Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2018
Start Date:August 2, 2016
End Date:December 31, 2018

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
1
site
San Francisco, California 94115
Phone: 415-353-7070
?
mi
from
San Francisco, CA
Click here to add this to my saved trials