Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04586530
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2020-09-29
Brief Title:
Telehealth and Memory Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction A Multi-Center Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAMS
Brief Summary:
The overall purpose of this trial is to confirm the efficacy of Memory and Attention Adaptation Training MAAT a cognitive-behavioral therapy CBT for treatment of chemotherapy-related cognitive dysfunction among female or male breast cancer survivors This is a multi-center multi-clinician randomized control trial MAAT vs supportive therapy attention control condition This trial will also evaluate a sub-sample of survivors pre-and post treatment with functional magnetic resonance imaging fMRI in a working memory task to evaluate pre-to-post treatment brain activation patterns to elucidate underlying mechanisms of clinical therapeutic change
Detailed Description:
The primary aim of this multi-site multi-clinician randomized controlled trial is to determine if Memory and Attention Adaptation Training MAAT a cognitive-behavioral therapy CBT intervention can improve self-reported and objectively measured cognitive functioning in breast cancer survivors who previously received chemotherapy Breast cancer survivors Stage I-III who were treated with chemotherapy 1-5 years prior to enrollment and who have subjective cognitive complaints may be eligible for this study After eligibility is confirmed participants will complete baseline assessments of subjective and objective memory and attention functioning as well as behavioral rating scales and will be randomized to MAAT or Supportive Therapy ST to control for therapist time and attention for 8 weeks Both treatments MAAT and ST will be delivered through videoconferencing using mobile smartphone laptop or other electronic device in order to reduce survivor travel or time away from work or family Data collection methods will include telephone- and web-administered measures of subjective and objective cognitive function as well as various behavioral ratings Outcome assessments will be conducted post-treatment and at 6-month follow-up It is hypothesized that MAAT participants will have significantly improved scores of self-reported cognitive impairments and objective neurocognitive test scores on verbal memory and processing speed at post-treatment and 6-month follow-up compared to participants randomized to ST In addition willing and eligible participants will be asked to complete a functional MRI working memory task at baseline and post-treatment to examine whether those who receive MAAT show greater increase in brain network activation than those who receive ST This may advance understanding of the neural mechanisms underlying improvement of objective and self-reported cognitive function after chemotherapy The sample size n100group will allow for a 10-15 drop out-rate and still provide 80 power to detect group differences using two Group MAAT vs ST by 3 time baseline posttreatment 6-month follow-up ANCOVA at alpha005 Potential baseline differences between MAAT and ST groups on primary outcome variables or other factors that may affect cognition eg anxiety fatigue or depression will be evaluated as potential covariates although such differences due to randomization are not anticipated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA244673-01A1 | NIH | None | httpsreporternihgovquickSearchR01CA244673-01A1 |