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Completed

NCT Number: NCT01497015

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

memory training

Behavioral

10 1-hour sessions over 6-8 weeks

Speed of Processing Training

Behavioral

10 1-hour sessions delivered over 6-8 weeks

Waitlist Control

Behavioral

Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.

Primary outcomes

  1. Memory Performance

    Time frame: Baseline, immediately post intervention

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

  2. Memory Performance

    Time frame: 2-month post intervention

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

Secondary outcomes

  1. Subjective Cognitive Function

    Time frame: baseline, immediately post intervention

    Preliminary efficacy established by objective neuropsychological tests and quality of life.

  2. Subjective Cognitive Function

    Time frame: 2-month follow-up

    Post intervention efficacy established by objective neuropsychological tests and quality of life.

  3. Symptom distress

    Time frame: baseline, immediately post intervention

    Preliminary symptom distress

  4. Symptom distress

    Time frame: 2-month follow-up

    Post intervention symptom distress

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 22, 2011
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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