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Memory Training Intervention for Breast Cancer Survivors


Phase 2/Phase 3
40 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Memory Training Intervention for Breast Cancer Survivors


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.


Inclusion Criteria:



1. female gender (breast cancer is rare in men);

2. self-reported memory impairment and desire for treatment (to focus on BCS in greatest
need);

3. first diagnosis of non-metastatic breast cancer (to control for multiple treatments
or brain metastases in women with recurrent or metastatic disease);

4. ≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy (reduce
confounding factors related to acute effects of treatment);32

5. age ≥ 40 years (our prior studies indicate approximately 75% of BCS meet this
criterion and reduce sample variability);

6. post-menopausal (majority are post-menopausal at diagnosis and reduce sample
variability); and

7. able to read, write, understand, and speak English (to ensure informed consent).

Exclusion Criteria:

Women will be excluded if they have other co-morbidities or deficits that would
sufficiently impair performance or inhibit cognitive training including:

1. substantial cognitive decline (score < 24 on the Mini Mental State Exam (MMSE);33

2. history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia,
Alzheimer disease, or Parkinson disease;

3. cranial radiation therapy or intrathecal therapy;

4. current active major depression or substance abuse or history of bipolar disorder,
psychosis, schizophrenia, or learning disability;

5. history of or current other cancer except for basal cell skin cancer; or

6. receiving other cognitive training (to avoid exposure to other training).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Memory Performance

Outcome Description:

Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.

Outcome Time Frame:

Baseline, immediately post, and 2-month post intervention

Safety Issue:

No

Principal Investigator

Diane Von Ah, PhD, RN, CNA

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Institutional Review Board

Study ID:

64194

NCT ID:

NCT01497015

Start Date:

September 2008

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location
Indiana University Indianapolis, Indiana  46202