Breast CancerNCT02166983
Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors
A study testing computer-assisted cognitive training, cognitive intervention and mind-body intervention procedure in people with Breast Cancer and Cancer Survivor, run by Stanford University at 1 site in United States.
Trial summary
This randomized clinical trial studies cognitive enhancement program in improving cognitive function in breast cancer survivors. A cognitive enhancement program may help improve cognitive function in breast cancer survivors and may help doctors plan better treatment for cognitive decline. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer Survivor, Cognitive/Functional Effects
- What is being tested?
- computer-assisted cognitive training, cognitive intervention and mind-body intervention procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2016
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of breast cancer
- Received chemotherapy treatment for breast cancer diagnosis
- Chemotherapy-free for at least one year
Who cannot join
- History of learning disability, head trauma, neurologic disorder or significant psychiatric condition
- Significant medical condition (e.g. diabetes) unrelated to cancer diagnosis
- Magnetic resonance imaging (MRI) contraindications (e.g. metallic biomedical implants)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: Cognitive Enhancement Program
This randomized clinical trial studies cognitive enhancement program in improving cognitive function in breast cancer survivors. A cognitive enhancement program may help improve cognitive function in breast cancer survivors and may help doctors plan better treatment for cognitive decline.
Read the detailed description
PRIMARY OBJECTIVES:
- To improve cognition of women who have had breast cancer and exhibit cognitive decline through a cognitive enhancement program.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (Cognitive Enhancement Program): Participants are randomized to 1 of 2 arms.
ARM IA (Lumosity): Participants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible.
ARM IB (Active Journaling): Participants complete Active Journal cognitive exercises. Active Journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. Active Journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises and compensatory strategies as in Arm IA.
ARM II (Lumosity only): Participants complete Lumosity cognitive exercises as in Arm IA.
- Conditions
- Breast Cancer, Cancer Survivor, Cognitive/Functional Effects
- Being tested
- computer-assisted cognitive training, cognitive intervention, mind-body intervention procedure, memory intervention, questionnaire administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted cognitive trainingOther
Complete Lumosity cognitive exercises
cognitive interventionOther
Complete Active Journaling cognitive exercises
mind-body intervention procedureProcedure or surgery
Also called mind-body interventions
Complete relaxation exercises
memory interventionOther
Complete compensatory strategies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm IA (Lumosity, relaxation, compensatory strategies) | Experimental | Participants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible. Receives: Other: computer-assisted cognitive training; Procedure: mind-body intervention procedure; Other: memory intervention; Other: questionnaire administration |
| Arm IB (Active Journaling, relaxation, compensatory strategy) | Experimental | Participants complete Active Journal cognitive exercises. Active Journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. Active Journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises and compensatory strategies as in Arm IA. Receives: Other: cognitive intervention; Procedure: mind-body intervention procedure; Other: memory intervention; Other: questionnaire administration |
| Arm II (Lumosity only) | Experimental | Participants complete Lumosity exercises as in Arm IA. Receives: Other: computer-assisted cognitive training; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Executive Function Test Composite Score
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
Why it stopped: PI left Stanford
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shelli Kesler, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166983
- Sponsor's protocol ID
- BRS0037
- Other IDs
- NCI-2013-02353, BRS0037, P30CA124435
- Status last verified
- Nov 2014
- First submitted
- 16 Dec 2013
- Last updated
- 24 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Enhancement Program
- ClinicalTrials.gov ID
- NCT02166983
- Acronym / sponsor ID
- BRS0037
- Conditions
- Breast Cancer, Cancer Survivor, Cognitive/Functional Effects
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left Stanford
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- 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 randomized clinical trial studies cognitive enhancement program in improving cognitive function in breast cancer survivors. A cognitive enhancement program may help improve cognitive function in breast cancer survivors and may help doctors plan better treatment for cognitive decline.
Detailed description
PRIMARY OBJECTIVES:
- To improve cognition of women who have had breast cancer and exhibit cognitive decline through a cognitive enhancement program.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (Cognitive Enhancement Program): Participants are randomized to 1 of 2 arms.
ARM IA (Lumosity): Participants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible.
ARM IB (Active Journaling): Participants complete Active Journal cognitive exercises. Active Journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. Active Journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises and compensatory strategies as in Arm IA.
ARM II (Lumosity only): Participants complete Lumosity cognitive exercises as in Arm IA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm IA (Lumosity, relaxation, compensatory strategies) | Experimental | Other: computer-assisted cognitive training, Procedure: mind-body intervention procedure, Other: memory intervention, Other: questionnaire administrationParticipants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible. |
| Arm IB (Active Journaling, relaxation, compensatory strategy) | Experimental | Other: cognitive intervention, Procedure: mind-body intervention procedure, Other: memory intervention, Other: questionnaire administrationParticipants complete Active Journal cognitive exercises. Active Journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. Active Journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises and compensatory strategies as in Arm IA. |
| Arm II (Lumosity only) | Experimental | Other: computer-assisted cognitive training, Other: questionnaire administrationParticipants complete Lumosity exercises as in Arm IA. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previous diagnosis of breast cancer
- Received chemotherapy treatment for breast cancer diagnosis
- Chemotherapy-free for at least one year
Key exclusion criteria (4 listed)
- History of learning disability, head trauma, neurologic disorder or significant psychiatric condition
- Significant medical condition (e.g. diabetes) unrelated to cancer diagnosis
- Magnetic resonance imaging (MRI) contraindications (e.g. metallic biomedical implants)
- Pregnancy
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 |
|---|---|---|
| computer-assisted cognitive trainingComplete Lumosity cognitive exercises | Other | Arm IA (Lumosity, relaxation, compensatory strategies), Arm II (Lumosity only) |
| cognitive interventionComplete Active Journaling cognitive exercises | Other | Arm IB (Active Journaling, relaxation, compensatory strategy) |
| mind-body intervention procedureAlso: mind-body interventionsComplete relaxation exercises | Procedure or surgery | Arm IA (Lumosity, relaxation, compensatory strategies), Arm IB (Active Journaling, relaxation, compensatory strategy) |
| memory interventionComplete compensatory strategies | Other | Arm IA (Lumosity, relaxation, compensatory strategies), Arm IB (Active Journaling, relaxation, compensatory strategy) |
| questionnaire administrationAncillary studies | Other | Arm IA (Lumosity, relaxation, compensatory strategies), Arm IB (Active Journaling, relaxation, compensatory strategy), Arm II (Lumosity only) |
Primary outcome
Standardized Executive Function Test Composite Score
Time frame: Baseline to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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.
Shelli Kesler principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-assisted cognitive training, cognitive intervention and mind-body intervention procedure in people with Breast Cancer and Cancer Survivor, run by Stanford University 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 24 Nov 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Standardized Executive Function Test Composite Score (time frame: Baseline to 3 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 24 Nov 2014.