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Spots Global Cancer Trial Database for Memory Training Intervention for Breast Cancer Survivors

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Trial Identification

Brief Title: Memory Training Intervention for Breast Cancer Survivors

Official Title: Memory Training Intervention for Breast Cancer Survivors

Study ID: NCT01497015

Conditions

Breast Cancer

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.

Keywords

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Indiana University, Indianapolis, Indiana, United States

Contact Details

Name: Diane Von Ah, PhD, RN, CNA

Affiliation: Indiana University

Role: PRINCIPAL_INVESTIGATOR

Name: Andrew Saykin, PsyD

Affiliation: Indiana University

Role: STUDY_DIRECTOR

Name: Frederick Unverzagt, PhD

Affiliation: Indiana University

Role: STUDY_DIRECTOR

Name: Janet Carpenter, PhD, RN

Affiliation: Indiana University

Role: STUDY_DIRECTOR

Name: Patrick Monahan, PhD

Affiliation: Indiana University

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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