Breast Cancer, Depression, Physical Activity
Conditions
Brief summary
Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.
Detailed description
The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6 month follow up. Intervention components will include print-based education, self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.
Interventions
BEHAVIORALPrint-based education
All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.
DEVICEFitbit
Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.
BEHAVIORALActive Living counseling
The Active Living counseling program consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.
OTHERFacility Access
Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Sponsors
American Cancer Society, Inc.
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Positive depression screen (PHQ-9) or current antidepressant treatment * Report \<150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ * Physically able to engage in physical activity * Written and verbal fluency in English
Exclusion criteria
* Medical condition contraindicating physical activity participation * Recurrence of breast cancer * Ductal carcinoma in situ (DCIS) diagnosis * Cognitively unable to give informed consent * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer | 6 months | Assess changes in physical activity at 6 months following physical activity intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) | 6 months | Assess changes in depressive symptoms at 6 months following physical activity intervention. Title: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity Intervention Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.
Print-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.
Fitbit: Subjects were provided a Fitbit and instructed to wear the device daily.
Active Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management.
Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.). | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Physical Activity Intervention |
|---|---|
| Age, Continuous | 55.19 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Moderate-to-Vigorous Physical Activity | 52.4 Minutes per week STANDARD_DEVIATION 19.5 |
| Quick Inventory of Depressive Symptomatology - Self-Rated | 13.63 units on a scale STANDARD_DEVIATION 4.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer
Assess changes in physical activity at 6 months following physical activity intervention.
Time frame: 6 months
Population: 12 participants provided valid baseline and follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity Intervention | Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer | 56.2 minutes per week | Standard Deviation 23.4 |
Secondary
Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)
Assess changes in depressive symptoms at 6 months following physical activity intervention. Title: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology
Time frame: 6 months
Population: 14 participants provided follow-up data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity Intervention | Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) | 9.7 units on a scale | Standard Deviation 4.5 |