Cancer SurvivorNCT02662335
Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors
A study testing Computer-Assisted Cognitive Training, Questionnaire Administration and Standard Follow-Up Care in people with Cancer Survivor and Stage 0 Breast Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies computerized cognitive retraining in improving cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as thinking and memory issues, are common among breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer
- What is being tested?
- Computer-Assisted Cognitive Training, Questionnaire Administration and Standard Follow-Up Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 30 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer (stage 0, I, II, III), 18 months to 5 years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors)
- Able to read, write, and speak English
- Mini Mental State Exam score greater than or equal to 19
- Have reliable internet and daily access to computer with audio/speakers
- Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for 2-3 in person assessments over the 12-13 weeks of the study
Who cannot join
- History of multiple cancers
- History of central nervous system (CNS) disease, CNS radiation, intrathecal therapy, or CNS surgery
- History of traumatic brain injury
- Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer's disease, Parkinson's disease
- Self-report of learning disabilities
- Substance addiction
Show all 14Show fewer
- Diagnosis of psychiatric disorders of psychosis, schizophrenia, or bipolar disorder
- Mini mental state exam score less than 19
- Previous participation in cognitive training program
- Visual impairments such as uncorrected vision or color blindness
- Uncorrected hearing impairments
- Self-report that they are not pregnant or planning to become pregnant in the next four months
- Anticipate moving from the region in the next 4 months
- Inability to use a mouse or computer keys to navigate around the computer screen
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Computerized Cognitive Retraining in Breast Cancer Survivors
This randomized clinical trial studies computerized cognitive retraining in improving cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as thinking and memory issues, are common among breast cancer survivors. The severity of these cognitive deficits is associated with a significant negative impact on daily function and quality of life. A computerized cognitive retraining method may help researchers find ways to improve cognitive function and quality of life in breast cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the feasibility and acceptability of a 6-week computerized working memory training program in breast cancer survivors who subjectively report cognitive deficits: evaluate feasibility of study procedures (recruitment and screening procedures, number of participants recruited, screened, and retained, attrition rate and reason, weekly phone calls completed with participants); evaluate the acceptability of an adaptive computerized working memory training intervention (burden, adherence to training schedule, performance level achieved, and participant satisfaction with computerized exercises).
SECONDARY OBJECTIVES:
- To evaluate the difference in the posttest means at T2 (week #7) adjusted for T1 (baselines) in the primary working memory outcomes of visuo-spatial working memory (VSWM), visual working memory (VWM), and executive function (EF) as measured by the neuropsychological tests (Rey Auditory Test, Wechsler Adult Intelligence Scale [WAIS] IV symbol test, WAIS IV coding test, Delis-Kaplan Executive Function System [DKFES] color tests, Trails A and Trails B tests, and WAIS IV Letter and Number sequencing test) and self-report Patient Reported Outcomes Measurement Information System (PROMIS) surveys (Applied Cognition General Concerns Short Form, Applied Cognition Executive Function Short Form, and Functional Assessment of Cancer Therapy [FACT] Cognitive Function) between the intervention group and wait control group.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (COMPUTER-ASSISTED COGNITIVE TRAINING): Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.
ARM II (WAIT LIST): Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.
- Conditions
- Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Being tested
- Computer-Assisted Cognitive Training, Questionnaire Administration, Standard Follow-Up Care
- Medical subject headings
- Breast Carcinoma In Situ, 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
Participate in Cogmed computerized working memory training
Questionnaire AdministrationOther
Ancillary studies
Standard Follow-Up CareProcedure or surgery
Undergo standard follow-up care
| Study group | Role | What they receive |
|---|---|---|
| Arm I (computer-assisted cognitive training) | Experimental | Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks. Receives: Other: Computer-Assisted Cognitive Training; Other: Questionnaire Administration |
| Arm II (wait-list) | Active comparator | Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13. Receives: Other: Questionnaire Administration; Procedure: Standard Follow-Up Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition rate
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Measured: Up to 7 weeks
Percentage of participants retained in the study
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Measured: Up to 7 weeks
Percentage of participants who are recruited
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Measured: Up to 7 weeks
Satisfaction, measured by the satisfaction survey
Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey.
Measured: Up to 7 weeks
Secondary outcomes (7)
Anxiety
PROMIS Emotional Distress-Anxiety-Short Form.
Measured: Baseline to up to 7 weeks
Cognition
FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form.
Measured: Baseline to up to 7 weeks
Depression
PROMIS Emotional Distress -Depression Short Form.
Measured: Baseline to up to 7 weeks
Executive Function
D-KEFS color word tests, Trails A and B, and Letter-number sequencing.
Measured: Baseline to up to 7 weeks
Fatigue
PROMIS Fatigue-Short Form.
Measured: Baseline to up to 7 weeks
Verbal Working Memory
REY auditory verbal word memory recall and recognition test.
Measured: Baseline to up to 7 weeks
Visuo Spatial Working Memory
Symbol recognition and coding test.
Measured: Baseline to up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startMay 2016
- Primary completion13 Dec 2016
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathleen Shannon Dorcy, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662335
- Sponsor's protocol ID
- 9363
- Other IDs
- NCI-2015-02193, 9363, P30CA015704
- Status last verified
- Dec 2017
- First submitted
- 20 Jan 2016
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Retraining in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02662335
- Acronym / sponsor ID
- 9363
- Conditions
- Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2016
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 25 Jan 2016 (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 computerized cognitive retraining in improving cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as thinking and memory issues, are common among breast cancer survivors. The severity of these cognitive deficits is associated with a significant negative impact on daily function and quality of life. A computerized cognitive retraining method may help researchers find ways to improve cognitive function and quality of life in breast cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the feasibility and acceptability of a 6-week computerized working memory training program in breast cancer survivors who subjectively report cognitive deficits: evaluate feasibility of study procedures (recruitment and screening procedures, number of participants recruited, screened, and retained, attrition rate and reason, weekly phone calls completed with participants); evaluate the acceptability of an adaptive computerized working memory training intervention (burden, adherence to training schedule, performance level achieved, and participant satisfaction with computerized exercises).
SECONDARY OBJECTIVES:
- To evaluate the difference in the posttest means at T2 (week #7) adjusted for T1 (baselines) in the primary working memory outcomes of visuo-spatial working memory (VSWM), visual working memory (VWM), and executive function (EF) as measured by the neuropsychological tests (Rey Auditory Test, Wechsler Adult Intelligence Scale [WAIS] IV symbol test, WAIS IV coding test, Delis-Kaplan Executive Function System [DKFES] color tests, Trails A and Trails B tests, and WAIS IV Letter and Number sequencing test) and self-report Patient Reported Outcomes Measurement Information System (PROMIS) surveys (Applied Cognition General Concerns Short Form, Applied Cognition Executive Function Short Form, and Functional Assessment of Cancer Therapy [FACT] Cognitive Function) between the intervention group and wait control group.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (COMPUTER-ASSISTED COGNITIVE TRAINING): Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.
ARM II (WAIT LIST): Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (computer-assisted cognitive training) | Experimental | Other: Computer-Assisted Cognitive Training, Other: Questionnaire AdministrationPatients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks. |
| Arm II (wait-list) | Active comparator | Other: Questionnaire Administration, Procedure: Standard Follow-Up CarePatients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Breast cancer (stage 0, I, II, III), 18 months to 5 years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors)
- Able to read, write, and speak English
- Mini Mental State Exam score greater than or equal to 19
- Have reliable internet and daily access to computer with audio/speakers
- Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for 2-3 in person assessments over the 12-13 weeks of the study
Key exclusion criteria (14 listed)
- History of multiple cancers
- History of central nervous system (CNS) disease, CNS radiation, intrathecal therapy, or CNS surgery
- History of traumatic brain injury
- Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer's disease, Parkinson's disease
- Self-report of learning disabilities
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 TrainingParticipate in Cogmed computerized working memory training | Other | Arm I (computer-assisted cognitive training) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (computer-assisted cognitive training), Arm II (wait-list) |
| Standard Follow-Up CareUndergo standard follow-up care | Procedure or surgery | Arm II (wait-list) |
Primary outcome
Attrition rate
Time frame: Up to 7 weeks
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Percentage of participants retained in the study
Time frame: Up to 7 weeks
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Percentage of participants who are recruited
Time frame: Up to 7 weeks
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Satisfaction, measured by the satisfaction survey
Time frame: Up to 7 weeks
Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey.
7 secondary outcomes
Anxiety
Time frame: Baseline to up to 7 weeks
Cognition
Time frame: Baseline to up to 7 weeks
Depression
Time frame: Baseline to up to 7 weeks
Executive Function
Time frame: Baseline to up to 7 weeks
Fatigue
Time frame: Baseline to up to 7 weeks
Verbal Working Memory
Time frame: Baseline to up to 7 weeks
Visuo Spatial Working Memory
Time frame: Baseline to up to 7 weeks
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 13 Dec 2017.
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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.
Kathleen Shannon Dorcy principal investigator
Fred Hutch/University of Washington Cancer Consortium
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, Questionnaire Administration and Standard Follow-Up Care in people with Cancer Survivor and Stage 0 Breast Cancer, run by Fred Hutchinson 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 5 inclusion and 14 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 13 Dec 2017. 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 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?
Attrition rate (time frame: Up to 7 weeks). The study lists 4 primary outcomes in all. 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 13 Dec 2017.