Breast Cancer Survivors, Cognitive Dysfunction
Conditions
Brief summary
Many cancer survivors experience treatment-related impairments in mental abilities such as memory, attention, and concentration (known as cognition). Research indicates that physical activity can improve cognition in healthy adults; however, little is known about whether physical activity can improve cognition among cancer survivors. This study will test whether a physical activity intervention results in improvements in cognition among breast cancer survivors, which may lead to interventions to improve cognition.
Interventions
BEHAVIORALExercise
BEHAVIORALControl
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* breast cancer survivors; diagnosed at stage 1, 2, or 3 less than 5 years ago - * not scheduled for or currently undergoing chemotherapy; sedentary, defined as engaging in less than 60 minutes of moderate to vigorous physical activity each week * accessible geographically and by telephone * have access to the internet * endorse experience difficulties with thinking abilities * in addition, participants on adjuvant therapy (e.g., tamoxifen or aromatase inhibitors) must be able and willing to remain on that treatment for the 3-month intervention period to prevent confounding of biomarker concentrations by treatment.
Exclusion criteria
* history of coronary heart disease, diabetes, stroke, orthopedic conditions that limit mobility, or any other serious medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention * other primary or recurrent invasive cancer within the last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ) * unable to commit to a 3-month intervention schedule; any condition that, in the investigators' judgment, would contraindicate increased physical activity or otherwise interfere with participation in the trial * unable to provide a blood sample at the baseline measurement visit * unable to speak and read English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test | Baseline to 12 weeks | Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Intervention This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program.
Exercise | 43 |
| Wellness Waitlist Control This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.
Control | 44 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Wellness Waitlist Control | Total | Exercise Intervention |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 9.3 | 57.2 years STANDARD_DEVIATION 10.36 | 58.2 years STANDARD_DEVIATION 11.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 72 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 71 Participants | 36 Participants |
| Sex: Female, Male Female | 44 Participants | 87 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 44 |
| serious Total, serious adverse events | 0 / 43 | 0 / 44 |
Outcome results
Primary
National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test
Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Intervention | National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test | 7 units on a scale | Standard Deviation 10.2 |
| Wellness Waitlist Control | National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test | 3 units on a scale | Standard Deviation 8.2 |
p-value: <0.05Mixed Models Analysis