Memory Training Intervention for Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: speed of processing training; Behavioral: waitlist control; Behavioral: memory training

• Registration Number: NCT01497015
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-22
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
speed of processing training	speed of processing training	Speed of processing training 10 1-hour sessions delivered over 6-8 weeks
waitlist control	waitlist control	Breast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control
memory training	memory training	memory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks

Primary Outcome Measures

Name	Time	Method
Memory Performance	2-month post intervention	Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.

Secondary Outcome Measures

Name	Time	Method
Symptom distress	2-month follow-up	Post intervention symptom distress
Subjective Cognitive Function	2-month follow-up	Post intervention efficacy established by objective neuropsychological tests and quality of life.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States