NCT04562987

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cancer-related cognitive impairment (CRCI) is a research priority due to its rising prevalence and dramatic impacts on survivors' quality of life and health long-term. Strong evidence supports the efficacy of physical activity (PA) for improving cognitive function and key CRCI correlates. The aim of the proposed study is to pilot test an innovative, mHealth intervention designed to ameliorate CRCI in women receiving chemotherapy for breast cancer. This study will employ an efficient 2x2 factorial design to compare PA prescriptions targeting frequent PA of any intensity and reduced daily sitting (Move); aerobic exercise (consistent with PA guidelines for cancer survivors; Exercise); both (Move+Exercise); or none (Core). The main and interactive effects of these intervention components on CRCI and its underlying mechanisms will be tested across the breast cancer trajectory. Aim 1: This pilot study aims to test the feasibility and acceptability of the mHealth intervention in 40 women receiving chemotherapy for breast cancer. 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 a baseline orientation and 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) 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 CRCI correlates. Exploratory outcomes will be measured at pre- and post-intervention and include patient-reported outcomes (e.g., fatigue, depressive symptoms). Participants will also complete brief ecological momentary assessments (EMAs) on their mobile phones across four 14-day measurement bursts to further explore associations among behavioral patterns, cognition, and CRCI correlates. To test the specific aims, women diagnosed with breast cancer and scheduled to receive 3-6 months of chemotherapy (N=40) will be randomized to receive select mHealth intervention components, including Core (attentional control), Move, Exercise, or Move+Exercise (n=10 each condition). Data will be analyzed using descriptive statistics and axial coding (Aim 1); analysis of covariance and standard mean difference (Aim 2 and Exploratory); and hierarchical linear modeling (Exploratory). Findings will provide the necessary pilot data to support a grant application for a fully-powered trial.

Conditions

• Breast Neoplasms
• Breast Cancer Female

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-15
• Primary completion: 2022-07-07
• Completion: 2022-07-07
• First posted: 2020-09-24
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States