Breast Cancer SurvivorsICANNCT04049695
Improving Cognition After Cancer
A study testing Exercise in people with Breast Cancer Survivors and Cognitive Dysfunction, run by University of California, San Diego at 1 site in United States.
Trial summary
This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer Survivors, Cognitive Dysfunction
- 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
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer
- self-report difficulties with cognition since their cancer diagnosis
- self-report low levels of moderate to vigorous physical activity
- have a Fitbit compatible device with internet
- breast cancer was treated with chemotherapy and/or hormonal therapy
Who cannot join
- medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
- currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months
- unable to commit to a 12-month study
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UCSD Cancer Center
La Jolla, California, 92093
About this study
Official title: A Randomized Trial of Physical Activity for Cognitive Functioning in Breast Cancer Survivors
This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
Read the detailed description
Many breast cancer survivors experience problems with mental abilities such as memory, attention, and concentration (known as cognition). Increasing physical activity has been shown to improve cognition in adults; however, little is known about whether this is helpful for cancer survivors as well. This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
- Conditions
- Breast Cancer Survivors, Cognitive Dysfunction
- 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
This intervention is based on Control Theory and Social Cognitive Theory and includes: 1) weekly emails with tips and tools to set personalized exercise goals and to increase exercise; 2) Health coaching phone sessions; 3) wrist worn monitor such as a Fitbit to track activity
ControlBehavioural
This intervention includes: 1) weekly emails with tips and tools to support health and wellness such as brain health, stress management, nutrition; 2) Health coaching phone sessions
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | This arm will receive a 12-month individually tailored phone and email-based exercise program. Receives: Behavioral: Exercise |
| Health & Wellness Intervention | Active comparator | This arm will receive a 12-month health and wellness 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 Digital Test
Measure of processing speed
Measured: Baseline to 6 months
Secondary outcomes (2)
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Measure of processing speed
Measured: Baseline to 12 months
Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities
Measure of Self-Report Cognition
Measured: Baseline to 6 months and Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start9 Sep 2019
- Primary completion19 Jan 2024
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 253 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
- NCT04049695
- Sponsor's protocol ID
- 182113
- Acronym
- ICAN
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2019
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartman SJ, Shao LY, Zablocki RW, Natarajan L, Ahles T, Palmer BW, Sears DD, Tam RM, Mac V, Dillon L, Yan C, Parker BA. Effectiveness of an exercise intervention on cognition in breast cancer survivors: a randomized controlled trial. J Natl Cancer Inst. 2026 Sep 30:djag295. doi: 10.1093/jnci/djag295. Online ahead of print.
PubMed 42810736Carlin D, Ott O, Sears DD, Ahles T, Desplats P, Hartman SJ. Exercise slows biological aging in breast cancer survivors: secondary analysis of a randomized trial. J Natl Cancer Inst. 2026 Sep 30:djag296. doi: 10.1093/jnci/djag296. Online ahead of print.
PubMed 42810733
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Physical Activity for Cognitive Functioning in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04049695
- Acronym / sponsor ID
- ICAN / 182113
- Conditions
- Breast Cancer Survivors, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
Detailed description
Many breast cancer survivors experience problems with mental abilities such as memory, attention, and concentration (known as cognition). Increasing physical activity has been shown to improve cognition in adults; however, little is known about whether this is helpful for cancer survivors as well. This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: ExerciseThis arm will receive a 12-month individually tailored phone and email-based exercise program. |
| Health & Wellness Intervention | Active comparator | Behavioral: ControlThis arm will receive a 12-month health and wellness program. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer
- self-report difficulties with cognition since their cancer diagnosis
- self-report low levels of moderate to vigorous physical activity
- have a Fitbit compatible device with internet
- breast cancer was treated with chemotherapy and/or hormonal therapy
Key exclusion criteria (3 listed)
- medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
- currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months
- unable to commit to a 12-month study
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 |
|---|---|---|
| ExerciseThis intervention is based on Control Theory and Social Cognitive Theory and includes: 1) weekly emails with tips and tools to set personalized exercise goals and to increase exercise; 2) Health coaching phone sessions; 3) wrist worn monitor such as a Fitbit to track activity | Behavioural | Exercise Intervention |
| ControlThis intervention includes: 1) weekly emails with tips and tools to support health and wellness such as brain health, stress management, nutrition; 2) Health coaching phone sessions | Behavioural | Health & Wellness Intervention |
Primary outcome
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Time frame: Baseline to 6 months
Measure of processing speed
2 secondary outcomes
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Time frame: Baseline to 12 months
Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities
Time frame: Baseline to 6 months and Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 42810736Hartman SJ, Shao LY, Zablocki RW, Natarajan L, Ahles T, Palmer BW, Sears DD, Tam RM, Mac V, Dillon L, Yan C, Parker BA. Effectiveness of an exercise intervention on cognition in breast cancer survivors: a randomized controlled trial. J Natl Cancer Inst. 2026 Sep 30:djag295. doi: 10.1093/jnci/djag295. Online ahead of print.
- Derived from this study: PubMed 42810733Carlin D, Ott O, Sears DD, Ahles T, Desplats P, Hartman SJ. Exercise slows biological aging in breast cancer survivors: secondary analysis of a randomized trial. J Natl Cancer Inst. 2026 Sep 30:djag296. doi: 10.1093/jnci/djag296. Online ahead of print.
- Individual participant dataSharing planned: No
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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 Breast Cancer Survivors and Cognitive Dysfunction, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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?
Results are not available in the source record.
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 Digital Test (time frame: Baseline to 6 months). 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 NCT04049695, which also lists 2 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 23 Aug 2024.