Indiana University
Indianapolis, Indiana, 46202, United States
NCT Number: NCT01497015
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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Notify Me40 year and older
Female
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women will be excluded if they have other co-morbidities or deficits that would sufficiently impair performance or inhibit cognitive training including:
10 1-hour sessions over 6-8 weeks
10 1-hour sessions delivered over 6-8 weeks
Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.
Time frame: Baseline, immediately post intervention
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
Time frame: 2-month post intervention
Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.
Time frame: baseline, immediately post intervention
Preliminary efficacy established by objective neuropsychological tests and quality of life.
Time frame: 2-month follow-up
Post intervention efficacy established by objective neuropsychological tests and quality of life.
Time frame: baseline, immediately post intervention
Preliminary symptom distress
Time frame: 2-month follow-up
Post intervention symptom distress
Indiana University
Other
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