Clinical trial NCT00300001: Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes
Official title: Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Solid Tumor
Hematologic Malignancy
Keywords: Cancer
Symptom Management
Supportive Symptom Interventions
Symptom Severity
quality of life
Home-based symptom monitoring
Lead sponsor: Community Cancer Care
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2006-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Quality Oncology Care, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Community Regional Cancer Center-Community Hospital North
state: Indiana
city: Martinsville
country: United States
facility: Morgan Hospital and Medical Center
state: Indiana
Study officials:
affiliation: Community Cancer Care, Inc.
name: Dale E. Theobald, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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