Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03045575
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2017-01-27
Brief Title:
Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Over 31 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 25 to 62 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-17054 | OTHER | University of California San Francisco | None |