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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: Completed NA study, sponsored by University of Nebraska.

NCT04562987 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

completion of telecoaching sessions

Interventions

  • BEHAVIORAL Physical Activity
  • BEHAVIORAL Attentional Control

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2021-01-15
Est. Completion 2022-07-07
Phase NA
University of Nebraska

407 total trials

What the finished NCT04562987 record still lists

NCT04562987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Physical Activity is the first listed.

NCT04562987 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04562987's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04562987, the US trial registry maintained by the National Library of Medicine. NCT04562987 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.