The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
280
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Northwestern University
Chicago, Illinois, United States
Adherence to a 12 Week Technology Supported Physical Activity Intervention
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Time frame: 12 weeks
Participant Retention
Percentage of participants retained at the end of the 12 week intervention of those randomized \[(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized\*100\].
Time frame: 12 weeks
Intervention Reach
Percentage of individuals randomized of those who were sent a study screening survey
Time frame: Baseline
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
Physical activity will be measured at baseline and at 12 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).
Time frame: Change from baseline to 12 weeks
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
Physical activity will be measured at baseline and at 24 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).
Time frame: Change from baseline to 24 weeks
Change in Fatigue From Before to After a 12-Week Intervention
Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 12 weeks
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 24 weeks
Change in Physical Function From Before to After a 12-Week Intervention
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 12 weeks
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off.
Time frame: Change from baseline to 24 weeks
Change in Depression From Before to After a 12-Week Intervention
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 12 weeks
Change in Depression From Pre-Intervention to 24-week Follow-up
Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 24 weeks
Adherence to During the Full 24-Week Study Period
Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24.
Time frame: 24 weeks
Participant Retention at 24 Week Follow-up
Percentage of participants retained at 24 weeks of those randomized
Time frame: 24 weeks
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol.
Time frame: Change from baseline to 12 weeks
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Time frame: Change from baseline to 24 weeks
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Time frame: Change from baseline to 12 weeks
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects.
Time frame: Change from baseline to 24 weeks
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better.
Time frame: Change from baseline to 12 weeks
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better.
Time frame: Change from baseline to 24 weeks
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better.
Time frame: Change from baseline to 12 weeks
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better.
Time frame: Change from baseline to 24 weeks
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 12 weeks
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better.
Time frame: Change from baseline to 24 weeks
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 12 weeks
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 24 weeks
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 12 weeks
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 24 weeks
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