Pilot SMART of a Remotely Delivered, Adaptive Physical Activity Intervention for Breast Cancer Survivors
Purpose
The goal of this clinical trial is to evaluate the feasibility of randomizing
participants to a "step-up" intervention pathway when they perform <150 minutes of MVPA
at the 6-week data collection burst. Participants who performed <150 minutes of MVPA at
the 6-week data collection burst will be randomized to either continue with the standard
intervention or advance to the step-up intervention. The main questions it aims to answer
are:
1. What percentage of participants who are eligible for the intervention phase enroll
in the intervention phase?
2. Will participants assigned to the "step-up" intervention pathway demonstrate equal
or greater rates of study retention and intervention engagement relative to those
assigned to the standard intervention arm?
3. What percentage of the sample is performing >150 minutes accelerometer measured
MVPA/week at the intervention mid-point (week 6-data collection burst) and
end-of-study (week 12-data collection burst)?
4. Do at least 50% of participants assigned to the "step-up" intervention pathway
achieve a clinically meaningful volume of weekly MVPA by 12-weeks follow-up?
All participants will:
- Be assigned to either the Affect-based exercise prescription or the Effort-based
exercise prescription.
- Participate in three meetings with the interventionist (an exercise specialist)
meant to help them get started increasing weekly exercise. These meetings are the
same for all participants.
- Be asked to wear an activity monitor and respond to brief surveys for 10 consecutive
days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.
Some participants (those performing <150 minutes of MVPA at the 6-week data collection
burst) will be assigned to the step-up intervention pathway. Participants assigned to the
step-up intervention pathway will complete 3 additional follow-up meetings with the
interventionist. During these meetings, the interventionist will help participants
identify opportunities to be more active, set goals, and problem solve barriers to
action.
Condition
Eligibility
- Eligible Ages
-
Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
-
No
Inclusion Criteria
- ≥18 years old
- Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and
radiation) for Stage 0-III breast cancer
- <60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for
the past 6- months
- Own an Android or iPhone smartphone (or tablet) and willing to use it to complete
app-based surveys during assessment periods
- Willing to wear the ActiGraph monitor during assessment periods
- Access to internet to complete REDCap survey assessments
Exclusion Criteria
- Non-English speaking/not able to read English
- Evidence of major contraindications for exercise (informed by the 2020 Physical
Activity Readiness-Questionnaire (PAR-Q)+)
- Currently pregnant
- History of severe mental illness or currently taking mood stabilizing medications
(antipsychotics, anticonvulsants, or lithium)
- Evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the
Patient Health Questionnaire-8)
- Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a
6-item cognitive screener)
- Evidence of clinically significant substance use as indicated by a score of ≥ 2 on
the CAGE- AID screener.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|
Active Comparator
Effort-based Exercise Prescription (RPE-Rx) Standard
|
|
-
Behavioral: Standard Exercise Promotion Program
Core intervention content will be delivered during the Visit 1, 1-month, and
2-month-check-in meetings. Definitions of exercise will be provided, participants will be
asked to discuss their past experiences with exercise, guidelines for being safe during
exercise will be reviewed, and strategies for overcoming potential barriers to exercise
will be discussed. All participants will be given an exercise plan organized according to
the FIIT Principle (Frequency, Intensity, Time, and Type). The intensity component of the
exercise plan will differ by study arm, all other elements will be delivered the same for
all participants. All participants will be given the goal of increasing weekly time spent
exercising to ≥150 minutes, consistent with recommended guidelines. All participants will
be given a smartwatch to support self-monitoring of exercise and activity levels
throughout the 12-week study period.
|
Experimental
Affect-based Exercise Prescription (Affect-Rx) Standard
|
|
-
Behavioral: Affect-based Exercise Prescription
Participants assigned to Affect-Rx will receive instructions to "select a pace of
exercise that makes you feel as good as possible." The exercise intensity prescription
section of their exercise plan will include the Feeling Scale as an attachment and
participants will be given the instruction to "stay in the green zone" on the Feeling
Scale.
-
Behavioral: Standard Exercise Promotion Program
Core intervention content will be delivered during the Visit 1, 1-month, and
2-month-check-in meetings. Definitions of exercise will be provided, participants will be
asked to discuss their past experiences with exercise, guidelines for being safe during
exercise will be reviewed, and strategies for overcoming potential barriers to exercise
will be discussed. All participants will be given an exercise plan organized according to
the FIIT Principle (Frequency, Intensity, Time, and Type). The intensity component of the
exercise plan will differ by study arm, all other elements will be delivered the same for
all participants. All participants will be given the goal of increasing weekly time spent
exercising to ≥150 minutes, consistent with recommended guidelines. All participants will
be given a smartwatch to support self-monitoring of exercise and activity levels
throughout the 12-week study period.
|
Active Comparator
Effort-based Exercise Prescription (RPE-Rx) Step-Up
|
|
-
Behavioral: Effort-based exercise prescription
Participants assigned to RPE-Rx will receive instructions to "select a pace that would
make it challenging for you to carry on more than a short conversation." The exercise
intensity prescription section of their exercise plan will include the Rating of
Perceived Exertion (RPE) scale as an attachment and participants will be given the
instruction to "stay in the green zone" on the RPE Scale.
-
Behavioral: Standard Exercise Promotion Program
Core intervention content will be delivered during the Visit 1, 1-month, and
2-month-check-in meetings. Definitions of exercise will be provided, participants will be
asked to discuss their past experiences with exercise, guidelines for being safe during
exercise will be reviewed, and strategies for overcoming potential barriers to exercise
will be discussed. All participants will be given an exercise plan organized according to
the FIIT Principle (Frequency, Intensity, Time, and Type). The intensity component of the
exercise plan will differ by study arm, all other elements will be delivered the same for
all participants. All participants will be given the goal of increasing weekly time spent
exercising to ≥150 minutes, consistent with recommended guidelines. All participants will
be given a smartwatch to support self-monitoring of exercise and activity levels
throughout the 12-week study period.
-
Behavioral: Step-up Exercise Promotion Program
Core intervention content will be delivered during check-in meetings scheduled during
study weeks 7, 8, 9, and 10. During these visits, the interventionist will work with the
participant to set weekly goals and problem-solving barriers to action. All participants
will continue to receive instructions to follow their assigned exercise prescription
(Affect-based Exercise Prescription or Effort-based exercise prescription). The step-up
intervention calls are delivered the same regardless to which exercise prescription
format the participant is assigned.
|
Experimental
Affect-based Exercise Prescription (Affect-Rx) Step-Up
|
|
-
Behavioral: Affect-based Exercise Prescription
Participants assigned to Affect-Rx will receive instructions to "select a pace of
exercise that makes you feel as good as possible." The exercise intensity prescription
section of their exercise plan will include the Feeling Scale as an attachment and
participants will be given the instruction to "stay in the green zone" on the Feeling
Scale.
-
Behavioral: Standard Exercise Promotion Program
Core intervention content will be delivered during the Visit 1, 1-month, and
2-month-check-in meetings. Definitions of exercise will be provided, participants will be
asked to discuss their past experiences with exercise, guidelines for being safe during
exercise will be reviewed, and strategies for overcoming potential barriers to exercise
will be discussed. All participants will be given an exercise plan organized according to
the FIIT Principle (Frequency, Intensity, Time, and Type). The intensity component of the
exercise plan will differ by study arm, all other elements will be delivered the same for
all participants. All participants will be given the goal of increasing weekly time spent
exercising to ≥150 minutes, consistent with recommended guidelines. All participants will
be given a smartwatch to support self-monitoring of exercise and activity levels
throughout the 12-week study period.
-
Behavioral: Step-up Exercise Promotion Program
Core intervention content will be delivered during check-in meetings scheduled during
study weeks 7, 8, 9, and 10. During these visits, the interventionist will work with the
participant to set weekly goals and problem-solving barriers to action. All participants
will continue to receive instructions to follow their assigned exercise prescription
(Affect-based Exercise Prescription or Effort-based exercise prescription). The step-up
intervention calls are delivered the same regardless to which exercise prescription
format the participant is assigned.
|
Recruiting Locations
Dartmouth-Hitchcock Clinic
Lebanon,
New Hampshire
03756
More Details
- Status
- Recruiting
- Sponsor
- Dartmouth-Hitchcock Medical Center
Study Contact
Courtney J Stevens, PhD
6036509643
courtney.j.stevens@dartmouth.edu
Notice
Study information shown on this site is derived from
ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.