Memory Training Intervention for Breast Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Indiana University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01497015
First received: December 15, 2011
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Behavioral: memory training
Behavioral: speed of processing training
Behavioral: waitlist control
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Memory Training Intervention for Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Memory Performance [ Time Frame: Baseline, immediately post, and 2-month post intervention ] [ Designated as safety issue: No ]
    Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.


Secondary Outcome Measures:
  • Subjective Cognitive Function [ Time Frame: baseline, immediately and 2-month follow-up ] [ Designated as safety issue: No ]
    Preliminary efficacy established by objective neuropsychological tests and quality of life.


Estimated Enrollment: 91
Study Start Date: September 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: memory training
memory training
Behavioral: memory training
10 1-hour sessions over 6-8 weeks
Experimental: speed of processing training
Speed of processing training
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.

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497015

Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01497015     History of Changes
Other Study ID Numbers: 64194
Study First Received: December 15, 2011
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014