Clinical trial NCT01497015: Memory Training Intervention for Breast Cancer Survivors
Official title: Memory Training Intervention for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 88
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Memory Performance
timeFrame: Baseline, immediately post intervention
measure: Memory Performance
timeFrame: 2-month post intervention
Secondary outcomes:
measure: Subjective Cognitive Function
timeFrame: baseline, immediately post intervention
measure: Subjective Cognitive Function
timeFrame: 2-month follow-up
measure: Symptom distress
timeFrame: baseline, immediately post intervention
measure: Symptom distress
timeFrame: 2-month follow-up
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Diane Von Ah, PhD, RN, CNA
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Andrew Saykin, PsyD
role: STUDY_DIRECTOR
affiliation: Indiana University
name: Frederick Unverzagt, PhD
role: STUDY_DIRECTOR
affiliation: Indiana University
name: Janet Carpenter, PhD, RN
role: STUDY_DIRECTOR
affiliation: Indiana University
name: Patrick Monahan, PhD
role: STUDY_DIRECTOR
References: