Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes

• Conditions: Cancer; Solid Tumor; Hematologic Malignancy

• Registration Number: NCT00300001
• Lead Sponsor: Community Cancer Care

Brief Summary

The primary research objective of this protocol is to evaluate the impact of integrating a home-based symptom monitoring system in the day-to-day care of cancer patients in community settings on the frequency of supportive symptom interventions, symptom severity, and quality of life.

Detailed Description

Patients will be randomly assigned to one of two groups. One group will be offered an Internet assisted home-based symptom reporting system Cancer Symptom Monitor (CSM) for a twelve-month study period. Patient and care team evaluations will be measured using quantitative and qualitative methods (via focus groups). The second group will receive "standard care" without home-based symptom monitoring. Both groups will be evaluated at baseline, 1, 2, 3, 6, 9, \& 12 months, for symptom levels and overall quality of life during the twelve-month study period.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-03
• Study First Submitted QC: 2006-03-03
• Study First Posted: 2006-03-07
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-23
• Last Update Posted: 2006-08-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

18 years old or older Diagnosis of solid tumor or hematologic malignancy Starting active treatment (chemotherapy or hormonal therapy) Must be able to give informed consent & consent to use the Cancer Symptom Monitor -

Exclusion Criteria

Inability to give informed consent Life expectancy of less than 3 months Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Community Regional Cancer Center-Community Hospital North; 🇺🇸 Indianapolis, Indiana, United States

Morgan Hospital and Medical Center; 🇺🇸 Martinsville, Indiana, United States

Quality Oncology Care, Inc.; 🇺🇸 Indianapolis, Indiana, United States