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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Community Cancer Care.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Amgen
Information provided by:
Community Cancer Care
ClinicalTrials.gov Identifier:
NCT00300001
First received: March 3, 2006
Last updated: August 23, 2006
Last verified: August 2006
  Purpose

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
Cancer
Solid Tumor
Hematologic Malignancy

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Home-Based Symptom Monitoring: Its Impact on Cancer Care Team Behaviors and Patient Outcomes

Resource links provided by NLM:


Further study details as provided by Community Cancer Care:

Estimated Enrollment: 300
Study Start Date: March 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300001

Contacts
Contact: Dale E Theobald, PhD, MD 317-621-4325 dtheobald@ecommunity.com
Contact: Donna L Butler, MSN 317-621-4305 dbutler@ecommunity.com

Locations
United States, Indiana
Community Regional Cancer Center-Community Hospital North Recruiting
Indianapolis, Indiana, United States, 46256
Principal Investigator: Dale E Theobald, PhD, MD         
Quality Oncology Care, Inc. Recruiting
Indianapolis, Indiana, United States, 46202
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
Amgen
Investigators
Principal Investigator: Dale E. Theobald, PhD, MD Community Cancer Care, Inc.
  More Information

Publications:
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.
Chang VT, Ingham J. Symptom control. Cancer Investigation. 2003; 21: 564-578.
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
Study First Received: March 3, 2006
Last Updated: August 23, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014