Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors

Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05931874

Acronym

F2TMind

Enrollment

304

Registered

2023-07-05

Start date

2024-03-24

Completion date

2027-08-31

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, e-health, physical activity, mindfulness

Brief summary

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.

Interventions

BEHAVIORALCore Intervention

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).

BEHAVIORALE-Coach

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.

BEHAVIORALBuddy

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.

BEHAVIORALGeneral 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.

BEHAVIORALMVPA-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 recordings will be accessed via the study app.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

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.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors	48 weeks	Physical activity will be measured at baseline, 24 and 48 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). Minutes of moderate and vigorous physical activity will be used to assess change.

Secondary

Measure	Time frame	Description
Anxiety in breast cancer survivors	48 weeks	Symptom burden of anxiety will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a.
Depression in breast cancer survivors	48 weeks	Symptom burden of depression will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a.
Fatigue in breast cancer survivors	48 weeks	Symptom burden of fatigue will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a.
Physical Function in breast cancer survivors	48 weeks	Physical function will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Physical Function - Short Form 20a.
Sleep Disturbance in breast cancer survivors	48 weeks	Symptom burden of sleep disturbance will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Sleep Disturbance - Short Form 8a.
Sleep Impairment in breast cancer survivors	48 weeks	Symptom burden of sleep disturbance will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a.
Applied Cognition Abilities in breast cancer survivors	48 weeks	Symptom burden on applied cognitive abilities will be measured at baseline, 24 and 48 weeks using the PROMIS v1.0-Applied Cognition-Abilities-Short Form 8a.
Leisure Time Physical Activity in breast cancer survivors	48 weeks	Leisure time physical activity will be measured at baseline, 24 and 48 weeks using the Godin Leisure Time Exercise Questionnaire Physical Activity. This is a measure of self-reported physical activity participation. Participants report "times per week" they participate in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and the "average duration each time you exercised (in minutes)" for each of the three activity categories. Weekly minutes of total, light, moderate, and vigorous activity are calculated by multiplying the frequency and time of each activity. This value is divided by 7 to obtain daily averages. The minimum value one can score is 0, and the maximum depends on the number of self-reported minutes of physical activity. Higher scores indicate better outcome.
Light Intensity Physical Activity	48 weeks	Light intensity physical activity will be measured at baseline and at 24 and 48 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Sedentary Time	48 weeks	Sedentary time will be measured at baseline and at 24 and 48 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Sleep Duration	48 weeks	Sleep duration will be measured at baseline and at 24 and 48 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days on their wrist while they sleep.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSiobhan M Phillips, PhD, MPH

Northwestern University

PRINCIPAL_INVESTIGATORDavid E Victorson, PhD