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Sponsors and Collaborators: |
Community Cancer Care Amgen |
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Information provided by: | Community Cancer Care |
ClinicalTrials.gov Identifier: | NCT00300001 |
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.
Condition |
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Cancer Solid Tumor Hematologic Malignancy |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes |
Estimated Enrollment: | 300 |
Study Start Date: | March 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contact: Dale E Theobald, PhD, MD | 317-621-4325 | dtheobald@ecommunity.com |
Contact: Donna L Butler, MSN | 317-621-4305 | dbutler@ecommunity.com |
United States, Indiana | |
Quality Oncology Care, Inc. | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: Dale E Theobald, PhD, MD | |
Community Regional Cancer Center-Community Hospital North | Recruiting |
Indianapolis, Indiana, United States, 46256 | |
Principal Investigator: Dale E Theobald, PhD, MD | |
Morgan Hospital and Medical Center | Recruiting |
Martinsville, Indiana, United States, 46151 | |
Principal Investigator: Dale E. Theobald, PhD, MD |
Principal Investigator: | Dale E. Theobald, PhD, MD | Community Cancer Care, Inc. |
Study ID Numbers: | 2005-0186 |
Study First Received: | March 3, 2006 |
Last Updated: | August 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00300001 |
Health Authority: | United States: Institutional Review Board |
Cancer Symptom Management Supportive Symptom Interventions |
Symptom Severity quality of life Home-based symptom monitoring |
Hematologic Neoplasms Hematologic Diseases Quality of Life |
Neoplasms Neoplasms by Site |