Memory Training Intervention for Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: memory training; Behavioral: speed of processing training; Behavioral: waitlist control

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Diane Von Ah, PhD, RN, CNA, Indiana University; Study Director: Andrew Saykin, PsyD, Indiana University; Study Director: Frederick Unverzagt, PhD, Indiana University; Study Director: Janet Carpenter, PhD, RN, Indiana University; Study Director: Patrick Monahan, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (Estimate): December 22, 2011

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 64194