Breast CancerNCT01497015
Memory Training Intervention for Breast Cancer Survivors
A study testing memory training and speed of processing training in people with Breast Cancer, run by Indiana University at 1 site in United States.
Trial summary
This is a randomized controlled trial to evaluate the ACTIVE memory training intervention and ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific aims and hypotheses are: Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- memory training and speed of processing training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2012
- 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
- female gender (breast cancer is rare in men);
- self-reported memory impairment and desire for treatment (to focus on BCS in greatest need);
- first diagnosis of non-metastatic breast cancer (to control for multiple treatments or brain metastases in women with recurrent or metastatic disease);
- ≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy (reduce confounding factors related to acute effects of treatment);32
- age ≥ 40 years (our prior studies indicate approximately 75% of BCS meet this criterion and reduce sample variability);
- post-menopausal (majority are post-menopausal at diagnosis and reduce sample variability); and
- able to read, write, understand, and speak English (to ensure informed consent).
Who cannot join
- Women will be excluded if they have other co-morbidities or deficits that would sufficiently impair performance or inhibit cognitive training including:
- substantial cognitive decline (score < 24 on the Mini Mental State Exam (MMSE);33
- history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia, Alzheimer disease, or Parkinson disease;
- cranial radiation therapy or intrathecal therapy;
- current active major depression or substance abuse or history of bipolar disorder, psychosis, schizophrenia, or learning disability;
- history of or current other cancer except for basal cell skin cancer; or
- receiving other cognitive training (to avoid exposure to other training).
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial to evaluate the ACTIVE memory training intervention and ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific aims and hypotheses are:
Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors (BCS).
Read more
Hypothesis 1: BCS assigned to the memory intervention arm will perceive the intervention as more acceptable and useful than BCS assigned to the attention control condition.
Aim 2: Establish preliminary efficacy of the ACTIVE memory training intervention relative to the attention control and no-contact control conditions.
Hypothesis 2: Memory training will result in greater memory enhancement immediately post and 2-months post-intervention relative to attention control or no-contact control conditions.
Read the detailed description
Memory deficits are a prevalent, bothersome, and potentially debilitating symptom for millions of breast cancer survivors (BCS). Evidence-based treatment is difficult because there has been little intervention research in this area. Memory training may be a viable treatment option for BCS in need. Therefore, the purpose of this study is to examine the acceptability, usefulness, and preliminary efficacy of the memory training intervention from the Advanced Cognitive Training in Vital Elderly (ACTIVE) trial, the largest controlled trial of cognitive interventions in the behavioral sciences. The memory training intervention will be compared to attention control and no-contact control groups. Specific aims are to (1) evaluate the acceptability and usefulness of the memory intervention in BCS and (2) establish preliminary efficacy of the ACTIVE memory training intervention relative to attention control and no-contact control conditions. Acceptability and usefulness will be assessed through self-report. Memory will be assessed through objective neuropsychological tests. A total of 108 eligible BCS will be randomized to memory training, attention control, or no-contact control. A blinded and trained tester will perform data collection and neuropsychological testing at three time points: baseline prior to the intervention, immediately post-intervention, and 2 months post-intervention. Findings will provide information about the acceptability, usefulness, and preliminary efficacy of the ACTIVE memory training intervention on memory performance in BCS. Positive results will lead to a larger, full-scale study to determine efficacy of memory training interventions for BCS. Nursing interventional research in this area is vital to the development of evidence-based interventions to address memory deficits in BCS.
- Conditions
- Breast Cancer
- Being tested
- memory training, speed of processing training, waitlist control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memory trainingBehavioural
10 1-hour sessions over 6-8 weeks
speed of processing trainingBehavioural
10 1-hour sessions delivered over 6-8 weeks
waitlist controlBehavioural
Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.
| Study group | Role | What they receive |
|---|---|---|
| memory training | Experimental | memory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks Receives: Behavioral: memory training |
| speed of processing training | Experimental | Speed of processing training 10 1-hour sessions delivered over 6-8 weeks Receives: Behavioral: speed of processing training |
| waitlist control | Experimental | Breast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control Receives: Behavioral: waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory Performance
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
Measured: Baseline, immediately post intervention
Memory Performance
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
Measured: 2-month post intervention
Secondary outcomes (4)
Subjective Cognitive Function
Preliminary efficacy established by objective neuropsychological tests and quality of life.
Measured: baseline, immediately post intervention
Subjective Cognitive Function
Post intervention efficacy established by objective neuropsychological tests and quality of life.
Measured: 2-month follow-up
Symptom distress
Preliminary symptom distress
Measured: baseline, immediately post intervention
Symptom distress
Post intervention symptom distress
Measured: 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionDec 2012
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 Indiana 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane Von Ah, Indiana University
- Investigators
- Diane Von Ah, PhD, RN, CNA, Principal investigator, Indiana UniversityAndrew Saykin, PsyD, Study director, Indiana UniversityFrederick Unverzagt, PhD, Study director, Indiana UniversityJanet Carpenter, PhD, RN, Study director, Indiana UniversityPatrick Monahan, PhD, Study director, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497015
- Sponsor's protocol ID
- 64194
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2011
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Training Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01497015
- Acronym / sponsor ID
- 64194
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Dec 2011 (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 is a randomized controlled trial to evaluate the ACTIVE memory training intervention and ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific aims and hypotheses are:
Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors (BCS).
Hypothesis 1: BCS assigned to the memory intervention arm will perceive the intervention as more acceptable and useful than BCS assigned to the attention control condition.
Aim 2: Establish preliminary efficacy of the ACTIVE memory training intervention relative to the attention control and no-contact control conditions.
Hypothesis 2: Memory training will result in greater memory enhancement immediately post and 2-months post-intervention relative to attention control or no-contact control conditions.
Detailed description
Memory deficits are a prevalent, bothersome, and potentially debilitating symptom for millions of breast cancer survivors (BCS). Evidence-based treatment is difficult because there has been little intervention research in this area. Memory training may be a viable treatment option for BCS in need. Therefore, the purpose of this study is to examine the acceptability, usefulness, and preliminary efficacy of the memory training intervention from the Advanced Cognitive Training in Vital Elderly (ACTIVE) trial, the largest controlled trial of cognitive interventions in the behavioral sciences. The memory training intervention will be compared to attention control and no-contact control groups. Specific aims are to (1) evaluate the acceptability and usefulness of the memory intervention in BCS and (2) establish preliminary efficacy of the ACTIVE memory training intervention relative to attention control and no-contact control conditions. Acceptability and usefulness will be assessed through self-report. Memory will be assessed through objective neuropsychological tests. A total of 108 eligible BCS will be randomized to memory training, attention control, or no-contact control. A blinded and trained tester will perform data collection and neuropsychological testing at three time points: baseline prior to the intervention, immediately post-intervention, and 2 months post-intervention. Findings will provide information about the acceptability, usefulness, and preliminary efficacy of the ACTIVE memory training intervention on memory performance in BCS. Positive results will lead to a larger, full-scale study to determine efficacy of memory training interventions for BCS. Nursing interventional research in this area is vital to the development of evidence-based interventions to address memory deficits in BCS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| memory training | Experimental | Behavioral: memory trainingmemory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks |
| speed of processing training | Experimental | Behavioral: speed of processing trainingSpeed of processing training 10 1-hour sessions delivered over 6-8 weeks |
| waitlist control | Experimental | Behavioral: waitlist controlBreast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- female gender (breast cancer is rare in men);
- self-reported memory impairment and desire for treatment (to focus on BCS in greatest need);
- first diagnosis of non-metastatic breast cancer (to control for multiple treatments or brain metastases in women with recurrent or metastatic disease);
- ≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy (reduce confounding factors related to acute effects of treatment);32
- age ≥ 40 years (our prior studies indicate approximately 75% of BCS meet this criterion and reduce sample variability);
Key exclusion criteria (7 listed)
- Women will be excluded if they have other co-morbidities or deficits that would sufficiently impair performance or inhibit cognitive training including:
- substantial cognitive decline (score < 24 on the Mini Mental State Exam (MMSE);33
- history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia, Alzheimer disease, or Parkinson disease;
- cranial radiation therapy or intrathecal therapy;
- current active major depression or substance abuse or history of bipolar disorder, psychosis, schizophrenia, or learning disability;
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 |
|---|---|---|
| memory training10 1-hour sessions over 6-8 weeks | Behavioural | memory training |
| speed of processing training10 1-hour sessions delivered over 6-8 weeks | Behavioural | speed of processing training |
| waitlist controlBreast cancer survivors will receive the speed of processing training compact disc in the mail after study completion. | Behavioural | waitlist control |
Primary outcome
Memory Performance
Time frame: Baseline, immediately post intervention
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
Memory Performance
Time frame: 2-month post intervention
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
4 secondary outcomes
Subjective Cognitive Function
Time frame: baseline, immediately post intervention
Subjective Cognitive Function
Time frame: 2-month follow-up
Symptom distress
Time frame: baseline, immediately post intervention
Symptom distress
Time frame: 2-month follow-up
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 23 Feb 2023.
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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.
Diane Von Ah, PhD, RN, CNA principal investigator
Indiana University
Andrew Saykin, PsyD study director
Indiana University
Frederick Unverzagt, PhD study director
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing memory training and speed of processing training in people with Breast Cancer, run by Indiana 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 7 inclusion and 7 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 23 Feb 2023. 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?
Memory Performance (time frame: Baseline, immediately post intervention). The study lists 2 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 23 Feb 2023.