Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

core, support calls, app+, app notifications

core, support calls, buddy, app notifications

core, support calls, online gym, app notifications

core, app+, buddy, online gym, app notifications

core, support calls, buddy, online gym, app notifications

core, buddy, online gym, app notifications

core, app+, online gym, app notifications

core, support calls, app+, buddy, online gym

core, support calls, app+, buddy, app notifications

core, support calls, app+, online gym, app notifications

core, support calls, app+, buddy, online gym, app notifications

The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Core

Participants will receive 6 bi-weekly phone calls from study staff.

Support Calls

Participants will receive "deluxe" version of smartphone app with additional features.

App+

Participants will receive access to online exercise videos.

Online gym

Participants will receive motivational app notifications

App notifications

Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Buddy

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.

Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors

Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.

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.

Percentage of participants retained at the end of the 12 week intervention of those randomized \[(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized\*100\].

Percentage of individuals randomized of those who were sent a study screening survey

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).

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).

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.

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.

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.

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.

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.

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.

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.

Percentage of participants retained at 24 weeks of those randomized

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.

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.

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.

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.

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.

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.

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.

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.

Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.

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.

Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.

Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.

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.

National Cancer Institute (NCI)

Northwestern University

Assistant Professor

core, support calls

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

Experimental Condition #1

core, support calls, app+

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Experimental Condition #2

core, support calls, buddy

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #3

core, support calls, online gym

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

Online gym: Participants will receive access to online exercise videos.

Experimental Condition #4

core, support calls, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App notifications: Participants will receive motivational app notifications

Experimental Condition #5

core, app+

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Experimental Condition #6

core, app+, buddy

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #7

core, app+, online gym

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Online gym: Participants will receive access to online exercise videos.

Experimental Condition #8

core, app+, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

App notifications: Participants will receive motivational app notifications

Experimental Condition #9

core, buddy

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #10

core, buddy, online gym

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Online gym: Participants will receive access to online exercise videos.

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #11

core, buddy, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App notifications: Participants will receive motivational app notifications

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #12

core, online gym

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Online gym: Participants will receive access to online exercise videos.

Experimental Condition #13

core, online gym, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Online gym: Participants will receive access to online exercise videos.

App notifications: Participants will receive motivational app notifications

Experimental Condition #14

core, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App notifications: Participants will receive motivational app notifications

Experimental Condition #15

core, support calls, app+, buddy

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #16

core, support calls, app+, online gym

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Online gym: Participants will receive access to online exercise videos.

Experimental Condition #17

core, support calls, app+, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

App notifications: Participants will receive motivational app notifications

Experimental Condition #18

core, support calls, buddy, online gym

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

Online gym: Participants will receive access to online exercise videos.

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #19

core, support calls, buddy, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App notifications: Participants will receive motivational app notifications

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #20

core, support calls, online gym, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

Online gym: Participants will receive access to online exercise videos.

App notifications: Participants will receive motivational app notifications

Experimental Condition #21

core, app+, buddy, online gym

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Online gym: Participants will receive access to online exercise videos.

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #22

core, app+, buddy, online gym, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Online gym: Participants will receive access to online exercise videos.

App notifications: Participants will receive motivational app notifications

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #23

core, support calls, buddy, online gym, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

Online gym: Participants will receive access to online exercise videos.

App notifications: Participants will receive motivational app notifications

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #24

core, buddy, online gym, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Online gym: Participants will receive access to online exercise videos.

App notifications: Participants will receive motivational app notifications

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #25

core, app+, online gym, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Online gym: Participants will receive access to online exercise videos.

App notifications: Participants will receive motivational app notifications

Experimental Condition #26

core, support calls, app+, buddy, online gym

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Online gym: Participants will receive access to online exercise videos.

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #27

core, support calls, app+, buddy, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

App notifications: Participants will receive motivational app notifications

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #28

core, support calls, app+, online gym, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Online gym: Participants will receive access to online exercise videos.

App notifications: Participants will receive motivational app notifications

Experimental Condition #29

core

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Experimental Condition #30

core, app+, buddy, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

App notifications: Participants will receive motivational app notifications

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #31

core, support calls, app+, buddy, online gym, app notifications

Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.

App+: Participants will receive "deluxe" version of smartphone app with additional features.

Online gym: Participants will receive access to online exercise videos.

App notifications: Participants will receive motivational app notifications

Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Experimental Condition #32

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Number of Participants Randomized

Siobhan Phillips

All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.

All Reporting Groups

Adherence to a 12 Week Technology Supported Physical Activity Intervention

Participant Retention

Intervention Reach

"On" Group Change

"Off" Group Change

Participants receive 6 bi-weekly phone calls from study staff.

Participants choose a buddy to receive a Fitbit and support them during the intervention

Participants receive motivational app notifications

App Notifications

Participants receive access to online exercise videos.

Online Gym

Participants receive "deluxe" version of smartphone app with additional features.

Participants receive educational materials, access to a basic smartphone app and a Fitbit.

Core Intervention

One participant was excluded because data values were deemed implausible. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention

Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up

All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in Fatigue From Before to After a 12-Week Intervention

Change in Fatigue From Pre-Intervention to 24-Week Follow-up

Change in Physical Function From Before to After a 12-Week Intervention

Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up

Change in Depression From Before to After a 12-Week Intervention

Change in Depression From Pre-Intervention to 24-week Follow-up

Adherence to During the Full 24-Week Study Period

Participant Retention at 24 Week Follow-up

Participants choose a buddy to receive a Fitbit and support them during the intervention.

This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-6. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)

This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-6.In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)

This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-10. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)

Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)

This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for TNFα. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)

Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)

This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for CRP. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)

Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)

This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for triglycerides. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in Triglycerides From Before to After a 12 Week Intervention (Optional)

Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)

This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for blood glucose. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)

Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)

This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for HDL. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors	NCT03131440	Breast Cancer F... Physical Activi...	Core Support Calls App+ Online gym App notificatio... Buddy	18 Years -	Northwestern University
Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors	NCT03131440	Breast Cancer F... Physical Activi...	Core Support Calls App+ Online gym App notificatio... Buddy	18 Years -	Northwestern University

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