Clinical Trial NU 15B02
- Impact of Chemotherapy on Activity Patterns in Breast Cancer Patients Undergoing Chemotherapy (IMPACT Study)
- Principal Investigator
- Siobhan Phillips
- Status: Accepting New Patients
- Study Type: Observation, QOL
- Protocol No:.NU 15B02
- This observational study is being conducted in order to better understand the changes in physical activity levels that women with breast cancer may experience while undergoing chemotherapy.
- Increased physical activity (PA) is consistently associated with fewer negative treatment related side effects, higher quality of life (QOL), longer survival, and reduced recurrence and mortality among cancer survivors. Studies suggest PA declines during treatment and does not return to pre-diagnosis levels. However, these data are largely based on infrequently assessed self-report measures. It is likely PA levels fluctuate from day to day over the course of treatment due to side effects and motivation. The goal of this research is to understand natural changes in activity patterns in women with breast cancer undergoing chemotherapy. The study aims to assess how activity patterns may change, what influences these changes, and how these changes influence health outcomes. Participants will be asked to partake in three “bursts” of data collection at the beginning, halfway through, and end of chemotherapy.
Some of the eligibility criteria include:
- Participants must be female and at least 18 years of age
- Participants must be diagnosed with stage 0-III breast cancer
- Participants must be scheduled to receive chemotherapy at Northwestern
- Participants must have no history of any other primary cancer with the exception of non-melanoma skin cancer
- Participants are required to own a smart phone and have access to a computer
- Patients are required to read and write in English
- Description of Treatment
- Participants will be asked to partake in three “bursts” of data collection at the beginning, approximately halfway through, and end of chemotherapy. Each measurement “burst” will last 10 days: three days prior to treatment, the day of chemotherapy treatment, and the 6 days following. During these 10 days, data collect will consist of wearing an activity monitor 24/7, answering 10-15 questions 4 times per day about motivation, symptoms and behaviors, as well as completing an online questionnaire battery. Assessments: Questionnaire Battery: Participants will be asked to complete 3 online questionnaires. These questionnaires will assess health history, health behaviors and symptoms and should take approximately 30 minutes each to complete. ActiGraph activity monitor: Participants will be asked to wear an ActiGraph activity monitor 24/7 for 10 days, except when bathing or swimming. This apparatus is similar to a pedometer. It is about the size of a pocket watch and is worn around the waist during the day and around the wrist during the night while sleeping. Participants should NOT change their behavior while wearing the activity monitor. We are interested in participants’ normal activity patterns. Daily Motivation, Symptoms and Behavior Questions: During each 10 day “burst”, participants will be prompted via text message 4 times per day to answer 10-15 questions regarding their motivation, symptoms and behaviors. These questions should take less than 3 minutes to answer. Participants who complete the on-line questionnaire battery, wear the Actigraph activity monitor, and answer the daily questions will be paid $100.00 following each “burst.” Therefore, participants will be paid a total of $300.00 for taking part in this research study. In addition to these procedures, this study includes an Optional Fitbit component. The purpose of wearing a Fitbit is to monitor physical activity every day during treatment. Participants will be asked to wear the study Fitbit 24/7, except when bathing, swimming or charging the device, starting within 24 hours of receiving the monitor until 2 weeks after their last treatment. Therefore, the study Fitbit would be worn in addition to the ActiGraph activity monitor during each of the three 10-day measurement "bursts". If participants agree to the optional Fitbit component, they will be able to keep the Fitbit at the end of the study in addition to the compensation provided above.
- Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
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last updated: 19-Oct-17 07:36 AM
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