Memory Training Intervention for Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Memory Training Intervention for Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: memory training
* Behavioral: speed of processing training
* Behavioral: waitlist control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: memory training<br>memory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks | Behavioral: memory training<br>* 10 1-hour sessions over 6-8 weeks<br>|
| Experimental: speed of processing training<br>Speed of processing training 10 1-hour sessions delivered over 6-8 weeks | Behavioral: speed of processing training<br>* 10 1-hour sessions delivered over 6-8 weeks<br>|
| Experimental: waitlist control<br>Breast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control | Behavioral: waitlist control<br>* Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory Performance | Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors. | Baseline, immediately post intervention | 
| Memory Performance | Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors. | 2-month post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Cognitive Function | Preliminary efficacy established by objective neuropsychological tests and quality of life. | baseline, immediately post intervention | 
| Subjective Cognitive Function | Post intervention efficacy established by objective neuropsychological tests and quality of life. | 2-month follow-up | 
| Symptom distress | Preliminary symptom distress | baseline, immediately post intervention | 
| Symptom distress | Post intervention symptom distress | 2-month follow-up |