Breast Cancer Clinical Trial
— F2TMindOfficial title:
Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Cancer Institute (NCI) |
United States,
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* Note: There are 50 references in all — Click here to view all references
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 |
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