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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| memory training | Experimental | memory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks |
|
| speed of processing training | Experimental | Speed of processing training 10 1-hour sessions delivered over 6-8 weeks |
|
| waitlist control | Experimental | Breast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| memory training | Behavioral | 10 1-hour sessions over 6-8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Memory Performance | Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors. | Baseline, immediately post intervention |
| Memory Performance | Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors. | 2-month post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Cognitive Function | Preliminary efficacy established by objective neuropsychological tests and quality of life. | baseline, immediately post intervention |
| Subjective Cognitive Function |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Von Ah, PhD, RN, CNA | Indiana University | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 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. |
|
Post intervention efficacy established by objective neuropsychological tests and quality of life.
| 2-month follow-up |
| Symptom distress | Preliminary symptom distress | baseline, immediately post intervention |
| Symptom distress | Post intervention symptom distress | 2-month follow-up |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |