Breast CancerPhase 2NCT01540955
Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors
A Phase 2 study testing Improving Cognition with group intervention in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
There are over 2 million breast cancer survivors in the US today. Along with extended survival, many women experience short and long-term after effects of treatment, which may decrease their quality of life and contribute to other health problems. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Improving Cognition with group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2013
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21-65 years
- stage I, II, III breast cancer diagnosis within the past 18 months to 5 years
- currently disease free, but may be on endocrine therapy
- with evidence of need of cognitive therapeutic intervention, as demonstrated by mild or greater cognitive deficiencies on an objective screening measure
- reads and writes English
- able to give informed consent
- willing and able to attend 5 weekly group sessions and participate in pre and post-evaluation that will take place on the UCLA campus
Who cannot join
- evidence of uncontrolled depression
Trial locations and contacts
1 site in 1 country.
About this study
There are over 2 million breast cancer survivors in the US today. Along with extended survival, many women experience short and long-term after effects of treatment, which may decrease their quality of life and contribute to other health problems. Cognitive complaints---difficulties with memory, concentration, and planning-are commonly reported after adjuvant treatments for breast cancer. This study is designed to test the efficacy of a 5 week group-based cognitive rehabilitation intervention on improving cognitive complaints and test performance, in comparison to women who will receive the same intervention at a later time (wait-list control). Women will also have an EEG test performed before and after the intervention program to see if improvements in cognitive complaints and performance can be documented by examining the EEG.
Read the detailed description
Previous pilot work (non-randomized, pre-post design) has shown that this intervention was effective in improving post-intervention cognitive complaints and neuropsychological (NP) test performance. Because practice effects may influence NP performance, it is important to compare the intervention participants to women who are not exposed to the intervention. Thus, this randomized controlled trial will compare the active intervention to a control group of patients who will receive the intervention at a delayed time point. The primary outcomes are improvements in cognitive complaints and NP test performance 2 months after completion of the intervention program. Quantitative EEG (QEEG) measurements will be used as a secondary exploratory endpoint to see if this may be an effective biomarker of cognitive performance.
- Conditions
- Breast Cancer
- Being tested
- Improving Cognition with group intervention
- Keywords
- Reduce Cognitive Complaints, improve cognitive function, post-treatment breast cancer patients
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving Cognition with group interventionBehavioural
Participants attend 5 weekly group sessions that are 2 hours each, delivered by a trained therapist. Sessions focus on specific aspects of attention, memory, multi-tasking and encoding. Homework assignments are practiced between classes. Goals are set for improved functioning.
| Study group | Role | What they receive |
|---|---|---|
| Group Intervention program | Experimental | Not described Receives: Behavioral: Improving Cognition with group intervention |
| Wait-list control group | No intervention | The wait-list-control group will also be able to participate in the group intervention, but not until after all the study visits have been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function measured by neuropsychological assessment 2 months after group intervention
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionSep 2013
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 Jonsson Comprehensive Cancer 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Patricia Ganz, M.D., Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540955
- Sponsor's protocol ID
- 11-003446
- Other IDs
- JCCCID256
- Status last verified
- Apr 2015
- First submitted
- 16 Feb 2012
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01540955
- Acronym / sponsor ID
- 11-003446
- Conditions
- Breast Cancer
- Keywords
- Reduce Cognitive Complaints, improve cognitive function, post-treatment breast cancer patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Feb 2012 (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.
There are over 2 million breast cancer survivors in the US today. Along with extended survival, many women experience short and long-term after effects of treatment, which may decrease their quality of life and contribute to other health problems. Cognitive complaints---difficulties with memory, concentration, and planning-are commonly reported after adjuvant treatments for breast cancer. This study is designed to test the efficacy of a 5 week group-based cognitive rehabilitation intervention on improving cognitive complaints and test performance, in comparison to women who will receive the same intervention at a later time (wait-list control). Women will also have an EEG test performed before and after the intervention program to see if improvements in cognitive complaints and performance can be documented by examining the EEG.
Detailed description
Previous pilot work (non-randomized, pre-post design) has shown that this intervention was effective in improving post-intervention cognitive complaints and neuropsychological (NP) test performance. Because practice effects may influence NP performance, it is important to compare the intervention participants to women who are not exposed to the intervention. Thus, this randomized controlled trial will compare the active intervention to a control group of patients who will receive the intervention at a delayed time point. The primary outcomes are improvements in cognitive complaints and NP test performance 2 months after completion of the intervention program. Quantitative EEG (QEEG) measurements will be used as a secondary exploratory endpoint to see if this may be an effective biomarker of cognitive performance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Intervention program | Experimental | Behavioral: Improving Cognition with group intervention |
| Wait-list control group | No intervention | –The wait-list-control group will also be able to participate in the group intervention, but not until after all the study visits have been completed. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 21-65 years
- stage I, II, III breast cancer diagnosis within the past 18 months to 5 years
- currently disease free, but may be on endocrine therapy
- with evidence of need of cognitive therapeutic intervention, as demonstrated by mild or greater cognitive deficiencies on an objective screening measure
- reads and writes English
Key exclusion criteria (1 listed)
- evidence of uncontrolled depression
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 |
|---|---|---|
| Improving Cognition with group interventionParticipants attend 5 weekly group sessions that are 2 hours each, delivered by a trained therapist. Sessions focus on specific aspects of attention, memory, multi-tasking and encoding. Homework assignments are practiced between classes. Goals are set for improved functioning. | Behavioural | Group Intervention program |
Primary outcome
Cognitive function measured by neuropsychological assessment 2 months after group intervention
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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.
Patricia Ganz, M.D. principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Improving Cognition with group intervention in people with Breast Cancer, run by Jonsson Comprehensive Cancer 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 7 inclusion and 1 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 10 Apr 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive function measured by neuropsychological assessment 2 months after group intervention (time frame: 2 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 10 Apr 2015.