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Clinical Trials/NCT05409664
NCT05409664Active, not recruitingNot Applicable

Peer Coaching for Physical Activity Promotion Among Breast Cancer Survivors: Adapting an Efficacious Intervention to Prepare for Implementation

University of South Carolina2 sites in 1 country68 target enrollmentStarted: November 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
68
Locations
2
Primary Endpoint
Accelerometer measured moderate-to-vigorous activity

Study Overview

Brief Summary

This is a 3-month physical activity intervention aimed to increase moderate-intensity activity among previously inactive breast cancer survivors. Participants will be eligible if they are not currently active, and have recently been diagnosed with breast cancer. Upon eligibility, participants will be randomized into one of two groups. The intervention group will receive weekly guidance from a peer coach to increase their activity throughout the three month intervention. The control group will be encouraged to self-monitor their physical activity throughout the three month intervention. Both groups will receive a Fitbit. Peer coaches will be trained to deliver the physical activity program using a web-based platform; all calls will be virtual. Participants will be assessed before and after the intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Diagnosed in the past 5 years with Stage 0-3 breast cancer
  • Able to read and speak English
  • Ambulatory
  • Sedentary (<30 minutes of vigorous-intensity physical activity, <90 min of moderate-intensity physical activity in the past 6 months)
  • Able to walk unassisted
  • Access to a smartphone with Bluetooth and internet

Exclusion Criteria

  • Stage 4 cancer
  • Medical or psychiatric problem that may interfere with protocol adherence
  • Peer Mentor Coaches:
  • Inclusion criteria:
  • Current peer coach (at least one year)
  • Have a valid email address, telephone access, and access to a tablet/computer
  • Willing to participate in group training
  • Willing to be supervised using platform
  • Currently exercise for at least 60 min/week of moderate-intensity activity

Outcomes

Primary Outcomes

Accelerometer measured moderate-to-vigorous activity

Time Frame: 3-month intervention

Minutes of moderate-to-vigorous intensity activity at 3-month follow-up

Secondary Outcomes

  • Self-Reported Quality of Life(Pre-intervention and post 3-month intervention)
  • Self-Reported Physical Functioning(Pre-intervention and post 3-month intervention)
  • Self-Reported Fatigue(Pre-intervention and post 3-month intervention)
  • Self-Reported Mood(Pre-intervention and post 3-month intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bernardine Pinto

Associate Dean for Research

University of South Carolina

Study Sites (2)

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