Breast CarcinomaNCT01641068
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
A study testing Cognitive Intervention, Educational Intervention and Functional Magnetic Resonance Imaging in people with Breast Carcinoma and Cancer Survivor, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to examine thinking abilities, mood, and quality of life in cancer survivors before and after an 8-week group-based memory and thinking skills workshop. Research participants will include people treated for cancer in the past. Read more about this study
- Who is it for?
- Ages 21 to 90 years, women only
- Conditions the study is for
- Breast Carcinoma, Cancer Survivor, Cognitive Side Effects of Cancer Therapy
- What is being tested?
- Cognitive Intervention, Educational Intervention and Functional Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2012to 1 Jan 2018
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment
- Prior treatment of gynecologic or breast cancer with chemotherapy
- Completion of treatment (e.g., chemotherapy, radiation therapy, surgery, etc.) for gynecologic or breast cancer 6 months or greater in the past
- Able to comprehend and speak English
- For the subset of participants who will undergo magnetic resonance imaging (MRI), ability to withstand lying down in small area (MRI scanner) for 50 minutes
- Completion of successful fMRI safety screening
- Able to give informed consent
- Able to undergo informed consent procedures and 3 hours of testing, plus 8 1-hour cognitive rehabilitation sessions with breaks
Who cannot join
- Ongoing treatment for ovarian or other cancer (e.g., chemotherapy, radiation, surgery, etc.)
- Cancer onset before the age of 21
- Unstable medical problems (such as unstable heart disease, unstable hypertension, diabetes in poor control, respiratory disease complicated by hypoxia or hypercapnia, infectious illnesses, unstable thyroid dysfunction, currently hospitalized)
- History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization; mild depression or stable anti-depressants, and anti-seizure medications are acceptable; anti-anxiety medications may be acceptable
- Current alcohol over-use as defined by currently consuming 4 drinks or more per day or binge drinking (6 or more drinks in one night) within the past week
- History of or current neurological illness that significantly impacts cognition (e.g. stroke, multiple sclerosis, Parkinson's disease, Alzheimer's disease, head injury, epilepsy, etc)
Show all 13Show fewer
- History of brain injury that significantly impacted cognition; as indicated responses on the Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) greater or equal to any of the following: 30 minutes or more of loss of consciousness (LOC), two or more mild cases within two weeks of each other, or any injury with loss of consciousness before the age of 15
- History of central nervous system (CNS) tumor
- A score of 25 or more on the Patient Health Questionnaire (PHQ-9) on the first visit
- A score of 26 or below on the Mini Mental Status Exam (MMSE) triggers a review by an investigational team before enrolling
- A score above 45 on the Wender Utah Rating Scale for attention deficit disorder (ADD) (WURS)
- For the subset of participants undergoing neuroimaging:
- Medical history or devices which make an MRI unsafe or uncomfortable (e.g., magnetic rods or pins, metal plates or screws, pacemaker)
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: Behavioral and Neural Indices of Cognitive Rehabilitation in Women's Cancer: A Pilot Study
The purpose of this study is to examine thinking abilities, mood, and quality of life in cancer survivors before and after an 8-week group-based memory and thinking skills workshop. Research participants will include people treated for cancer in the past. Researchers would like to know if there is a relationship between baseline performance on timed attention and memory tasks before receiving memory and thinking skills workshop designed to improve cognition, and performance on such tasks after the workshop.
Read the detailed description
PRIMARY OBJECTIVES:
- To objectively assess changes in cognitive performance and quality of life (QOL) pre and post participation in a cognitive rehabilitation intervention in gynecologic and breast cancer survivors who have undergone chemotherapy.
II. To measure changes in neural function as measured by functional magnetic resonance imaging (fMRI) blood oxygenation level dependent (BOLD) signal and corresponding behavioral responses while performing cognitive tasks.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (Skills workshop): Patients participate in a memory and thinking skills workshop once weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
ARM II (Education workshop): Patients participate in education workshop for 7 weeks 1-hour duration group focusing on the brain and cognition. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
- Conditions
- Breast Carcinoma, Cancer Survivor, Cognitive Side Effects of Cancer Therapy, Malignant Female Reproductive System Neoplasm
- Being tested
- Cognitive Intervention, Educational Intervention, Functional Magnetic Resonance Imaging, Memory Intervention, Quality-of-Life Assessment
- Keywords
- Memory, Attention, Chemo-brain, Survivor, Treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive InterventionOther
Participate in memory and thinking skills workshop
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Participate in workshops focusing on increasing knowledge and education on the brain and cognition
Functional Magnetic Resonance ImagingProcedure or surgery
Also called fMRI, FUNCTIONAL MRI
Undergo functional neuroimaging
Memory InterventionOther
Participate in memory and thinking skills workshop
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (memory and thinking skills workshop) | Experimental | Patients participate in a memory and thinking skills workshop once weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3). Receives: Other: Cognitive Intervention; Procedure: Functional Magnetic Resonance Imaging; Other: Memory Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (Education Workshop) | Active comparator | Patients participate in 7 weekly 1-hour group workshops focusing on increasing knowledge and education on the brain and cognition. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3). Patients are then given the option to participate in the memory and thinking skills workshop. Receives: Other: Educational Intervention; Procedure: Functional Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire
Participants respond to questions about their quality of life. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Measured: Pre-workshop to 7 weeks post-workshop
Change in score on the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire
Participants respond to questions about their perceived cognitive function. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Measured: Pre-workshop to 7 weeks post-workshop
Changes in neural function measured by fMRI BOLD signal
MRI functional imaging assessments while performing cognitive tasks.
Measured: Pre-workshop to 7 weeks post-workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study start12 Sep 2012
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heidi Gray, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641068
- Sponsor's protocol ID
- 7750
- Other IDs
- NCI-2012-01035, 7750, P30CA015704
- Status last verified
- Nov 2019
- First submitted
- 12 Jul 2012
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neural Indices of Cognitive Rehabilitation in Women's Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT01641068
- Acronym / sponsor ID
- 7750
- Conditions
- Breast Carcinoma, Cancer Survivor, Cognitive Side Effects of Cancer Therapy, Malignant Female Reproductive System Neoplasm
- Keywords
- Memory, Attention, Chemo-brain, Survivor, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Sep 2012 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 16 Jul 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.
The purpose of this study is to examine thinking abilities, mood, and quality of life in cancer survivors before and after an 8-week group-based memory and thinking skills workshop. Research participants will include people treated for cancer in the past. Researchers would like to know if there is a relationship between baseline performance on timed attention and memory tasks before receiving memory and thinking skills workshop designed to improve cognition, and performance on such tasks after the workshop.
Detailed description
PRIMARY OBJECTIVES:
- To objectively assess changes in cognitive performance and quality of life (QOL) pre and post participation in a cognitive rehabilitation intervention in gynecologic and breast cancer survivors who have undergone chemotherapy.
II. To measure changes in neural function as measured by functional magnetic resonance imaging (fMRI) blood oxygenation level dependent (BOLD) signal and corresponding behavioral responses while performing cognitive tasks.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (Skills workshop): Patients participate in a memory and thinking skills workshop once weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
ARM II (Education workshop): Patients participate in education workshop for 7 weeks 1-hour duration group focusing on the brain and cognition. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
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 (memory and thinking skills workshop) | Experimental | Other: Cognitive Intervention, Procedure: Functional Magnetic Resonance Imaging, Other: Memory Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients participate in a memory and thinking skills workshop once weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3). |
| Arm II (Education Workshop) | Active comparator | Other: Educational Intervention, Procedure: Functional Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients participate in 7 weekly 1-hour group workshops focusing on increasing knowledge and education on the brain and cognition. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3). Patients are then given the option to participate in the memory and thinking skills workshop. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment
- Prior treatment of gynecologic or breast cancer with chemotherapy
- Completion of treatment (e.g., chemotherapy, radiation therapy, surgery, etc.) for gynecologic or breast cancer 6 months or greater in the past
- Able to comprehend and speak English
- For the subset of participants who will undergo magnetic resonance imaging (MRI), ability to withstand lying down in small area (MRI scanner) for 50 minutes
Key exclusion criteria (13 listed)
- Ongoing treatment for ovarian or other cancer (e.g., chemotherapy, radiation, surgery, etc.)
- Cancer onset before the age of 21
- Unstable medical problems (such as unstable heart disease, unstable hypertension, diabetes in poor control, respiratory disease complicated by hypoxia or hypercapnia, infectious illnesses, unstable thyroid dysfunction, currently hospitalized)
- History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization; mild depression or stable anti-depressants, and anti-seizure medications are acceptable; anti-anxiety medications may be acceptable
- Current alcohol over-use as defined by currently consuming 4 drinks or more per day or binge drinking (6 or more drinks in one night) within the past week
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 |
|---|---|---|
| Cognitive InterventionParticipate in memory and thinking skills workshop | Other | Arm I (memory and thinking skills workshop) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalParticipate in workshops focusing on increasing knowledge and education on the brain and cognition | Other | Arm II (Education Workshop) |
| Functional Magnetic Resonance ImagingAlso: fMRI, FUNCTIONAL MRIUndergo functional neuroimaging | Procedure or surgery | Arm I (memory and thinking skills workshop), Arm II (Education Workshop) |
| Memory InterventionParticipate in memory and thinking skills workshop | Other | Arm I (memory and thinking skills workshop) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (memory and thinking skills workshop), Arm II (Education Workshop) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (memory and thinking skills workshop), Arm II (Education Workshop) |
Primary outcome
Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire
Time frame: Pre-workshop to 7 weeks post-workshop
Participants respond to questions about their quality of life. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Change in score on the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire
Time frame: Pre-workshop to 7 weeks post-workshop
Participants respond to questions about their perceived cognitive function. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Changes in neural function measured by fMRI BOLD signal
Time frame: Pre-workshop to 7 weeks post-workshop
MRI functional imaging assessments while performing cognitive tasks.
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 8 Nov 2019.
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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.
Heidi Gray 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 Cognitive Intervention, Educational Intervention and Functional Magnetic Resonance Imaging in people with Breast Carcinoma and Cancer Survivor, run by University of Washington 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 8 inclusion and 13 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 8 Nov 2019. 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?
Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire (time frame: Pre-workshop to 7 weeks post-workshop). The study lists 3 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 8 Nov 2019.