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

Sponsors and Collaborators:	Community Cancer Care Amgen
Information provided by:	Community Cancer Care
ClinicalTrials.gov Identifier:	NCT00300001

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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

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
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

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.

Cleeland CS, Reyes-Gibby CC. When is it justified to treat symptoms? Measuring symptom burden. Oncology (Williston Park). 2002 Sep;16(9 Suppl 10):64-70. Review.

Chang VT, Ingham J. Symptom control. Cancer Investigation. 2003; 21: 564-578.

Patrick DL, Ferketich SL, Frame PS, Harris JJ, Hendricks CB, Levin B, Link MP, Lustig C, McLaughlin J, Ried LD, Turrisi AT 3rd, Unutzer J, Vernon SW; National Institutes of Health State-of-the-Science Panel. National Institutes of Health State-of-the-Science Conference Statement: Symptom Management in Cancer: Pain, Depression, and Fatigue, July 15-17, 2002. J Natl Cancer Inst. 2003 Aug 6;95(15):1110-7. Review.

Passik SD, Dugan W, McDonald MV, Rosenfeld B, Theobald DE, Edgerton S. Oncologists' recognition of depression in their patients with cancer. J Clin Oncol. 1998 Apr;16(4):1594-600.

McDonald MV, Passik SD, Dugan W, Rosenfeld B, Theobald DE, Edgerton S. Nurses' recognition of depression in their patients with cancer. Oncol Nurs Forum. 1999 Apr;26(3):593-9.

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.

Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. Review.

Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46.

Schubert MM, Williams BE, Lloid ME, Donaldson G, Chapko MK. Clinical assessment scale for the rating of oral mucosal changes associated with bone marrow transplantation. Development of an oral mucositis index. Cancer. 1992 May 15;69(10):2469-77.

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.

Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9.

Morgan, D. Focus Groups as Qualitative Research. Sage Publications. Thousand Oakes, CA, 1997.

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

Keywords provided by Community Cancer Care:

Cancer
Symptom Management
Supportive Symptom Interventions

Symptom Severity
quality of life
Home-based symptom monitoring

Study placed in the following topic categories:

Hematologic Neoplasms
Hematologic Diseases
Quality of Life

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009