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Memory Training Intervention for Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
memory training
speed of processing training
waitlist control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

memory training

speed of processing training

waitlist control

Arm Description

memory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks

Speed of processing training 10 1-hour sessions delivered over 6-8 weeks

Breast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective Cognitive Function
Preliminary efficacy established by objective neuropsychological tests and quality of life.
Subjective Cognitive Function
Post intervention efficacy established by objective neuropsychological tests and quality of life.
Symptom distress
Preliminary symptom distress
Symptom distress
Post intervention symptom distress

Full Information

First Posted
December 15, 2011
Last Updated
February 21, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01497015
Brief Title
Memory Training Intervention for Breast Cancer Survivors
Official Title
Memory Training Intervention for Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
memory training
Arm Type
Experimental
Arm Description
memory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks
Arm Title
speed of processing training
Arm Type
Experimental
Arm Description
Speed of processing training 10 1-hour sessions delivered over 6-8 weeks
Arm Title
waitlist control
Arm Type
Experimental
Arm Description
Breast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control
Intervention Type
Behavioral
Intervention Name(s)
memory training
Intervention Description
10 1-hour sessions over 6-8 weeks
Intervention Type
Behavioral
Intervention Name(s)
speed of processing training
Intervention Description
10 1-hour sessions delivered over 6-8 weeks
Intervention Type
Behavioral
Intervention Name(s)
waitlist control
Intervention Description
Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.
Primary Outcome Measure Information:
Title
Memory Performance
Description
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
Time Frame
Baseline, immediately post intervention
Title
Memory Performance
Description
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
Time Frame
2-month post intervention
Secondary Outcome Measure Information:
Title
Subjective Cognitive Function
Description
Preliminary efficacy established by objective neuropsychological tests and quality of life.
Time Frame
baseline, immediately post intervention
Title
Subjective Cognitive Function
Description
Post intervention efficacy established by objective neuropsychological tests and quality of life.
Time Frame
2-month follow-up
Title
Symptom distress
Description
Preliminary symptom distress
Time Frame
baseline, immediately post intervention
Title
Symptom distress
Description
Post intervention symptom distress
Time Frame
2-month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Von Ah, PhD, RN, CNA
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Saykin, PsyD
Organizational Affiliation
Indiana University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Frederick Unverzagt, PhD
Organizational Affiliation
Indiana University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Janet Carpenter, PhD, RN
Organizational Affiliation
Indiana University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Patrick Monahan, PhD
Organizational Affiliation
Indiana University
Official's Role
Study Director
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Memory Training Intervention for Breast Cancer Survivors

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