Clinical trial NCT05409664: Moving Forward Together 4
Official title: Peer Coaching for Physical Activity Promotion Among Breast Cancer Survivors: Adapting an Efficacious Intervention to Prepare for Implementation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Physical Inactivity
Keywords: Peer support
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Brown University
name: InquisitHealth, Inc.
First posted: 2022-06-08
Enrollment: 68
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial. Participants will be randomly assigned to a intervention group or a control group. The study duration will be 3-months for both groups; assessments will be completed pre- and post-intervention.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Accelerometer measured moderate-to-vigorous activity
timeFrame: 3-month intervention
Secondary outcomes:
measure: Self-Reported Quality of Life
timeFrame: Pre-intervention and post 3-month intervention
measure: Self-Reported Physical Functioning
timeFrame: Pre-intervention and post 3-month intervention
measure: Self-Reported Mood
timeFrame: Pre-intervention and post 3-month intervention
measure: Self-Reported Fatigue
timeFrame: Pre-intervention and post 3-month intervention
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Bernardine M. Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References: