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

NCT04562987 | Completed DMC

• 2 other identifiers: 0736-19-FB1U54GM115458
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Breast Cancer Female

Keywords

breast cancer; physical activity; cognition; chemotherapy

Outcome Measures

Primary Outcomes (5)

• intervention attendance

  completion of telecoaching sessions

  1 month post-chemotherapy

• Participant satisfaction: survey

  usability survey

  1 month post-chemotherapy

• recruitment yield

  number of women who enroll compared to the number of contacts of eligible women required to obtain target sample size

  Baseline

• retention

  proportion of participants providing post-intervention data

  1 month post-chemotherapy

• acceptability of intervention: in-depth interview

  in-depth interview to gather participant perceptions on the acceptability and usefulness of the mobile app features

  1 month post-chemotherapy

Secondary Outcomes (7)

• Change in Stroop task performance

  Baseline, 1 month post-chemotherapy

• Change in Task-Switch task performance

  Baseline, 1 month post-chemotherapy

• Change in Trails task performance

  Baseline, 1 month post-chemotherapy

• Change in N-Back task performance

  Baseline, 1 month post-chemotherapy

• Change in Spatial Working Memory task performance

  Baseline, 1 month post-chemotherapy

Other Outcomes (2)

• Change in cancer-related Fatigue

  Baseline, 1 month post-chemotherapy

• Momentary symptoms

  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

Study Arms (4)

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

ACTIVE COMPARATOR

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.

Behavioral: Attentional Control

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

EXPERIMENTAL

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.

Behavioral: Physical Activity

Exercise (tele-coaching calls & smartphone app)

EXPERIMENTAL

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.

Behavioral: Physical Activity

Combo (Move+Exercise)

EXPERIMENTAL

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.

Behavioral: Physical Activity

Interventions

Physical Activity 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); Exercise (tele-coaching calls & smartphone app); Move (tele-coaching calls, smartphone app & Move goals & badges)

Attentional Control 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.

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

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• Wake Forest University: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura D Bilek, PT, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 24, 2020
• Study Start: January 15, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After primary manuscripts have been published.
• Access Criteria: To be determined upon research request.

Locations

US (1)