The Patterns of Activity and Cognition During Treatment (PACT) 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.

Conditions

• Breast Neoplasms
• Breast Cancer Female

Interventions

BEHAVIORAL

Physical Activity

Mobile app intervention delivered during chemotherapy for breast cancer that combines goal setting, behavioral monitoring, and goal achievement badges with telecoaching to achieve physical activity prescriptions.

BEHAVIORAL

Attentional Control

Mobile app intervention delivered during chemotherapy for breast cancer that includes telecoaching on general and cancer-related health topics and basic physical activity monitoring.

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• Wake Forest University

  collaborator OTHER

• University of Nebraska

  lead OTHER

Principal Investigators

• Laura D Bilek, PT, PhD · University of Nebraska

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-15

Primary Completion

2022-07-07

Completion

2022-07-07

Countries

• United States

Study Locations