Clinical trial · Interventional
Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery
Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
- 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)
This pilot clinical trial studies how well consumer-based activity monitor works in evaluating and measuring activity of older patients with abdominal cancer undergoing surgery. Consumer-based activity monitor (CAM) may identify patients who are at-risk for increased post-surgery medical problems. With early identification of at-risk patients, CAM provide supervised exercise in the preoperative and postoperative periods to improve over mobility and potentially decrease preoperative complications among patients undergoing major abdominal surgery.
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 |
|---|---|---|---|
| Malignant Gastrointestinal Neoplasm | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Malignant Peritoneal Neoplasm | Malignant Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Management of Therapy Complications Fitbit Zip (portable pedometer device) | Device | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (consumer-based activity monitor)
- description
- Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.
- interventionNames
- Device: Management of Therapy Complications Fitbit Zip (portable pedometer device)
- Other: Questionnaire Administration
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
- Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period
- timeFrame
- 21 days
- description
- Feasibility will be defined as the number of patients who self-report wearing the CAM device at least 16 days of the 21 day period.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) \< 3 * Histologically or cytologically confirmed gastrointestinal or peritoneal malignancy * Scheduled for major open abdominal oncologic surgery * Able to walk without an assistive device * Able to complete a minimum of 4 days of in-home activity monitoring before operation * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document * Ability to understand and complete the study survey instruments in English Exclusion Criteria: * Cerebrovascular accident (CVA) or stroke within the past 6 months * Severe or symptomatic heart disease * Currently residing in nursing or assisted living facility * Neurologic disorder that impairs ambulation (e.g. Parkinson's) * Actively undergoing treatment for a psychiatric illness * Resting blood pressure \> 160/100 * Clinically evident cognitive and/or behavioral impairment that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoring * Current alcohol or other substance abuse or history of abuse within 6 months prior to screening * Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoring * Unable to understand and complete the study survey instruments in English
References
Publications (0)
Data not yet available