Clinical trial NCT05931874: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
Official title: Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
e-health
physical activity
mindfulness
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-07-05
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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

Brief 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.

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

Primary outcomes:
measure: Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
timeFrame: 48 weeks
Secondary outcomes:
measure: Anxiety in breast cancer survivors
timeFrame: 48 weeks
measure: Depression in breast cancer survivors
timeFrame: 48 weeks
measure: Fatigue in breast cancer survivors
timeFrame: 48 weeks
measure: Physical Function in breast cancer survivors
timeFrame: 48 weeks
measure: Sleep Disturbance in breast cancer survivors
timeFrame: 48 weeks
measure: Sleep Impairment in breast cancer survivors
timeFrame: 48 weeks
measure: Applied Cognition Abilities in breast cancer survivors
timeFrame: 48 weeks
measure: Emotional Support in breast cancer survivors
timeFrame: 48 weeks
measure: Self-Esteem in breast cancer survivors
timeFrame: 48 weeks
measure: Social support for exercise in breast cancer survivors
timeFrame: 48 weeks
measure: Physical self-perception in breast cancer survivors
timeFrame: 48 weeks
measure: Enjoyment of Physical Activity in young adult cancer survivors
timeFrame: 48 weeks
measure: Leisure Time Physical Activity in breast cancer survivors
timeFrame: 48 weeks
measure: Confidence in ability to be regularly active in breast cancer survivors
timeFrame: 48 weeks
measure: Confidence in ability to be regularly active despite common barriers in breast cancer survivors
timeFrame: 48 weeks
measure: Exercise goal setting in breast cancer survivors
timeFrame: 48 weeks
measure: Sitting time in breast cancer survivors
timeFrame: 48 weeks
measure: Outcome expectations for exercise in breast cancer survivors
timeFrame: 48 weeks
measure: Mindful Awareness in breast cancer survivors
timeFrame: 48 weeks
measure: Mindful self-compassion in breast cancer survivors
timeFrame: 48 weeks
measure: Post-traumatic growth in breast cancer survivors
timeFrame: 48 weeks
measure: Implementation feasibility measured by enrollment rate
timeFrame: 48 weeks
measure: Implementation feasibility measured by retention rate
timeFrame: 48 weeks
measure: Adherence to the study app + Fitbit by breast cancer survivors
timeFrame: 48 weeks
measure: Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey
timeFrame: 48 weeks
measure: Change in body mass index in breast cancer survivors
timeFrame: 48 weeks
measure: Change in health behaviors in breast cancer survivors
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Siobhan M Phillips, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: David E Victorson, PhD
role: PRINCIPAL_INVESTIGATOR
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