DepressionNCT02781051
Increasing Physical Activity Among Breast Cancer Survivors With Depression
A study testing Print-based education, Fitbit and Active Living counseling in people with Depression and Physical Activity, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Depression, Physical Activity, Breast Cancer
- What is being tested?
- Print-based education, Fitbit and Active Living counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.
Read the 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.
- Conditions
- Depression, Physical Activity, Breast Cancer
- Being tested
- Print-based education, Fitbit, Active Living counseling, Facility Access
- Medical subject headings
- Depression, Motor Activity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Print-based educationBehavioural
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.
FitbitDevice
Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.
Active Living counselingBehavioural
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.
Facility AccessOther
Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up. Receives: Behavioral: Print-based education; Device: Fitbit; Behavioral: Active Living counseling; Other: Facility Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer
Assess changes in physical activity at 6 months following physical activity intervention.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781051
- Sponsor's protocol ID
- STU 122015-072
- Status last verified
- Feb 2019
- First submitted
- 3 May 2016
- Last updated
- 22 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity Among Breast Cancer Survivors With Depression
- ClinicalTrials.gov ID
- NCT02781051
- Acronym / sponsor ID
- STU 122015-072
- Conditions
- Depression, Physical Activity, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- May 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Posted 22 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Behavioral: Print-based education, Device: Fitbit, Behavioral: Active Living counseling, Other: Facility AccessParticipants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Print-based educationAll 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. | Behavioural | Physical Activity Intervention |
| FitbitSubjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily. | Device | Physical Activity Intervention |
| Active Living counselingThe 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. | Behavioural | Physical Activity Intervention |
| Facility AccessSubjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.). | Other | Physical Activity Intervention |
Primary outcome
Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer
Time frame: 6 months
Assess changes in physical activity at 6 months following physical activity intervention.
1 secondary outcome
Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Print-based education, Fitbit and Active Living counseling in people with Depression and Physical Activity, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.