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

NCT ID: NCT04562987

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2022-07-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Core Component (tele-coaching, emails, smartphone app & Fitbit)

All participants will receive the Core component, which includes access to weekly tele-coaching, weekly emails from the interventionist, a smartphone app, and a Fitbit monitor. Tele-coaching will include discussion of general cancer-related and wellness topics, and the smartphone app will have basic activity monitoring features.

Group Type: ACTIVE_COMPARATOR

Attentional Control

Intervention Type: BEHAVIORAL

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

Move (tele-coaching calls, smartphone app & Move goals & badges)

Tele-coaching calls for Move participants will be based in social cognitive theory to encourage behavior adoption and goal setting focused on reducing prolonged sitting. Smartphone app features include activity monitoring that visualizes progress toward Move-based goals and goal achievement badges specific to Move.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

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.

Exercise (tele-coaching calls & smartphone app)

Tele-coaching calls for Exercise participants will be based in social cognitive theory to encourage behavior adoption and goal setting focused on engaging in 30 minutes of moderate-intensity physical activity per day (in 10+ minute bouts). Smartphone app features include activity monitoring that visualizes progress toward Exercise-based goals and goal achievement badges specific to Exercise.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

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.

Combo (Move+Exercise)

Includes tele-coaching that encourages behavior adoption and goal setting focused on reducing prolonged sitting and engaging in 30+ minutes of physical activity per day. Participants are able to visualize progress toward Move and Exercise goals and are eligible to receive achievement badges for Move and Exercise.

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura D Bilek, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1U54GM115458

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0736-19-FB

Identifier Type: -

Identifier Source: org_study_id