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

Breast Cancer Clinical Trial

— F2TMind  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931874
• Other study ID #: NU 22CC05
• Secondary ID: R01CA266178
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Siobhan M Phillips, PhD, MPH
• Phone: 312-503-4235
• Email: smphillips[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Core 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).
• E-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.
• 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 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.
• 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 recordings will be accessed via the study app.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors	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.	48 weeks
Secondary	Anxiety in breast cancer survivors	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.	48 weeks
Secondary	Depression in breast cancer survivors	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.	48 weeks
Secondary	Fatigue in breast cancer survivors	Symptom burden of fatigue will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a.	48 weeks
Secondary	Physical Function in breast cancer survivors	Physical function will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Physical Function - Short Form 20a.	48 weeks
Secondary	Sleep Disturbance in breast cancer survivors	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.	48 weeks
Secondary	Sleep Impairment in breast cancer survivors	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.	48 weeks
Secondary	Applied Cognition Abilities in breast cancer survivors	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.	48 weeks
Secondary	Emotional Support in breast cancer survivors	Symptom burden on emotional support will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v2.0 - Emotional Support.	48 weeks
Secondary	Self-Esteem in breast cancer survivors	Symptom burden on self-esteem will be measured at baseline, 24 and 48 weeks using the Rosenberg Self-Esteem Scale.; This scale assesses global self-esteem and consists of 10-items asking participants to indicate their level of agreement/disagreement with each statement. Sample items include: "I feel that I'm a person of worth, at least on an equal basis with others;" and "I am able to things as well as most people." Participants respond on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The minimum value one can score is 10, and the maximum is 50. Higher scores indicate a better outcome.	48 weeks
Secondary	Social support for exercise in breast cancer survivors	Social support for exercise will be measured at baseline, 24 and 48 weeks using the Social Support for Exercise Scale.; This scale assesses support for physical activity received from the following categories: family, friends, and other cancer survivors. Statements are scored on a Likert scale of 1 (never) to 5 (very often) for each of the three categories, with higher scores representing better outcome. The minimum value one can score for each category is 10, and the maximum is 50. The minimum value of the total measure is 30, and the maximum is 150. An additional "does not apply" response option is provided on the measure.	48 weeks
Secondary	Physical self-perception in breast cancer survivors	Physical Self-Perception will be measured at baseline, 24 and 48 weeks using the Physical Self-Perception Profile-Physical Self-worth Subscale.; This instrument used to assess self-esteem relative to several domains of physical functioning in a hierarchical, multidimensional fashion. The instrument contains a general physical self-worth scale (PSW) which subsumes four more specific scales of perceived sport competence (SPORT), physical condition (COND), attractive body (BODY), and strength (STRENGTH), with six items per scale. Participants indicated on a four-point scale the degree to which each item is characteristic or true of them. Responses range from 1 (not at all true) to 4 (completely true), with higher scores representing better outcome. The minimum value one can score is 6, and the maximum is 24.	48 weeks
Secondary	Enjoyment of Physical Activity in young adult cancer survivors	Enjoyment of Physical Activity will be measured at baseline, 24 and 48 weeks using the Physical Activity Enjoyment Scale.; This 18-item scale assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7 point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items are negatively worded and seven items are positively worded. After reverse scoring the 11 negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a value range of 18-126 being possible. Higher scores indicate higher enjoyment, better outcome.	48 weeks
Secondary	Leisure Time Physical Activity in breast cancer survivors	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.	48 weeks
Secondary	Confidence in ability to be regularly active in breast cancer survivors	Confidence in ability to be regularly active will be measured at baseline, 24 and 48 weeks using the Exercise Self-Efficacy (EXSE).; This short form assesses the participants' beliefs in their ability to be regularly active "for the next 12 weeks" on a scale from 0% (not at all confident) to 100% (completely confident), with higher scores representing better outcome.	48 weeks
Secondary	Confidence in ability to be regularly active despite common barriers in breast cancer survivors	Confidence in ability to be regularly active despite common barriers will be measured at baseline, 24 and 48 weeks using the Barries Self-Efficacy (BARSE).; This scale assesses the beliefs in ability to be regularly active despite common barriers "for the next 12 weeks" on a scale from 0% (not at all confident) to 100% (completely confident), with higher scores representing better outcome.	48 weeks
Secondary	Exercise goal setting in breast cancer survivors	Exercise goal setting in breast cancer survivors will be measured at baseline, 24 and 48 weeks using the Exercise Goal Setting Scale.; This scale assesses exercise goal setting behaviors on a scale from 1 (does not describe) to 5 (describes completely), with higher scores representing better outcome.	48 weeks
Secondary	Sitting time in breast cancer survivors	Sitting time in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Sitting Time Questionnaire.; This questionnaire assesses the amount of hours and minutes spent sitting during weekdays and weekends, with lower scores representing better outcome.	48 weeks
Secondary	Outcome expectations for exercise in breast cancer survivors	Outcome expectations for exercise in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Outcome Expectations for Exercise_MOEES.; This scale assesses the beliefs and expectations about the benefits of regular exercise and physical activity on a scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores representing better outcome.	48 weeks
Secondary	Mindful Awareness in breast cancer survivors	Mindful awareness of distressing thoughts and images will be measured at baseline, 24 and 48 weeks using the Southampton Mindfulness Questionnaire (SMQ).; This 16-item scale measures mindful awareness during distressing thoughts and images. Using a 7-point Likert scale (0=strongly disagree to 6=strongly agree), items reflect the following subscales: mindful observation (4 items), letting go (4 items), non- aversion (4 items), and non-judgment (4 items). The minimum value one can score on any of the subscales is 0, and the maximum is 24. The minimum value of the total measure is 0, and the maximum is 96. The higher scores represent better outcome.	48 weeks
Secondary	Mindful self-compassion in breast cancer survivors	Mindful self-compassion will be measured at baseline, 24 and 48 weeks using the Self-Compassion Short Form.; This short form is a 12-item scale measuring items related to self-kindness, self-judgment, and common humanity. Statements on the Self-Compassion Scale are scored on a Likert scale of 1 (almost never) to 5(almost always). To calculate an overall compassion score - Items representing uncompassionate responses to inadequacy or suffering (the self-judgment, isolation, and over-identification subscales) are reverse-coded only when calculating the overall compassion score. In this way, higher scores represent a lower frequency of these responses.	48 weeks
Secondary	Post-traumatic growth in breast cancer survivors	Post-traumatic growth will be measured at baseline, 24 and 48 weeks using the Post-traumatic Growth Inventory.; This 21-item self-report scale assesses growth or benefits after a specific traumatic life event. The Post Traumatic Growth Inventory (PTGI) is scored by adding all the responses, with higher scores representing better outcome.	48 weeks
Secondary	Implementation feasibility measured by enrollment rate	This indicator of implementation feasibility for the interventions delivered is defined by the overall enrollment rate being >/= 70% (e.g., total number of individuals enrolled/total number approached). Enrollment rate will be tracked continuously during the 48 week study.	48 weeks
Secondary	Implementation feasibility measured by retention rate	This indicator of implementation feasibility for the interventions delivered is defined by the retention rate being >/= 70% (e.g., total number of participants who drop out/ total number randomized). Retention rate will be tracked continuously during the 48 weeks of the study and significant differences between the study interventions in the number of participant withdrawals will be tracked.	48 weeks
Secondary	Adherence to the study app + Fitbit by breast cancer survivors	Adherence to the study app + Fitbit will be monitored and usage tracked continuously during the 48 week study.; Objective data include Fitbit wear time, number of times app is opened each week, time spent in app each time it is opened, and for participants who receive each component, usage of general and moderate to vigorous intensity physical activity specific mindfulness videos (i.e. whether clicked, how many times and for how long), number of e-coaching exchanges, number of buddy training webinars attended, and number of buddy interactions in the app.	48 weeks
Secondary	Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey	Acceptability will be measured using a brief, Likert-type survey assessing participant enjoyment, satisfaction, perceived benefit, and ease of use. Acceptability is defined as >/= 70% of survey responses in affirmation of this.	48 weeks
Secondary	Change in body mass index in breast cancer survivors	Change in body mass index in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Health History Questionnaire, a local questionnaire developed by the study researchers.; Participants will report on the following: height and most recent weight. BMI will be calculated. Significant change will be indicated by p<.05 on reported health behaviors between baseline and follow up time points between study interventions.	48 weeks
Secondary	Change in health behaviors in breast cancer survivors	Change in health behaviors in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Health History Questionnaire, a local questionnaire developed by the study researchers.; Participants will report on the following: weekly leisure-time physical activities; weekly consumption of fruits, vegetables, fast food/snacks, caffeine, carbonated beverages; cigarette and alcohol use. Unhealthy behaviors will be reverse scored. Higher scores represent better outcome. Significant change will be indicated by p<.05 on reported health behaviors between baseline and follow up time points between study interventions.	48 weeks