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

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ClinicalTrials.gov Identifier: NCT00300001
Recruitment Status : Unknown
Verified August 2006 by Community Cancer Care.
Recruitment status was:  Recruiting
First Posted : March 7, 2006
Last Update Posted : August 25, 2006
Information provided by:
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.

Condition or disease
Cancer Solid Tumor Hematologic Malignancy

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 Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes
Study Start Date : March 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300001

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         
Sponsors and Collaborators
Community Cancer Care
Principal Investigator: Dale E. Theobald, PhD, MD Community Cancer Care, Inc.

Berger AM, Portenoy RK, Weissman DE., Eds. Principles and Practice of Supportive Oncology, 2nd Ed.; Lippincott-Raven: Philadelphia, 2002.
Max MB, Portenoy RK, Laska EM, Eds. Oxford Textbook of Palliative Medicine, 2nd Ed.; Oxford Medical Publications: New York, 1998.
Oncology Nursing Society, Research Agenda, 2003-2205. Available at http://www.ons.org/images/PDFs/Research/2003Plan.pdf.
Theobald DE, Butler D, Abdullah M, Perkins A, Edgerton S, Dugan WM. Access to communication technologies in a sample of cancer patients in Indiana: An urban and rural survey. (Poster Discussion) National Rural Health Meetings, San Diego, 2004.
Theobald DE, Butler D, Coburn J, et al. IVR-based cancer symptom assessment: Nurses’ expectations and perceived barriers. (Abstract) Am Soc Clin Oncol, New Orleans, 2004.
Kreuger RA. Focus Groups: A practical guide for Applied Research. Sage Publications: Thousand Oakes, CA, 1994.
Munhall P. Nursing Research: A qualitative perspective, third edition. 2001.
Morgan, D. Focus Groups as Qualitative Research. Sage Publications. Thousand Oakes, CA, 1997.

ClinicalTrials.gov Identifier: NCT00300001     History of Changes
Other Study ID Numbers: 2005-0186
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: August 25, 2006
Last Verified: August 2006

Keywords provided by Community Cancer Care:
Symptom Management
Supportive Symptom Interventions
Symptom Severity
quality of life
Home-based symptom monitoring