Breast Cancer Clinical Trial
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Female
Aged 21 years or older
First, primary diagnosis of Stage I-III breast cancer
Scheduled to receive chemotherapy for 3-6 months. While evidence suggests declines in cognition and brain health due to cancer may be evident both in women who receive and who do not receive chemotherapy, those receiving chemotherapy consistently experience the greatest changes.
Has received no more than one cycle of chemotherapy
Agree to be randomized to one of the intervention components
Owns an Android or iPhone smartphone
Fitbit specific criteria:
Compatible mobile device, laptop computer, or desktop computer
Willingness to continuously wear the Fitbit device during waking hours for the duration of the study period. Individuals not willing to wear the Fitbit during sleep will be eligible to participate.
Willingness and ability to charge the Fitbit device at home every 3-4 days and synchronize the Fitbit device multiple times daily.
English reading and speaking
Receive physician's clearance to participate in an exercise program
Provide written informed consent to participate in the study
No history or evidence of dementia (score >21 on the Modified Telephone Interview for Cognitive Status [TICS-M].73
Exclusion Criteria:
Males. Breast cancer is often classified specifically as female breast cancer, as 99% of cases occur in women. Our small sample size does not statistically justify the inclusion of males in this study. As such, only female subjects will be included in this research
Is scheduled to receive <3 months or >6 months of chemotherapy
Has received 2+ cycles of chemotherapy at enrollment
Stage 0 breast cancer diagnosis or metastatic disease
Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence)
Is not cleared to participate in exercise by a physician.
Unwilling to complete baseline behavioral, neurocognitive, and patient-reported assessments (accelerometry, cognitive tasks, questionnaires)
Unwilling to be randomized
Unwilling to continuously wear and regularly sync/charge the Fitbit device during the study period.
Unable to read and speak in English
Unwilling to provide written informed consent to participate
Cognitive impairment (score <21 on the TICS-M) prior to baseline assessment
History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal
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There is 1 Location for this study
Omaha Nebraska, 68198, United States
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