Cognitive DysfunctionNCT02332876
Physical Activity and Neuropsychological Outcomes in a Cancer Population
A study testing Exercise in people with Cognitive Dysfunction and Breast Cancer Survivors, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 85 years, women only
- Conditions the study is for
- Cognitive Dysfunction, Breast Cancer Survivors
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2016
- 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 21 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UCSD Cancer Center
La Jolla, California, 92093
About this study
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.
- Conditions
- Cognitive Dysfunction, Breast Cancer Survivors
- Being tested
- Exercise, Control
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | This arm will receive a 12-week individually tailored phone and email-based exercise program. Receives: Behavioral: Exercise |
| Wellness Waitlist Control | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionJul 2016
- Study completionJul 2016
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheri Hartman, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332876
- Sponsor's protocol ID
- 1K07CA181323-01A1
- Status last verified
- Jul 2018
- First submitted
- 23 Dec 2014
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hartman SJ, Chen R, Tam RM, Narayan HK, Natarajan L, Liu L. Fitbit Use and Activity Levels From Intervention to 2 Years After: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jun 30;10(6):e37086. doi: 10.2196/37086.
PubMed 35771607Hartman SJ, Weiner LS, Nelson SH, Natarajan L, Patterson RE, Palmer BW, Parker BA, Sears DD. Mediators of a Physical Activity Intervention on Cognition in Breast Cancer Survivors: Evidence From a Randomized Controlled Trial. JMIR Cancer. 2019 Oct 11;5(2):e13150. doi: 10.2196/13150.
PubMed 31605514Weiner LS, Takemoto M, Godbole S, Nelson SH, Natarajan L, Sears DD, Hartman SJ. Breast cancer survivors reduce accelerometer-measured sedentary time in an exercise intervention. J Cancer Surviv. 2019 Jun;13(3):468-476. doi: 10.1007/s11764-019-00768-8. Epub 2019 May 29.
PubMed 31144265Hartman SJ, Nelson SH, Weiner LS. Patterns of Fitbit Use and Activity Levels Throughout a Physical Activity Intervention: Exploratory Analysis from a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Feb 5;6(2):e29. doi: 10.2196/mhealth.8503.
PubMed 29402761
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Neuropsychological Outcomes in a Cancer Population
- ClinicalTrials.gov ID
- NCT02332876
- Acronym / sponsor ID
- 1K07CA181323-01A1
- Conditions
- Cognitive Dysfunction, Breast Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Posted 11 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: ExerciseThis arm will receive a 12-week individually tailored phone and email-based exercise program. |
| Wellness Waitlist Control | Active comparator | Behavioral: ControlThis 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Exercise | Behavioural | Exercise Intervention |
| Control | Behavioural | Wellness Waitlist Control |
Primary outcome
National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35771607Hartman SJ, Chen R, Tam RM, Narayan HK, Natarajan L, Liu L. Fitbit Use and Activity Levels From Intervention to 2 Years After: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jun 30;10(6):e37086. doi: 10.2196/37086.
- Derived from this study: PubMed 31605514Hartman SJ, Weiner LS, Nelson SH, Natarajan L, Patterson RE, Palmer BW, Parker BA, Sears DD. Mediators of a Physical Activity Intervention on Cognition in Breast Cancer Survivors: Evidence From a Randomized Controlled Trial. JMIR Cancer. 2019 Oct 11;5(2):e13150. doi: 10.2196/13150.
- Derived from this study: PubMed 31144265Weiner LS, Takemoto M, Godbole S, Nelson SH, Natarajan L, Sears DD, Hartman SJ. Breast cancer survivors reduce accelerometer-measured sedentary time in an exercise intervention. J Cancer Surviv. 2019 Jun;13(3):468-476. doi: 10.1007/s11764-019-00768-8. Epub 2019 May 29.
- Derived from this study: PubMed 29402761Hartman SJ, Nelson SH, Weiner LS. Patterns of Fitbit Use and Activity Levels Throughout a Physical Activity Intervention: Exploratory Analysis from a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Feb 5;6(2):e29. doi: 10.2196/mhealth.8503.
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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 Exercise in people with Cognitive Dysfunction and Breast Cancer Survivors, run by University of California, San Diego 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 6 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 11 Jul 2018. 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 11 Jul 2018). 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?
National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332876, which also lists 4 linked publications.
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 11 Jul 2018.