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Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer

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ClinicalTrials.gov Identifier: NCT03045575
Recruitment Status : Unknown
Verified May 2018 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date January 27, 2017
First Posted Date February 7, 2017
Last Update Posted Date May 3, 2018
Actual Study Start Date August 2, 2016
Actual Primary Completion Date January 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2017)
Adherence [ Time Frame: 9 months ]
Adherence, defined at the percentage of weeks that a participant successfully synchs their Fitbit at least once a week during the course of the study, will be reported as a point estimate and 95% confidence interval
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 6, 2017)
  • Quality of Life - Physical Function [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS physical functioning questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Anxiety [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS anxiety questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Depression [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS depression questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Fatigue [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS fatigue questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Applied cognition general concerns [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS applied cognition general concerns questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Social roles [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS social roles questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Applied cognitive abilities [ Time Frame: 12 months from start of chemotherapy ]
    Mean of PROMIS applied cognitive abilities questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Sleep disturbance [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS sleep disturbance questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Sleep-related impairment [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS sleep-related impairment questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Pain interference [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of PROMIS pain interference questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Exercise Vital Sign [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Mean of the Exercise Vital Sign (A patient reported measure of the average minutes of moderate or greater physical activity they engage in per week) at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported.
  • Body Size [ Time Frame: Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy. ]
    Body mass index (BMI) will be calculated at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and at 6 months following chemotherapy.
Original Secondary Outcome Measures
 (submitted: February 3, 2017)
  • Quality of Life - Physical Function [ Time Frame: 12 months ]
    Mean of PROMIS physical functioning questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Anxiety [ Time Frame: 12 months ]
    Mean of PROMIS anxiety questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Depression [ Time Frame: 12 months ]
    Mean of PROMIS depression questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Fatigue [ Time Frame: 12 months ]
    Mean of PROMIS fatigue questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Applied cognition general concerns [ Time Frame: 12 months ]
    Mean of PROMIS applied cognition general concerns questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Social roles [ Time Frame: 12 months ]
    Mean of PROMIS social roles questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Applied cognitive abilities [ Time Frame: 12 months ]
    Mean of PROMIS applied cognitive abilities questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Sleep disturbance [ Time Frame: 12 months ]
    Mean of PROMIS sleep disturbance questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Sleep-related impairment [ Time Frame: 12 months ]
    Mean of PROMIS sleep-related impairment questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Pain interference [ Time Frame: 12 months ]
    Mean of PROMIS pain interference questionnaire scores at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported
  • Quality of Life - Exercise Vital Sign [ Time Frame: 12 months ]
    Mean of the Exercise Vital Sign (A patient reported measure of the average minutes of moderate or greater physical activity they engage in per week) at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and 6 months following chemotherapy will be reported.
  • Body Size [ Time Frame: 12 months ]
    Body mass index (BMI) will be calculated at baseline, midpoint of chemotherapy (This time-point is variable based on drug type, for example, if patient is on a 24 week regimen, midpoint would be distributed at week 12), end of chemotherapy, and at 6 months following chemotherapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer
Official Title Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer
Brief Summary This is a prospective observational study designed to determine the feasibility and acceptability of objectively measuring physical activity, sedentary time, and sleep using the Fitbit Charge HR wristband. 50 patients who have been diagnosed with breast cancer and are planning to initiate chemotherapy will be invited to participate in this study, and we will measure general and breast-specific quality-of-life using PROMIS measures for 3-6 months after completion of chemotherapy.
Detailed Description Over 3.1 million women are currently living with a diagnosis of breast cancer in the United States (US), representing 41% of all female cancer survivors in the US1. The increased breast cancer survival rate has necessitated a shift in cancer care toward developing interventions to empower patients to improve their quality-of-life, and perhaps prognosis, during and after treatment. Among women diagnosed with early-stage (I or II) breast cancer, around 40% will receive chemotherapy. Among women diagnosed with late-stage (III or IV), around 75% will receive chemotherapy.1 Adjuvant chemotherapy is associated with many side effects, including fatigue, nausea, disturbed sleep, decreased activity, and weight gain.2-5 Women receiving chemotherapy gain an average of 2.5 to 6.2 kg during therapy.6 Weight gain increases the risk of breast cancer recurrence and mortality, as well as cardiovascular disease, diabetes, and second primary cancers.7 Physical activity alleviates or reduces both short and long term treatment side effects of chemotherapy, including weight gain, and restores physical functioning in breast cancer patients.6,8,9Additionally, randomized controlled trials in breast cancer patients have shown that adding exercise to chemotherapy programs can improve breast cancer outcomes.10 Although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment.2 Existing research has relied on self-reported activity levels, which is a poor measure of low-intensity activities and can only capture a periodic snap shot of activity levels.2,11,12This study will provide objective physical activity data across the entirety of the patient's chemotherapy treatments. This in depth data will provide a new perspective on the patterns of activity levels and help to identify if there are critical times in which to intervene to prevent physical activity declines.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Potentially eligible patients who are planning to initiate chemotherapy for breast cancer will be identified through the Breast Care Clinic. Our power calculation is based on the proportion of patients who successfully complete the study, defined as ≥70% of participants wearing the Fitbit and completing the post-chemotherapy follow-up assessment. Using a 1-sided 1-sample binomial test with α = 0.05, 50 patients, an expected successful completion proportion of 70%, we will have 80% power to reject the null hypothesis if 53% or fewer participants successfully complete the protocol. In other words, the intervention will be considered feasible if 27 or more participants in complete the protocol.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: May 1, 2018)
65
Original Estimated Enrollment
 (submitted: February 3, 2017)
60
Estimated Study Completion Date December 31, 2018
Actual Primary Completion Date January 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • have been diagnosed with breast cancer
  • be planning to initiate chemotherapy for breast cancer at UCSF
  • be able to speak and read English, or have a family member or friend who can assist in translating and completing surveys in English
  • be able to walk unassisted
  • be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet

Exclusion Criteria:

  • We will exclude individuals who cannot speak or read English unless they have a friend or family member who can assist in translating and completing quality of life surveys in English. In addition, the Fitbit® requires the ability to connect to the Internet and input data in a website, therefore we will exclude patients with no regular access to the Internet or who are unable to fill out forms on the web or navigate websites. We will exclude patients who are unable to walk unassisted.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03045575
Other Study ID Numbers 15-17054
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Michelle Melisko, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2018