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Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045575
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 Patient-Reported Outcomes Measurement Information System (PROMIS) measures for 3-6 months after completion of chemotherapy.

Condition or disease
Breast Cancer

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 US. 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. Adjuvant chemotherapy is associated with many side effects, including fatigue, nausea, disturbed sleep, decreased activity, and weight gain. Women receiving chemotherapy gain an average of 2.5 to 6.2 kg during therapy. Weight gain increases the risk of breast cancer recurrence and mortality, as well as cardiovascular disease, diabetes, and second primary cancers. 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. Additionally, randomized controlled trials in breast cancer patients have shown that adding exercise to chemotherapy programs can improve breast cancer outcomes.

Although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment. 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. This 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.

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer
Actual Study Start Date : August 2, 2016
Actual Primary Completion Date : January 18, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Adherence [ Time Frame: 9 months ]
    Adherence, defined at the percentage of weeks that a participant successfully syncs their Fitbit at least once a week during the course of the study, will be reported as a point estimate and 95% confidence interval


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • have been diagnosed with breast cancer
  • be planning to initiate chemotherapy for breast cancer at University of California, San Francisco (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045575


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Michelle Melisko, MD University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03045575    
Other Study ID Numbers: 157512
15-17054 ( Other Identifier: University of California, San Francisco )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases