N/A
Completed N=34
Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery
Malignant Gastrointestinal Neoplasm · Malignant Peritoneal Neoplasm
Source: ClinicalTrials.gov NCT02356471 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period — 9 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period |
9 | — |
| SECONDARY Change in Daily Steps for Participants Before and After Major Oncologic Surgery |
-2573 | — |
| SECONDARY Change in Short Physical Performance Battery (SPPB) |
— | — |
| SECONDARY Change in Duration of 400-meter Walk |
-69.5 | — |
| SECONDARY Change in Pepper Assessment Tool for Disability (PAT-D) |
— | — |
| SECONDARY Change in the Mobility Assessment Tool-Short Form (MAT-sf). |
4.52 | — |
| SECONDARY Change in CHAMPS Between the Pre- and Post-operative Period |
-1 | — |
| SECONDARY Change in Health-related Quality of Life (FACT-G) Questionnaire |
-1 | — |
| SECONDARY Change in Pain Assessment -Pain Visual Analog Scale, (PVAS) |
21 | — |
| SECONDARY Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS). |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) 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
Data sourced from ClinicalTrials.gov (NCT02356471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.