Memory Training Intervention for Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Memory Training Intervention for Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497015
• Other study ID #: 64194
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• memory training
10 1-hour sessions over 6-8 weeks
• speed of processing training
10 1-hour sessions delivered over 6-8 weeks
• waitlist control
Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory Performance	Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.	Baseline, immediately post intervention
Primary	Memory Performance	Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.	2-month post intervention
Secondary	Subjective Cognitive Function	Preliminary efficacy established by objective neuropsychological tests and quality of life.	baseline, immediately post intervention
Secondary	Subjective Cognitive Function	Post intervention efficacy established by objective neuropsychological tests and quality of life.	2-month follow-up
Secondary	Symptom distress	Preliminary symptom distress	baseline, immediately post intervention
Secondary	Symptom distress	Post intervention symptom distress	2-month follow-up