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临床试验/NCT05409664
NCT05409664进行中(未招募)不适用

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

University of South Carolina1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
68
试验地点
1
主要终点
Accelerometer measured moderate-to-vigorous activity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Participants:
  • •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

排除标准

  • •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

研究组 & 干预措施

webMFT

Experimental

Survivors randomized to webMFT will receive the evidence-based intervention for moderate-to-vigorous physical activity (MVPA) promotion that consists of MVPA counseling matched to patients' motivational readiness, and self-monitoring of MVPA (via Fitbit Inspire 2). The goal for the 3-month program will be to gradually increase the amount of moderate-intensity aerobic exercise that is performed, to the current national recommendations of at least 150 minutes of MPVA per week. Our goal is to promote aerobic exercise that is safe and enjoyable, such as walking.

干预措施: Physical activity adoption (Behavioral)

MVPA tracking

Active Comparator

These survivors will be asked to self-monitor moderate-to-vigorous physical activity (MVPA) participation by wearing the Fitbit Inspire 2 each day over 12 weeks. This group will not receive the MVPA counseling from the coaches.

干预措施: Self monitoring (Behavioral)

结局指标

主要结局

Accelerometer measured moderate-to-vigorous activity

时间窗: 3-month intervention

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bernardine Pinto

Associate Dean for Research

University of South Carolina

研究点 (1)

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