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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04562987
Recruitment Status : Active, not recruiting
First Posted : September 24, 2020
Last Update Posted : May 5, 2022
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
Wake Forest University
Information provided by (Responsible Party):
Diane Ehlers, University of Nebraska

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Cancer Female Behavioral: Physical Activity Behavioral: Attentional Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Patterns of Activity and Cognition During Treatment (PACT) Study
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Core
All participants will receive the Core component, which includes access to weekly telecoaching, weekly emails from the interventionist, a smartphone app, and a Fitbit monitor. Telecoaching will include discussion of general cancer-related and wellness topics, and the smartphone app will have basic activity monitoring features.
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.

Experimental: Move
Telecoaching 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.
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.

Experimental: Exercise
Telecoaching 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.
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.

Experimental: Combo (Move+Exercise)
Includes telecoaching 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.
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.




Primary Outcome Measures :
  1. intervention attendance [ Time Frame: 1 month post-chemotherapy ]
    completion of telecoaching sessions

  2. Participant satisfaction: survey [ Time Frame: 1 month post-chemotherapy ]
    usability survey

  3. recruitment yield [ Time Frame: Baseline ]
    number of women who enroll compared to the number of contacts of eligible women required to obtain target sample size

  4. retention [ Time Frame: 1 month post-chemotherapy ]
    proportion of participants providing post-intervention data

  5. acceptability of intervention: in-depth interview [ Time Frame: 1 month post-chemotherapy ]
    in-depth interview to gather participant perceptions on the acceptability and usefulness of the mobile app features


Secondary Outcome Measures :
  1. Change in Stroop task performance [ Time Frame: Baseline, 1 month post-chemotherapy ]
    Interference score on Stroop task

  2. Change in Task-Switch task performance [ Time Frame: Baseline, 1 month post-chemotherapy ]
    Reaction time on Task-Switch

  3. Change in Trails task performance [ Time Frame: Baseline, 1 month post-chemotherapy ]
    Completion time of Trails

  4. Change in N-Back task performance [ Time Frame: Baseline, 1 month post-chemotherapy ]
    Correct responses on N-back

  5. Change in Spatial Working Memory task performance [ Time Frame: Baseline, 1 month post-chemotherapy ]
    Correct responses on Spatial Working Memory task

  6. Change in Auditory Verbal Learning Task (AVLT) performance [ Time Frame: Baseline, 1 month post-chemotherapy ]
    Total numbered recalled on AVLT

  7. Change in objective physical activity behavior [ Time Frame: Baseline, 1 month post-chemotherapy ]
    Objective activity behavior (average minutes of physical activity per day) will be measured using actigraphy.


Other Outcome Measures:
  1. Change in cancer-related Fatigue [ Time Frame: Baseline, 1 month post-chemotherapy ]
    The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue.

  2. Momentary symptoms [ Time Frame: 14 days 4 times per day at each of the following time points: baseline, mid-intervention (2-3 months from baseline), 1 month post-chemotherapy ]
    A brief ecological momentary assessment prompted to participants' smartphones will be used to measure momentary symptoms, including anxiety, stress, fatigue, focus, pain, and nausea.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562987


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-8440
Sponsors and Collaborators
University of Nebraska
National Institute of General Medical Sciences (NIGMS)
Wake Forest University
Investigators
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Principal Investigator: Diane K Ehlers, PhD University of Nebraska
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Responsible Party: Diane Ehlers, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT04562987    
Other Study ID Numbers: 736-19
1U54GM115458 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data will be available to other researchers upon request and approval by the PI.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After primary manuscripts have been published.
Access Criteria: To be determined upon research request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diane Ehlers, University of Nebraska:
breast cancer
physical activity
cognition
chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases