Trial Title:
Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
NCT ID:
NCT05931874
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
e-health
physical activity
mindfulness
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Intervention model description:
The four Intervention components that are candidates for inclusion in the optimized
intervention, each with 2 possible levels, will be tested in a 24-week intervention with
a 24-week follow-up using a MOST approach. The effects of the four individual
intervention components and their combinations will be examined via a full factorial
experiment. The investigators chose a factorial experimental design because these designs
have two characteristics essential to the success of MOST. They: a) separate component
effects enabling the estimation of the main effect of each candidate component and
interactions between components and b) are more economical compared to alternative
designs because they often require substantially fewer subjects to achieve the same power
and use less resources. The investigators are using a full factorial experiment with
2^4=16 experimental conditions.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Core Intervention
Description:
All participants will receive a low-resource self-monitoring intervention consisting of
the Fitbit Alta HR (or similar) and the study self-monitoring app.
Participants will be provided with the Fitbit Alta HR. They will be asked to download the
Fitbit app and wear the Fitbit 24/7 throughout the study. The Fitbit measures PA
intensity, steps, and heart rate, and it syncs directly with the Ftibit app on the
smartphone which will ill automatically sync with the study app and provide Fitbit data
to the study team in real-time.
The core study app will support BCS to increase their MVPA. The app will also contain
educational information on MVPA and effective behavior change strategies for building
self-efficacy, overcoming barriers, enhancing facilitators, setting realistic outcome
expectations, and self-regulatory skill-building (i.e., reviewing progress, goal setting,
action-planning and coping with disruptions).
Arm group label:
Exp Condition 1
Arm group label:
Exp Condition 10
Arm group label:
Exp Condition 11
Arm group label:
Exp Condition 12
Arm group label:
Exp Condition 13
Arm group label:
Exp Condition 14
Arm group label:
Exp Condition 15
Arm group label:
Exp Condition 16
Arm group label:
Exp Condition 2
Arm group label:
Exp Condition 3
Arm group label:
Exp Condition 4
Arm group label:
Exp Condition 5
Arm group label:
Exp Condition 6
Arm group label:
Exp Condition 7
Arm group label:
Exp Condition 8
Arm group label:
Exp Condition 9
Intervention type:
Behavioral
Intervention name:
E-Coach
Description:
Participants assigned to this condition will receive a weekly scheduled text message from
their coach. Text messages will focus on building self-efficacy and self-regulation
skills, setting realistic outcome expectations, overcoming barriers, and problem-solving
and will directly support the participant's engagement in the intervention. The coach
will provide a brief overview of the participant's recent progress and goals, ask if they
are having any barriers and help them troubleshoot and set specific goals for the next
week. Text message protocols will be informed by the investigators' previous experience
using telephone coaching to promote MVPA in cancer survivors. In addition to the
scheduled messaging, participants will also be instructed to reach out to their coach
with any questions or for additional assistance.
Arm group label:
Exp Condition 1
Arm group label:
Exp Condition 2
Arm group label:
Exp Condition 3
Arm group label:
Exp Condition 4
Arm group label:
Exp Condition 5
Arm group label:
Exp Condition 6
Arm group label:
Exp Condition 7
Arm group label:
Exp Condition 8
Intervention type:
Behavioral
Intervention name:
Buddy
Description:
Participants assigned to this condition will select a buddy of their choice (i.e. friend,
co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share
their Fitbit data with the study team. The buddy will be mailed a Fitbit, share their
Fitbit data with the study team, and be provided with access to, and instructions for,
all of the study app modules the participant has access to for their assigned condition.
The study app include a buddy module where the buddy and participant can view each
other's progress. The buddy will be expected to attend a 15-30 minute group orientation
call and listen to four 10-15 minute podcast (one every 3 weeks) during the first 24
weeks of the intervention. Each webinar will provide social support training and peer
discussion of challenges and successes in providing BCS with MVPA support.
Arm group label:
Exp Condition 1
Arm group label:
Exp Condition 11
Arm group label:
Exp Condition 13
Arm group label:
Exp Condition 15
Arm group label:
Exp Condition 3
Arm group label:
Exp Condition 5
Arm group label:
Exp Condition 7
Arm group label:
Exp Condition 9
Intervention type:
Behavioral
Intervention name:
General Mindfulness Training
Description:
Participants assigned to this condition will be instructed to watch 1 (1-2 mins),
mindfulness education videos each week which lay the foundation for what mindfulness is
and how it can be an important health behavior. Each week participants will also be asked
to listen to general guided mindfulness audio files ≥5 days/ week. The length of
recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and
recording will be available via the study app.
Arm group label:
Exp Condition 1
Arm group label:
Exp Condition 10
Arm group label:
Exp Condition 13
Arm group label:
Exp Condition 14
Arm group label:
Exp Condition 2
Arm group label:
Exp Condition 5
Arm group label:
Exp Condition 6
Arm group label:
Exp Condition 9
Intervention type:
Behavioral
Intervention name:
MVPA-Specific Mindfulness Training
Description:
Participants assigned to the MVPA-specific mindfulness training component will be
instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which
lay the foundation for what mindfulness is and the importance of linking mindful
awareness with MVPA. Each week participants will be provided access to MVPA-specific
guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute
bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week.
The length and intensity of these audio files will correspond to their progression in the
program. All videos and recordings will be accessed via the study app.
Arm group label:
Exp Condition 1
Arm group label:
Exp Condition 11
Arm group label:
Exp Condition 12
Arm group label:
Exp Condition 13
Arm group label:
Exp Condition 14
Arm group label:
Exp Condition 2
Arm group label:
Exp Condition 7
Arm group label:
Exp Condition 8
Summary:
The primary purpose of the present study is to apply MOST methodology to determine which
types of social support and mindfulness training intervention components optimally
increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week
intervention with a 48-week follow-up. The researchers will also examine the effects of
changes in MVPA on symptom burden, time spent in intensities of other activities (i.e.
light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for
inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence
additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue,
depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary
time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as
post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators
(i.e., age, time since diagnosis) of the four intervention components on MVPA.
Detailed description:
The primary purpose of the present study is to apply MOST methodology to determine which
types of social support and mindfulness training intervention components optimally
increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week
intervention with a 48-week follow-up. The researchers will also examine the effects of
changes in MVPA on symptom burden, time spent in intensities of other activities (i.e.
light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for
inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence
additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue,
depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary
time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as
post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators
(i.e., age, time since diagnosis) of the four intervention components on MVPA.
Research participants will be identified and recruited at Robert H. Lurie Cancer Center
(RHLCC) at Northwestern University (NU). All BCS and Buddies will complete an initial
10-15 minute eligibility screening online, over the phone, or in-person. The study RA
will obtain informed consent and HIPAA authorization from eligible participants according
to IRB approved procedures.
Assessments. After informed consent completion, the NU study team will send participants
an email with an individual, secure link to study questionnaires and notification that an
ActiGraph accelerometer packet has been mailed. Participants will be asked to complete
the questionnaire within 1 week of receipt. BCS will be provided with detailed written
instructions for how to wear the ActiGraph.
Randomization and Study Orientation. After completing baseline assessments, BCS will be
randomized to each group using computer-generated randomly permuted blocks. After
randomization, the NU study team will send the participant an intervention packet which
will include the Fitbit, Fitbit instructions, instructions and a QR code to download the
study app, and instructions specific to each condition to which they are assigned. The
participant will also be scheduled for an orientation phone or web call with study staff
to go over the contents of the intervention packet and expectations of participation for
each component in greater detail.
Intervention Components
Core Intervention (Fitbit + Study App). All participants will receive a low-resource
self-monitoring intervention consisting of the Fitbit AltaHR (or similar) and the study
self-monitoring app. Participants will be asked to download the Fitbit app and wear the
Fitbit 24/7 throughout the 48-week study period. The core study app will support BCS to
increase their MVPA. Participants will be provided with a weekly MVPA goal to build
efficacy and ensure safe progression towards the overall goal of 150 minutes per week.
Participants will be instructed to self-monitor progress towards these goals via feedback
on Fitbit Alta HR and the daily, weekly and monthly progress information provided in the
study app.
Buddy. Participants assigned to this condition will select a buddy of their choice (i.e.
friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to
share their Fitbit data with the study team. The study team will reach out to the buddy
via an email containing a description of the expectations of the buddy and a link to
complete online screening. The buddy will be mailed a Fitbit, share their Fitbit data
with the study team, and be provided with access to, and instructions for, all of the
study app modules the participant has access to for their assigned condition. The buddy
will be expected to attend a 15-minute group orientation call online and to listen to
four 10-15 minute podcasts (one every 3 weeks) during the 24 week intervention. Each
webinar will provide social support training and peer discussion of challenges and
successes in providing BCS with MVPA support.
E-coaching. Participants assigned to this condition will receive a weekly scheduled text
message from their coach. Text messages will focus on building self-efficacy and
self-regulation skills, setting realistic outcome expectations, overcoming barriers, and
problem-solving and will directly support the participant's engagement in the
intervention. The coach will provide a brief overview of the participant's recent
progress and goals, ask if they are having any barriers and help them troubleshoot and
set specific goals for the next week. In addition to the scheduled messaging,
participants will also be instructed to reach out to their coach with any questions or
for additional assistance. The coach will respond within 24 hours (weekdays) to 48 hours
(weekends), maximum.
General Mindfulness Training. Participants assigned to this condition will be instructed
to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation
for what mindfulness is and how it can be an important health behavior. Each week
participants will also be asked to listen to general guided mindfulness audio files ≥5
days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30
minutes. All videos and recording will be available via the study app.
MVPA-Specific Mindfulness Training. Participants assigned to the MVPA-specific
mindfulness training component will be instructed to watch 1-2 brief (1-2 minute),
mindfulness education videos each week which lay the foundation for what mindfulness is
and the importance of linking mindful awareness with MVPA. Each week participants will be
provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute
treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to
listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files
will correspond to their progression in the program. All videos and recording will be
accessed via the study app.
Follow-up. Participants will be instructed to maintain their MVPA during the 24-week
follow-up period. They will have access to all materials to which they were assigned to
less any direct contact from the study team.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
For BCS
- Female, age 18 years or older
- Stage I-III breast cancer diagnosis within the past 5 years
- Diagnosis of cancer between 18-39 years and within the past 5 years
- ≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or
radiation); may still be undergoing endocrine or hormone therapies
- Self-report engagement in <60 min/week of MVPA
- Score of 0 on all positive statement(s) of the Physical Activity Readiness
Questionnaire (PAR-Q)18 or willingness to obtain medical clearance from a primary
care physician or oncologist
- Internet access and smartphone ownership
- Fluency in spoken and written English
- Willingness to find a buddy (someone who knows about their cancer and participation
in this study and who is willing to participate by supporting them during the
24-week study), if assigned to that condition
For "Buddies"
- Friend, co-worker, caregiver or family member of a participating BCS
- Age 18 years or older
- Score of 0 on all positive statement(s) of the Physical Activity Readiness
Questionnaire (PAR-Q)18 or willing to obtain medical clearance from a primary care
physician
- Internet access and smartphone ownership
- Fluency in spoken and written English
- Willingness to share their Fitbit data with the study team
Exclusion Criteria:
- Absolute contraindications to exercise (i.e., acute myocardial infarction, severe
orthopedic conditions), metastatic disease, or planned elective surgery
- Currently pregnant or plans to become pregnant
- Plans to move out of the United States in next 18 months
- Current enrollment in another dietary or physical activity trial
- Inability to provide informed consent
- Prisoners or other detained individuals
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Siobhan M Phillips, PhD, MPH
Phone:
312-503-4235
Email:
smphillips@northwestern.edu
Contact backup:
Last name:
David E Victorson, PhD
Phone:
847-467-3060
Email:
d-victorson@northwestern.edu
Start date:
March 24, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05931874
