Breast Cancer, Reasoning, and Activity Intervention
NCT04816006, Not applicable, Recruiting, Mayo Clinic
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Breast Cancer, Reasoning, and Activity Intervention | ClinicalTrials.gov |
| NCT number | NCT04816006 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 160 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Mayo Clinic | ClinicalTrials.gov |
| Conditions | Breast Cancer, Breast Neoplasms, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Cancer-related Cognitive Dysfunction | ClinicalTrials.gov |
| Interventions | Aerobic Exercise Training, Health Education (Active comparator) | ClinicalTrials.gov |
| First posted | 2021-03-25 | ClinicalTrials.gov |
| Last updated | 2026-09-08 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in inhibitory control | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in interference score on Stroop task, with positive values indicating greater inhibitory control. | ClinicalTrials.gov |
| Primary | Change in cognitive flexibility | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility | ClinicalTrials.gov |
| Primary | Change in executive function processing | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility | ClinicalTrials.gov |
| Primary | Change in short-term memory | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory | ClinicalTrials.gov |
| Primary | Change in verbal memory | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory | ClinicalTrials.gov |
| Primary | Change in working memory | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory | ClinicalTrials.gov |
| Primary | Change in brain volume | baseline (Month 0), post-intervention (month 6) | Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan | ClinicalTrials.gov |
| Primary | Change in white matter integrity | baseline (Month 0), post-intervention (month 6) | Change in fractional anisotropy as measured by diffusion MRI. | ClinicalTrials.gov |
| Primary | Change in resting state functional connectivity | baseline (Month 0), post-intervention (month 6) | Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence | ClinicalTrials.gov |
| Primary | Change in self-reported cognitive function | baseline (Month 0), post-intervention (month 6), follow up (month 12) | The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be used to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function. | ClinicalTrials.gov |
| Primary | Reach | baseline (Month 0) | Participation rate among eligible individuals contacted about the study. | ClinicalTrials.gov |
| Primary | Adoption | post-intervention (month 6) | Sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers | ClinicalTrials.gov |
| Primary | Change in Cardiorespiratory Fitness | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol. | ClinicalTrials.gov |
| Primary | Change in Cancer-related Fatigue | baseline (Month 0), post-intervention (month 6), follow up (month 12) | The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue. | ClinicalTrials.gov |
| Primary | Implementation | post-intervention (month 6) | Percent of session checklist items completed as intended | ClinicalTrials.gov |
| Primary | Maintenance | follow up (month 12) | The number of participants who withdraw during the follow-up period. | ClinicalTrials.gov |
| Primary | Change in processing speed | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed | ClinicalTrials.gov |
| Primary | Change in attention | baseline (Month 0), post-intervention (month 6), follow up (month 12) | Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40659404 | BACKGROUND | PubMed |
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R37CA252060 | Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training | EHLERS, DIANE KRISTEN | MAYO CLINIC ARIZONA | NATIONAL CANCER INSTITUTE | 2021 to 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Primary outcome | ConductCognition |
| Continuous Performance Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)