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NCT04562987 · ClinicalTrials.gov registry record · NA
The Patterns of Activity and Cognition During Treatment (PACT) Study
A NA study, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04562987 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 12 participants.
The verdict
NCT04562987, a NA study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Aim 1: This pilot study tests the feasibility and acceptability of a mobile app-based behavioral intervention in 40 women receiving chemotherapy for breast cancer. Participants will be randomized to receive app components following a 2x2 factorial design. Feasibility will be assessed by participant recruitment yield, intervention adherence, contamination, and retention. Acceptability will be assessed by participant ratings and perceptions of intervention components as measured at post-intervention (1 month post-chemotherapy). Aim 2: Examine preliminary efficacy of the intervention components (i.e., Move, Exercise, Core) delivered alone (i.e., main effects) and in combination (i.e., interaction effects; Move+Exercise) on executive function and working memory at post-intervention. These data will inform the sample size needed for a fully-powered randomized controlled trial. Aim 2 outcomes will be measured at pre-intervention (before the first or second chemotherapy cycle) and post-intervention, and include accelerometry and neurocognitive testing. Exploratory Aim: Explore the effects of the intervention components on correlates of cancer-associated cognitive decline. Exploratory outcomes will be measured at pre- and post-intervention and include patient-reported outcomes, specifically cancer-related fatigue. Participants will also completed brief ecological momentary assessments (EMAs) their mobile phones across four 14-day measurement bursts at pre-intervention, mid-chemotherapy, and 1 month post-chemotherapy to further explore associations among behavioral patterns, cognition, and correlates.
Interventions
- BEHAVIORAL Physical Activity
- BEHAVIORAL Attentional Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2022-07-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04562987
The ClinicalTrials.gov registry entry for NCT04562987 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Physical Activity is the first listed.
NCT04562987 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04562987 about?
NCT04562987 is a clinical study titled "The Patterns of Activity and Cognition During Treatment (PACT) Study". Aim 1: This pilot study tests the feasibility and acceptability of a mobile app-based behavioral intervention in 40 women receiving chemotherapy for breast cancer. Participants will be randomized to receive app components following a 2x2 factorial design. Feasibility will be assessed by participant ...
What is the current status of trial NCT04562987?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2021-01-15. Estimated completion is 2022-07-07.
What interventions are being tested in trial NCT04562987?
The interventions under investigation include: Physical Activity (BEHAVIORAL), Attentional Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT04562987?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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