Clinical trial · Interventional
The Patterns of Activity and Cognition During Treatment (PACT) Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attentional Control | Behavioral | — | UNRESOLVED |
| Physical Activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Core Component (tele-coaching, emails, smartphone app & Fitbit)
- description
- 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.
- interventionNames
- Behavioral: Attentional Control
- type
- EXPERIMENTAL
- label
- Move (tele-coaching calls, smartphone app & Move goals & badges)
- description
- 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.
- interventionNames
- Behavioral: Physical Activity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available