & Last Name & Degree
Ryan Duncan, PT, DPT, MSCI
First Name & Middle Initial & Last Name & Degree
Maura Kepper, Ph.D.
First Name & Middle Initial & Last Name & Degree
Jingqin Luo, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)

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