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OpenTrials
Completed

NCT Number: NCT03131440

Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

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.

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Key information

Conditions

Breast Cancer Female Behavior Motor Activity Physical Activity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Stage I-III breast cancer within the last 5 years
  • Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
  • English speaking
  • Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
  • Own a smartphone
  • Have access to a computer with Internet
  • Participants may be using adjuvant endocrine therapies.
  • Willing to be waitlisted for future wave if current wave reaches capacity

Exclusion criteria

-Women will be excluded if they report any of the following:

  • Respiratory, joint or cardiovascular problems precluding physical activity
  • Metastatic disease
  • Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).

ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:

  • A prior cardiovascular event (i.e. stroke, myocardial infarction)
  • Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)

Treatment and study plan

Core

Behavioral

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

Support Calls

Behavioral

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

App+

Behavioral

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

Online gym

Behavioral

Participants will receive access to online exercise videos.

App notifications

Behavioral

Participants will receive motivational app notifications

Buddy

Behavioral

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

Primary outcomes

  1. Adherence to a 12 Week Technology Supported Physical Activity Intervention

    Time frame: 12 weeks

    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.

  2. Participant Retention

    Time frame: 12 weeks

    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].

  3. Intervention Reach

    Time frame: Baseline

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

Secondary outcomes

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

    Time frame: Change from baseline to 12 weeks

    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).

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

    Time frame: Change from baseline to 24 weeks

    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).

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

    Time frame: Change from baseline to 12 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 12 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 12 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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.

  9. Adherence to During the Full 24-Week Study Period

    Time frame: 24 weeks

    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.

  10. Participant Retention at 24 Week Follow-up

    Time frame: 24 weeks

    Percentage of participants retained at 24 weeks of those randomized

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

    Time frame: Change from baseline to 12 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 12 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 12 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 12 weeks

    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.

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 12 weeks

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

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

    Time frame: Change from baseline to 24 weeks

    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.

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

    Time frame: Change from baseline to 12 weeks

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

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

    Time frame: Change from baseline to 24 weeks

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

  23. Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)

    Time frame: Change from baseline to 12 weeks

    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.

  24. Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)

    Time frame: Change from baseline to 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2017
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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